Fever (rectal temperature >38°C) 2,3 in a newborn baby can be the first indicator of a serious invasive infective illness. Conversely, hypothermia (rectal temperature <36.5°C) 4 can also be a sign of sepsis, as neonates have difficulty regulating temperatures. 5 The health of neonates with sepsis can deteriorate rapidly; therefore, if a fever is detected (gold standard is to take the rectal temperature, but axillary or temporal artery temperature are acceptable), the baby requires immediate referral to the emergency department for a full septic workup, and hospital admission for empirical antibiotics. Ambulance retrieval may be necessary for babies who have associated signs of haemodynamic instability, acute respiratory distress and/or are non-responsive. A full septic workup should include a full blood count and film, blood culture, urine culture (through aseptic suprapubic aspiration), lumbar puncture and, if clinically indicated, a chest X-ray. 3 Where possible, it is recommended that neonates with suspected sepsis be admitted to hospital and treated with intravenous antibiotics; oral antibiotics may lead to only partial treatment and false‑negative culture results. 6
Respiratory symptoms are common and the majority will be benign. However, it is important not to miss the acutely unwell baby in respiratory distress, as these babies should be transferred to the emergency department via ambulance. 7 Table 2 outlines the signs and causes of acute respiratory distress outside the first 24 hours of life, and other common respiratory presenting concerns and conditions. In neonates, a cough can be due to a common viral upper respiratory tract infection, but it can also be a sign of a more significant pathology. Babies who have a cough and any associated ‘red flag’ signs or symptoms outlined in Table 2 should be referred for further investigation with a paediatrician. Clinical suspicion of pertussis infection warrants referral to the emergency department for laboratory confirmation, antimicrobials and monitoring, as these babies are at greatest risk of complications with apnoea, pneumonia, encephalopathy and death. 8
Clinical presentation | Differential diagnoses | Red flags or supporting features |
(eg tachypnoea, accessory muscle use, central cyanosis, nasal flaring, expiratory grunting) | Infection | |
Foreign body | ||
Trauma | ||
Congenital heart disease | ||
Metabolic acidosis | ||
Respiratory infection | ) | |
Tracheo-oesophageal fistula | ||
Chronic lung disease | ||
Tracheo-bronchomalacia | ||
Congenital heart disease | ||
Laryngomalacia | ||
Tracheomalacia | ||
Laryngeal / subglottic mass | ||
Choanal atresia | ||
Vocal cord paralysis | ||
Brief resolved unexplained event | ||
Apnoea of prematurity | ||
Infection | ||
Head trauma | ||
Structural airway obstruction |
Neonates are obligatory nose breathers, and nasal congestion with mucus often results in noisy breathing. Normal saline drops or spray may relieve some of the nasal congestion. The most common pathological cause of noisy breathing is laryngomalacia. This developmental anomaly causes stridor through collapse of the supraglottic structures during inspiration. Babies with mild laryngomalacia who are feeding well and thriving can be regularly reviewed in the GP setting. Parents should be advised that stridor may become louder in the first six months of life, but will usually resolve by 12–18 months. Babies who have associated complications (eg poor feeding, gastro-oesophageal reflux [GOR]) should be referred to a respiratory paediatrician or otolaryngologist for further assessment. 9
Parental concerns regarding irregular breathing or pauses in their baby's breathing are also common GP presentations. In the majority of neonates, these irregularities will be due to ‘periodic breathing’, which is a normal developmental phenomenon. Periodic breathing is characterised by alternating cycles of five to 10 seconds of breathing and pauses in breathing. It is not associated with bradycardia or cyanosis. It increases in frequency between two and four weeks of age and resolves by six months of age. 10 Apnoea is defined as pauses in breathing of greater than 20 seconds, or shorter duration if accompanied by cyanosis or bradycardia. 10,11 This is of great concern, and a significant medical cause needs to be excluded. If a medical cause is not evident following clinical assessment, these babies are classified as having had a brief resolved unexplained event (BRUE). BRUE replaces the previous terminology: apparent life threatening event (ALTE). 10 BRUEs can be stratified into low risk and high risk, where low-risk BRUEs generally do not require hospital admission or invasive testing. 12 All neonatal BRUEs are categorised as high risk, given the age of the baby, 12 and should be reviewed by a paediatrician for further investigation. Table 2 summarises common causes of apnoea.
Small amounts of effortless posseting or physiological GOR are common in babies. In otherwise well babies who are feeding adequately and thriving, parental reassurance that this is most likely to improve in the first year of life is sufficient. General measures, such as holding the baby in the prone position after feeds and thickening agents, may help reduce the vomiting. Acid-suppression agents (ie H2-agonists, proton-pump inhibitors) should be reserved for babies with associated complications, such as inadequate weight gain, oesophagitis or aspiration. 13 There is no clear causal link between GOR and infant irritability, and anti-reflux medication is generally not warranted in these instances. 14 Vomiting as a result of a more serious condition, such as pyloric stenosis, intestinal obstruction, sepsis or neurological cause (eg subdural or intracranial haemorrhage, hydrocephalus), needs to be promptly referred to the emergency department. Red flags for these conditions include projectile vomiting immediately post-feeds (associated with demands to be re-fed soon after), bilious vomiting, acute abdominal distension, fever, lethargy, dehydration or bulging fontanelle.
There is no universally agreed clinical definition of constipation for neonates. They may pass bowel motions several times a day or have more than a week between bowel motions. Formula-fed babies typically produce firmer and less frequent stools than breastfed babies, but unless these are hard and pellet-like, the baby is unlikely to be constipated. 15 Some babies will strain and cry for longer than 10 minutes before passing soft stools. This phenomenon, known as dyschezia, is caused by an inability to coordinate the increase in intra-abdominal pressure with pelvic floor relaxation. 16 It is a functional, self-limiting condition, and is not due to constipation. Caution should be applied and organic pathology excluded before prescribing laxatives in neonates. Clinical history and examination will detect some significant conditions, including:
Cutaneous lesions over the sacrococcygeal region may be indicative of closed spinal dysraphism.
It is also normal for newborn babies to have frequent, loose stools. Babies who have true diarrhoea will produce more watery and more frequent stools than usual. The most common causes of diarrhoea in neonates are viral or bacterial infections or cow’s milk protein allergy (CMPA). Babies with acute infective diarrhoea (gastroenteritis) need to be monitored closely for dehydration. Table 3 outlines the signs of dehydration and other signs of the unwell baby that should prompt early transfer to hospital. Admission to hospital should also be considered for those who are unlikely to maintain adequate oral intake at home. Antimicrobial therapy is rarely warranted in gastroenteritis, as most cases are viral and/or self-limiting.
Vital signs | |
Signs of dehydration | |
Systemic specific signs | |
Non-specific signs |
All newborn babies cry. Normal infant crying patterns tend to increase in duration week by week, peaking at around six to eight weeks of age, and receding to lower, stable levels at around four to five months of age. 17,18 The typical presentation is clustered periods of inconsolable crying, some for more than two to three hours in duration, often in the late afternoon and evening. In otherwise well babies, reassurance, support and review in the first few months can be therapeutic tools in their own right. The exclusion of pain or ‘wind’ as the cause of crying will help to reassure parents. Box 1 lists some parental education resources on normal infant development, unsettled babies and breastfeeding. Alternative therapies, such as simethicone, herbal treatment, acupuncture and manipulation techniques, are not supported by the evidence. 19 Advice to change from breastmilk to formula, or to change between formula brands, should be avoided. 20 There is emerging evidence that probiotics may be helpful in settling breastfed babies, but currently there is no universal consensus for this to be a standard recommendation. 21,22
As part of the assessment of an unsettled baby, it is important not to miss a pathological cause. If there is a sudden onset of persistent crying, an acute pathology such as infection, hair tourniquet (ie strangulation of an appendage or digit by a thread-like material, such as hair), corneal abrasion and non-accidental injury should be considered.19 CMPA is a recognised cause for the unsettled baby. Supporting features for CMPA include blood and mucus in the stool, diarrhoea or constipation, inadequate weight gain, eczema, and family history of atopy. A cow’s milk exclusion diet (including mothers if breastfeeding) may be trialled in these babies to confirm the diagnosis. In babies who are formula-fed, a trial of extensively hydrolysed formula and/or amino acid formula will be required. Soy infant formulas are not recommended in infants younger than six months of age. Rice protein-based formulas can be used as a short-term, non-prescription alternative while awaiting specialist review. 23 Referral to a paediatrician or allergy specialist and dietitian is recommended for suspected cases of CMPA to ensure adequate parental education and future dietary management.
Prematurity (gestation <37 weeks) is the most common cause of feeding difficulties in neonates. Their immature physiology can result in discoordination between sucking, swallowing and breathing. 24 Breastfeeding, however, can be a challenging process for any new mother. Support from a maternal child health nurse or lactation consultant can result in positive outcomes for both mothers and their babies. Tongue-tie, or ankyloglossia, has long been linked with difficult breastfeeding and maternal nipple pain. A Cochrane meta-analysis found that frenotomy (surgical release of tongue-tie) reduced maternal nipple pain in the short term, but did not find consistent positive effects on breastfeeding. 25 Maternal nipple pain is, however, a common reason for cessation of breastfeeding and early referral for frenotomy may prevent this. 26
Breastfeeding may not be a viable option for all mothers, and advice regarding infant formula, expressed breast milk, or a mixture of the two should be made available in a supportive and non-judgemental manner. Babies can lose up to 10% of their birthweight in the first week of life, and may take a further two weeks to regain their birthweight. 27,28
It is therefore more important to track the actual weight difference in grams between visits. Following the initial postpartum weight loss, newborns are expected to gain 30–40 grams per day on average. 28 ‘Failure to thrive’ or inadequate weight gain is most commonly a result of inadequate oral intake. If a baby continues to display inadequate weight gain despite increased feed frequency and/or supplementary feeds, referral to a paediatrician for further investigation and management should be made.
Jaundice, or hyperbilirubinaemia, is the result of bilirubin pigment deposition in the skin and mucous membranes. In the majority of cases, jaundice in neonates is due to unconjugated hyperbilirubinaemia. Conjugated hyperbilirubinaemia or ‘cholestatic jaundice’ is always pathological, and detection of this should prompt immediate review with a paediatric gastroenterologist. 29 The following discussion is in relation to unconjugated hyperbilirubinaemia.
Visual assessment of jaundice alone is an unreliable indicator of the degree of hyperbilirubinaemia. Assessment should include detection of any signs of bilirubin toxicity (Table 3), and identification of risk factors, including the following: 30
Babies with jaundice and added signs of bilirubin toxicity require immediate referral to hospital. Babies with prolonged jaundice who are otherwise well looking, feeding adequately and with no risk factors are most likely to have physiological jaundice or breastmilk jaundice, and can be managed as outpatients. A bilirubin level (total and fractionated) should be checked with early follow-up for results and clinical review. Bilirubin threshold tables (www.nice.org.uk/guidance/cg98) should be used to determine whether the baby requires treatment with phototherapy or exchange transfusion. 31
In any baby who presents with a vesiculopustular rash, significant causes such as bacterial, viral and fungal infections need to be considered. If a rash is accompanied by systemic signs of being unwell, such as fever, lethargy or poor feeding, then the baby needs to be referred immediately to the emergency department for further assessment. Recent exposure to infectious diseases such as Varicella‑Zoster virus (VZV) or Herpes simplex virus (HSV), should also alert the physician to the possibility of an invasive infective disease.
Common benign rashes that may present in the newborn include erythema toxicum and milia. Erythema toxicum is a benign, self-limiting skin condition categorised by small erythematous papules, vesicles and pustules. It affects 30–70% of newborns, typically within the first two weeks of birth. 32 Erythema toxicum can be differentiated from an infective rash by its tendency to wax and wane over several days. It is also unusual for an individual erythema toxicum lesion to persist for more than one day. If the infant is otherwise well, no investigation or treatment is required, but recommendation for review should be made if the rash does not resolve after one to two weeks. Milia, which are a result of blocked pores, typically present as tiny, white cysts on the face in about 40–50% of newborns. 33 Most lesions resolve after one to two months. Parents should be reassured and advised to not squeeze or pick them as this may result in infection or scarring.
Neonatal assessment can be challenging because of the non-specific nature of presenting signs and symptoms. A thorough clinical assessment, including relevant maternal medical, antenatal, peripartum and postpartum histories, with a systematic physical examination, is the most important tool in the primary clinic setting.
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neonates ongoing medical education paediatrics
High-quality universal newborn health care is the right of every newborn everywhere. Babies have the right to be protected from injury and infection, to breathe normally, to be warm and to be fed. All newborns should have access to essential newborn care, which is the critical care for all babies in the first days after birth. Essential newborn care involves immediate care at the time of birth, and essential care during the entire newborn period. It is needed both in the health facility and at home.
Essential newborn care includes:
Monitoring and data
This up-to-date, comprehensive and consolidated guideline on essential intrapartum care brings together new and existing WHO recommendations that, when...
This guideline aims to improve the quality of essential, routine postnatal care for women and newborns with the ultimate goal of improving maternal and...
Quality of care
Deaths in the neonatal period (the first 28 days of life) now represent nearly half (47%) of all deaths of children under 5 years, with 2.5 million neonatal...
Newborn care is a fundamental aspect of pediatric nursing, focusing on providing essential support and nurturing to newborns during their critical early days of life.
This nursing note explains the key components of newborn care, including assessment (Agpar scoring, respiratory and physical examination), feeding , hygiene , and promoting bonding between parents and their newborns.
Apgar scoring, respiratory evaluation, physical examination, care of the newborn at birth.
Assessment of the newborn immediately starts the moment he or she is delivered, and there are a lot of standard assessments used to evaluate them rapidly.
The Apgar scoring is done during the first 1 minute and 5 minutes of life. The heart rate , respiratory rate, muscle tone, reflex irritability, and color are evaluated in an infant. Apgar score is the baseline for all future observations.
Indicator | 0 | 1 | 2 | |
---|---|---|---|---|
A | Activity | Absent | Flexed arms and legs | Active |
Pulse | Absent | Below 100 bpm | Over 100 bpm | |
Grimace | Floppy | Minimal response to stimulation | Prompt response to stimulation | |
Appearance | Blue; pale | Pink body, blue extremities | Pink | |
Respiration | Absent | Slow & irregular | Vigorous cry |
Apgar scoring
The care of the newborn starts at the hand of their healthcare providers and must be transitioned properly to their parents for continuity of care. An appropriate education for the parents and immediate family members regarding the dos and don’ts for newborn care should be included in the discharge plan so that when the newborn is already safe at home, there is a guarantee that they are well-cared for by their family members.
My sister recently gave birth to a healthy baby boy named Thomas. My sister then asked me to find a newborn care clinic that can assist her in handling the baby for the first few weeks. As I was looking for a pediatric clinic, I had no idea until I’ve read in your article that it is during the postpartum period where vaccination for Hepatitis B and Vitamin K should be done. I shall then inform my sister about this.
Hepatitis B vaccination and Vitamin K administration is usually given immediately after birth in hospital settings.
Statistical research shows that putting a baby to sleep with a pacifier three to four weeks when breastfeeding is established, decreases S.I.D.S. significantly.
Thank you so much, It is very effective learning lesson, for manage the newborn immediate after birth.
Thanks,can I get management of preterm baby kindly
Can I suggest/request your content regarding washing baby an hour post birth be reviewed/updated please? (See information relating infant temperature regulation, protective aspects of vernix for neonates, microbiome/immunity, etc).
VERA LOENING-BAUCKE, M.D., AND KEN KIMURA, M.D.
This is a corrected version of the article that appeared in print.
Am Fam Physician. 1999;60(7):2043-2050
Timely passage of the first stool is a hallmark of the well-being of the newborn infant. Failure of a full-term newborn to pass meconium in the first 24 hours may signal intestinal obstruction. Lower intestinal obstruction may be associated with disorders such as Hirschsprung's disease, anorectal malformations, meconium plug syndrome, small left colon syndrome, hypoganglionosis, neuronal intestinal dysplasia and megacystis-microcolon-intestinal hypoperistalsis syndrome. Radiologic studies are usually required to make the diagnosis. In addition, specific tests such as pelvic magnetic resonance imaging, anorectal manometry and rectal biopsy are helpful in the evaluation of newborns with failure to pass meconium.
The first stool is passed within 24 hours of birth in 99 percent of healthy full-term infants and within 48 hours in all healthy full-term infants. 1 Failure of a full-term newborn to pass meconium within the first 24 hours should raise a suspicion of intestinal obstruction. Among premature infants, however, one study 2 revealed that only 37 percent of 844 preterm infants passed their first stool in the first 24 hours; 32 percent had delayed passage of the first stool beyond 48 hours. In 99 percent of the preterm infants, the first stool was passed by the ninth day after birth.
Failure to pass meconium combined with progressive abdominal distention, refusal to feed and vomiting of bilious intestinal contents are the classic clinical signs of intestinal obstruction in neonates. Abdominal examination often reveals distended loops of bowel, which may be visible or palpable. Anal inspection is essential to exclude the presence of anal atresia, perineal fistula with anal atresia, the membranous form of anal atresia and anal stenosis.
Plain radiographs of the abdomen do not allow differentiation of small bowel obstruction from large bowel obstruction. The differential diagnosis for small bowel obstruction in neonates includes duodenal atresia, malrotation and volvulus, jejunoileal atresia, meconium ileus and meconium peritonitis. Bilious vomiting, with or without abdominal distention, is usually the first sign of small bowel obstruction. The differential diagnosis for large bowel obstruction in neonates includes Hirschsprung's disease, anorectal malformations and meconium plug syndrome ( Table 1 ) .
Hirschsprung's disease | 1/4,000 | Tight anus, empty rectum, transition zone | Surgery |
Meconium plug syndrome | 1/500 to 1/1,000 | Meconium plugs | Rectal stimulation, enema |
Meconium ileus | 1/2,800 | Abdominal distention at birth, cystic fibrosis | Enema with intravenous fluids, surgery |
Anorectal malformation | 1/4,000 to 1/8,000 | Absent anus, tight anus or fistula | Dilatation, surgery |
Small left colon syndrome | Rare | Transition zone at splenic flexure | Enema, rarely, colostomy |
Hypoganglionosis | Rare | Transition zone | Medical, TPN, surgery |
Neuronal intestinal dysplasia type A | Rare | Transition zone, mucosal Inflammation | Medical, surgery |
Neuronal intestinal dysplasia type B | Rare | Megacolon | Medical, rarely, surgery |
Megacystis-microcolon-intestinal hypoperistalsis syndrome | Very rare | Microcolon, megacystis | TPN |
In many cases of suspected neonatal intestinal obstruction, the clinical history and physical examination combined with plain abdominal radiographs, contrast enema radiographic examination, anorectal manometry and rectal biopsy eventually yield the diagnosis. The most difficult management decision is to decide between conservative management and emergency surgery. Ideally, all newborns suspected of having bowel obstruction should receive treatment at a center where a pediatric surgeon is available.
A 3,480 g (7 lb, 7 oz) male infant was born after 40 weeks' gestation. There were no complications during the pregnancy and delivery. He did not pass meconium after birth, and he had the onset of vomiting on the first day. His abdomen became mildly distended. The infant was not able to feed, and abdominal distention increased.
Rectal examination revealed a tight anus. On the second day, flat and upright abdominal films demonstrated numerous loops of dilated bowel ( Figure 1a ) . Barium enema radiographic examination showed that most of the dilated bowel was colon; no transition zone was seen ( Figure 1b ) .
The surgeon performed an anal dilatation, and the infant subsequently passed gas and meconium, which was followed by resolution of all symptoms.
After discharge from the hospital, the infant's mother continued performing periodic anal dilatation because he had difficulties moving his bowel. Digital rectal examination by the physician when the infant was five weeks of age revealed a tight anus and liquid stool but no impaction.
One week later, the mother noticed a bloody ring around his bowel movements. Barium enema radiographic examination at this time showed a transition zone in the distal portion of the sigmoid colon, with marked dilatation of the descending colon and left side of the transverse colon ( Figure 1c ) . Anorectal manometry showed an absent rectosphincteric reflex. No ganglion cells were seen in the rectal biopsy. These findings were consistent with Hirschsprung's disease.
Hirschsprung's disease, or congenital aganglionic megacolon, has an overall incidence of one in 4,000 live births. 3 It accounts for 20 to 25 percent of the cases of neonatal bowel obstruction. 4 The disease affects four times as many boys as girls, and 8 percent of patients with Hirschsprung's disease also have Down syndrome. 5 The abnormal bowel innervation affects the internal anal sphincter. Most often, the rectosigmoid is involved, but a variable length of gut can be involved. A 30-year retrospective study 6 revealed that the mean age at diagnosis has decreased to 2.6 months because of vigilance on the part of physicians, the use of anorectal manometry for assessment of the anal sphincter and early rectal biopsy to confirm the clinical diagnosis.
A common presentation of Hirschsprung's disease in the newborn is failure to pass meconium during the first few days of life, with subsequent passage of a meconium plug followed by sparse bowel movements. Gastrointestinal bleeding and diarrhea are danger signs for Hirschsprung's disease–associated enterocolitis. Enterocolitis can be fatal and is thought to be due to proliferation of bacteria as a result of stasis.
Physical examination often reveals the anus and rectum to be narrow and empty of stool. Plain abdominal radiographs show gas and stool in the colon and often the distention with stool or gas does not reach distally to the pelvic rim ( Figure 1a ) .
Barium enema radiographic examination, performed with the colon unprepared, may reveal a transition zone that separates the small-to normal-diameter aganglionic bowel from the dilated bowel above ( Figure 1c ) . A transition zone may not be recognizable in up to 25 percent of neonates with classic Hirschsprung's disease ( Figure 1b ) . Similarly, a transition zone may not be discernible in patients with ultrashort segment Hirschsprung's disease, in patients with total colonic aganglionosis in whom the transition zone is above the colon and in patients who had an emergency colostomy. The presence of barium in the 24-hour delayed film is also suggestive of Hirschsprung's disease.
When possible, anorectal manometry should be performed in all newborns with symptoms of lower bowel obstruction. With anorectal manometry, changes in anal pressure are recorded during and after rectal distention. When ganglion cells are present, rectal distention with a balloon inhibits the internal anal sphincter, resulting in a fall in anal pressure, called the rectosphincteric reflex ( Figure 2a ) . In patients with Hirschsprung's disease, the rectosphincteric reflex is absent ( Figure 2b ) .
Anorectal manometry is most helpful in excluding the diagnosis of Hirschsprung's disease in a newborn. 7 , 8 If the rectosphincteric reflex is absent, the diagnosis of Hirschsprung's disease needs to be confirmed by rectal suction biopsy, which shows no ganglion cells and markedly increased acetylcholinesterase staining of increased coarse neural fibers within the muscularis mucosae and the lamina propria.
Surgery to remove or bypass the diseased bowel is required in all children with Hirschsprung's disease. In most neonates, a colostomy is initially placed into the normal bowel for decompression, followed by corrective surgery in three to six months. Occasionally, a primary pull-through procedure is performed.
Meconium plug syndrome is the mildest and most common form of functional distal obstruction in the newborn. 9 It is a transient form of distal colonic or rectal obstruction caused by inspissated, immobile meconium. The incidence of meconium plug syndrome is estimated to range from one case in 500 to one case in 1,000 neonates. 10 The etiology of this disorder is unclear.
The plain abdominal radiograph often reveals generalized gaseous distention of intestinal loops of small and large bowel filling the entire abdomen, but with no fluid levels. Contrast enema is diagnostic, showing the outline of the meconium plug ( Figure 3 ) , and also therapeutic if the plug is passed afterward. In some newborns, rectal stimulation with a thermometer, digital rectal examination or a saline enema induces passage of the plug. After the plug is passed, bowel movements are normal, and all symptoms resolve. However, even neonates with organic disease, such as Hirschsprung's disease, may pass a meconium plug and do well for a period of time. Therefore, continued observation is required in infants who pass a meconium plug and, if symptoms persist, further work-up is required.
Another cause of neonatal bowel obstruction by thick tenacious meconium is meconium ileus. Meconium ileus accounts for about 30 percent of cases of intestinal obstruction in newborns. 11 In approximately 50 percent of the newborns with meconium ileus, the gut is undamaged and continuity is not disrupted; the obstruction is merely due to intraluminal meconium. 9 In the other infants, meconium ileus is associated with volvulus, atresia or perforation. 9 Cystic fibrosis is the underlying disorder in most infants with meconium ileus. 9 Meconium ileus occurs in 15 percent of patients with cystic fibrosis. 12
Typically, abdominal distention is present at birth. Within hours, as air is swallowed, the distention increases, and the infant vomits bile-stained material. Thickened bowel loops are often palpable and visible through the abdominal wall. Massive distention, abdominal tenderness or abdominal erythema indicates the presence of complications. Rectal examination is often difficult because of the small caliber of the rectum.
Abdominal radiographs may reveal a distended bowel, few air-fluid levels and, in the right lower abdomen, meconium mixed with air, which has a ground-glass appearance on plain film. The presence of calcifications, free air or very large air-fluid levels suggests complications. The difference between meconium ileus and meconium plug syndrome is in the site and severity of the obstruction.
Contrast enema radiographic examination demonstrates a microcolon, often with no bowel contents. Reflux of contrast into the small bowel reveals the plugs. The small bowel is of narrow caliber below the plug and dilated above the plug.
Simple meconium ileus may be successfully treated by administration of a diatrizoate meglumine (Gastrografin) enema and plenty of intravenous fluids; the success rate is 16 percent 12 to 50 percent. 13 If the Gastrografin enema is unsuccessful, operative evacuation of the obstructing meconium by irrigation will be necessary. Complications such as atresia, perforation and meconium peritonitis always require immediate surgery, including resection, intestinal anastomosis and ileostomy.
One in 4,000 to one in 8,000 newborns is born with an anorectal malformation. 14 A spectrum of anomalies of the lower intestinal tract and the genitourinary structures occurs from a failure of the completion of the complex embryologic developmental sequences in which the growth of the urorectal septum, lateral mesoderm structures and ectodermal structures form the normal rectum and lower urinary tract.
Anal stenosis accounts for approximately 20 percent of anorectal malformations. 4 The anus is very small, and a central black dot of meconium is present. Intense efforts are required to pass a ribbon-like stool. The diagnosis of anal stenosis is established by demonstration of a small, tight anus. Occasionally, an anal web may be the cause of the small anus. Anal dilatation is the usual treatment for anal stenosis and may need to be continued for several months.
Anal atresia affects males and females with equal frequency. Perineal inspection reveals the absent anus ( Figure 4 ) . Broadly classified, anal atresia is characterized as “high” or “low,” depending on whether the rectum ends above the levator muscle or partially descends through this muscle. Often, the rectum ends in a fistula. In the high type of anal atresia, the fistula often ends in the prostatic urethra in males and in the vagina in females ( Figure 5 ) .
Patients with a low type of anal atresia usually have a well-formed sacrum, a prominent midline groove and a prominent anal dimple. The low lesions are associated with a cutaneous fistula to the perineum. The orifice is small, located in the perineum anterior to the center of the external anal sphincter, close to the scrotum in the male and the vulva in the female. The abnormal anterior position of the fistula opening is occasionally not obvious and is mistaken for the anus. Males frequently have a black, ribbon-type structure in the perineum, which represents a subepithelial fistula filled with meconium.
Associated anomalies are present in up to 70 percent of patients with anorectal malformation. 9 About 50 percent have urologic problems. 15 The mnemonic VACTERL is used to describe the association of a combination of v ertebral defects, a nal atresia, c ardiac defects, t racheoesophageal fistula with e sophageal atresia, r enal defects and radial upper l imb hypoplasia.
Anal atresia requires surgical correction. The goal is to preserve bowel, urinary and sexual function. A colostomy is initially performed in neonates with high anal atresia. If a fistula is present on the perineum or in the vagina, it can be gently dilated to allow the gas and meconium to pass. Low lesions, including those with perineal fistulas, can be corrected electively when the infant's condition is stable.
A rare cause of neonatal intestinal obstruction is small left colon syndrome, a functional distal bowel obstruction secondary to transient dysmotility in the descending colon. 16 With this disorder, abdominal distention often develops after the newborn has passed meconium. More than 50 percent of newborns with small left colon syndrome are infants of mothers who have diabetes or an abnormal glucose tolerance test. 16 Other infants are hypoglycemic or septic and, in others, an association with hypothyroidism, hypermagnesemia and maternal use of psychotropic drugs has been reported.
Plain radiograph shows dilated intestinal loops ( Figure 6a ) and, often, air-fluid levels. Contrast studies show the colon to be shortened and to lack the usual tortuosity from the anus to the splenic flexure. A sharp transition zone is seen at the splenic flexure ( Figure 6b ) .
Rectal biopsy in patients with small left colon syndrome shows ganglion cells, contrary to the absence of ganglion cells in patients with Hirschsprung's disease. The ganglion cells can be normal, immature or hyperganglionic. The clinical course in newborns with small left colon syndrome varies in severity from mild symptoms, which may be relieved by the contrast enema, to severe bowel obstruction requiring a temporary transverse colostomy. 16 Newborns with small left colon syndrome eventually have normal intestinal motility.
Various maternal medical conditions can cause a delay in meconium passage. In addition, maternal drug use, such as illicit drugs, magnesium sulfate and ganglionic blocking agents, can affect the infant and interfere with the passage of meconium. Neonatal medical conditions that can be associated with a failure to pass meconium include hypothyroidism, hypercalcemia, hypokalemia, sepsis and congestive heart failure.
Hypoganglionosis and neuronal intestinal dysplasia type A can produce symptoms and radiographic findings similar to those of Hirschsprung's disease. 17 – 21 Both of these diseases are rare. They can affect part of or all of the gastrointestinal tract and sometimes occur in combination with Hirschsprung's disease. Histologically, hypoganglionosis is characterized by a reduced number of ganglion cells. In neuronal intestinal dysplasia type A, histologic features include hypoplasia or aplasia of the sympathetic innervation of the myenteric plexus and mucosa, along with mucosal inflammation.
Neuronal intestinal dysplasia type B may be manifested in the newborn period as meconium plug syndrome, small left colon syndrome or megacystis-microcolon-intestinal hypoperistalsis syndrome. The biopsy shows a dysplastic submucosal plexus and numerous giant ganglia, with many giant and small ganglion cells.
Various medications, partial or total parenteral nutrition, or surgery to remove or bypass segments of bowel may be necessary in patients with hypoganglionosis and neuronal intestinal dysplasia.
Another rare cause of neonatal intestinal obstruction is the megacystis-microcolon-intestinal hypoperistalsis syndrome. 22 In this disorder, the small bowel is dilated and shortened, and the colon is a microcolon ( Figure 7 ) . There is an abundance of ganglion cells in the entire gastrointestinal tract. All patients with this syndrome have megacystis and megaureters, and most eventually die of complications from the disorder.
Clark DA. Times of first void and first stool in 500 newborns. Pediatrics. 1977;60:457-9.
Weaver LT, Lucas A. Development of bowel habit in preterm infants. Arch Dis Child. 1993;68:317-20.
Spouge D, Baird PA. Hirschsprung's disease in a large birth cohort. Teratology. 1985;32(2):171-7.
Fitzgerald JF. Constipation in children. Pediatr Rev. 1987;8(10):299-302.
Ryan ET, Ecker JL, Christakis NA, Folkman J. Hirschsprung's disease: associated abnormalities and demography. J Pediatr Surg. 1992;27:76-81.
Klein MD, Philippart AI. Hirschsprung's disease: three decades' experience at a single institution. J Pediatr Surg. 1993;28:1291-4.
Loening-Baucke V, Pringle KC, Ekwo EE. Anorectal manometry for the exclusion of Hirschsprung's disease in neonates. J Pediatr Gastroenterol Nutr. 1985;4:596-603.
Loening-Baucke V. Anorectal manometry: experience with strain gauge transducers for the diagnosis of Hirschsprung's disease. J Pediatr Surg. 1983;18:595-600.
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Peña A. Imperforate anus and cloacal malformations. In: Ashcraft KW, Holder TM, eds. Pediatric surgery. 2d ed. Philadelphia: Saunders, 1993:372–92.
Rich MA, Brock WA, Peña A. Spectrum of genitourinary malformations in patients with imperforate anus. Pediatr Surg Int. 1988;3:110-3.
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Fadda B, Pistor G, Meier-Ruge W, Hofmann-von Kapherr S, Müntefering H, Espinoza R. Symptoms, diagnosis, and therapy of neuronal intestinal dysplasia masked by Hirschsprung's disease. Pediatr Surg Int. 1987;2:76-80.
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Berdon WE, Baker DH, Blanc WA, Gay B, Santulli TV, Donovan C. Megacystis-microcolon-intestinal hypoperistalsis syndrome: a new cause of intestinal obstruction in the newborn. Report of radiologic findings in five newborn girls. Am J Roentgenol. 1976;126:957-64.
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Introduction, case report, conflict of interest statement, ethics statement.
Mahmoud R Manasra, Thaer Alhroob, Mohammad Marrawani, Dalia Batanje, Yahya Imran, Moatz Harahsha, Abdul-Karim Amleh, Diaa Zugayar, Perforated neonatal appendicitis mimicking necrotizing enterocolitis in a premature neonate: a case report and literature review, Journal of Surgical Case Reports , Volume 2024, Issue 7, July 2024, rjae471, https://doi.org/10.1093/jscr/rjae471
Necrotizing enterocolitis (NEC) predominantly affects preterm infants and can mimic other conditions like acute appendicitis. Neonatal appendicitis (NA) is extremely rare, with an incidence of 0.04–0.2% and high fatality rates. Due to its rarity and resemblance to other neonatal conditions, NA diagnosis is often delayed. We report a case of a 2220-g male preterm neonate delivered at 31 + 5 weeks via urgent cesarean section due to chorioamnionitis, initially misdiagnosed with NEC but later found to have a perforated appendix. The neonate recovered well post-surgery, with the ileostomy reversed 10 weeks later. Prompt surgical intervention is crucial for NA, as it requires different management than NEC. This case underscores the importance of considering NA in preterm infants with severe abdominal symptoms and emphasizes timely surgical intervention to improve outcomes. Additionally, it supports the hypothesis that localized NEC involving the appendix may have a better prognosis than generalized NEC.
An inflammatory bowel condition called necrotizing enterocolitis (NEC) mainly affects preterm infants [ 1 ]. NEC's clinical manifestation can mimic several diseases with different aetiologies [ 1 ]. One of them is acute appendicitis. 141 occurrences of appendicitis in neonates were documented between 1905 and 2000 [ 2 ], making it the most prevalent surgical diagnostic for paediatric patients that necessitates hospital admission [ 2 ]. However, it is extremely uncommon in the neonatal age group. The reported incidence ranges from 0.04 to 0.2% [ 2–4 ]. Neonatal appendicitis (NA) has a significant fatality rate [ 3 ]. Appendiceal involvement is not found until after an exploratory procedure, as the diagnosis of NA is frequently overlooked before surgery. Some variables contribute to the delay in diagnosis, such as the disease's rarity and how similar it seems to other more prevalent newborn illnesses [ 3 ]. We report a case of perforated appendicitis in a preterm neonate presenting as NEC and successfully managed by surgery.
A 2220-g male, the second part of a dichorionic-diamniotic twin as a product of in vitro fertilization, was born by urgent cesarean section (CS) with a gestational age of 31 + 5 weeks to a 24-year-old mother. The mother was on anticoagulant and aspirin therapy due to secondary infertility. A detailed ultrasound was done in the second trimester during the antenatal screening and showed no abnormalities. The mother had gestational diabetes mellitus, which was treated with an oral hypoglycemic agent; a urinary tract infection, which was treated with an oral antibiotic; and a premature preterm rupture of membranes (PPROM) 5 days before delivery, which was complicated by chorioamnionitis. As a result, an urgent CS was performed at our hospital.
The baby was delivered with Apgar scores of 8/10 at 1 and 5 minutes. Responding to brief positive pressure ventilation, he was admitted to the Neonatal Intensive Care Unit, where, on the first day, he was put on an O2 nasal cannula for support and started on a broad spectrum of prophylactic IV antibiotics due to the positive results of the placental swab culture for Escherichia coli . On the second day, after stabilization, a lumbar puncture was done, and CSF analysis showed partially treated meningitis, and antibiotics were adjusted according to culture sensitivity.
The results of the 24-hour laboratory tests showed hyperbilirubinemia, which was managed with phototherapy, and symptomatic polycythemia, for which a partial exchange transfusion was done. The baby improved clinically through the next few days of admission; he remained hemodynamically stable on room air, and tolerated oral feeding of premature milk formula or expressed breast milk with a gradual increase and weight gain until the 8th day of admission.
On the 8th day of admission, he developed severe abdominal distension, mottled skin, and a fever of 38°C. On examination, the abdomen was distended and tense on palpation, so he was put on nil per os (NPO), a nasogastric tube was placed for decompression, blood culture, arterial blood gas (ABG), CRP, CBC, stool for occult blood, and an abdominal X-ray were requested. He was started on intravenous Vancomycin, Amikacin, and Metronidazole.
The CBC showed that the white blood cell count was 2.1 × 10 9 cells/L, the platelet count was 276 ×10 9 cells/L, and the CRP level was 5.2 mg/dl. There was no occult blood in the stool, the ABG showed mild metabolic acidosis with a lactate level of 3.46, and an abdominal X-ray showed pneumoperitoneum with increased abdominal distension ( Fig. 1 ). The decision to perform an emergent exploratory transverse laparotomy was made with a presumed diagnosis of intestinal perforation as a complication of NEC.
Preoperative abdominal X-ray: lateral decubitus view showing pneumoperitoneum (white arrows).
Intraoperative findings included viable loops of the bowel with fibrinous exudates in the right lower quadrant and an inflamed appendix with perforation on the tip ( Fig. 2 ). Following an appendectomy, an ileostomy was created on the right lower quadrant, and an orogastric tube was inserted for gastric decompression. Pathologic analysis of the appendix revealed transmural inflammation, localized infarction, and perforation.
Intraoperative findings: inflamed appendix with perforation on the tip (arrow).
He was kept NPO for 7 days, then feeding was restarted gradually with good tolerability until the day of discharge. The baby increased in weight as appropriate; thus, the ileostomy was reversed 10 weeks after the surgery.
NA had less than 50 reported cases in the last 30 years and just more than 100 over the last century, making it a very rare condition [ 5 ]. The appendix obstruction is unlikely to occur due to the low incidence of infections predisposing to lymphadenopathy of the gut, soft diet, and recumbent position, which explains NA being uncommon [ 6 ]. It is rare to observe different localizing signs in the right upper quadrant of the abdomen, such as erythema, discomfort, and lumps [ 7 ]. Preoperative diagnosis is rarely made because of the lower incidence, non-specific clinical symptoms, and infrequent localizing signs. NA was found to be more common in boys than girls (3:1), and 25–50% of the reported cases were found in preterm neonates, with a third of cases initially diagnosed as NEC [ 7 ].
The way appendicitis appears in newborns lacks specificity and shares similarities with the presentation of NEC [ 8 ]. NEC is often misdiagnosed for neonatal perforated appendicitis (NPA) during the preoperative assessment, but diagnosis is conferred intraoperatively [ 9 ]. Abdominal distension, tenderness, feeding intolerance, and fever are the most frequent findings [ 2 , 7 ]. Abdominal distension, as in our patient, was the most common reported clinical feature; according to the literature, it was reported in 89% of cases [ 7 ]. Rapid development of abdominal sepsis may be complicated by the perforation of the appendix due to a delay in diagnosis [ 8 ]. NPA is present in up to 85% of cases; pneumoperitoneum is detected in only half of them [ 7 ]. The benefit of early surgical intervention is shown by the paradoxical fact that perforation predicts much lower mortality than non-perforated patients due to timely clinical recognition [ 8 ]. An 18–28% mortality rate was reported last year’s [ 8 ].
Many pieces of literature suggest that NPA in the first weeks of life may be due to an isolated form of NEC [ 6 ]. Explaining that low immunity or sepsis (prematurity, maternal chorioamnionitis) can increase the incidence of NPA [ 6 , 9 , 10 ]. Perforation due to primary appendisitis cannot be histologically distinguished from isolated NEC appendicopathy [ 8 ]. In a healthy premature neonate without comorbid risk factors for appendicitis, it’s important to consider a localised form of NEC affecting the appendix as a potential differential diagnosis for NPA. We believe that our 8-day preterm neonate had an isolated form of NEC manifested as NPA, sparing small and large intestines, which were found to be healthy. In a recent study that reviewed four cases of NPA attributable to NEC, it was suggested that the prognosis for NEC specifically involving the appendix may be more favourable than that for nonspecific NEC affecting the intestines [11]. We believe that we add another case to the literature that can support this fact, as our patient's postoperative prognosis was good.
None declared.
The authors declare that writing and publishing this manuscript was not funded by any organization.
The study was approved by the paediatric department of H-Clinic Specialty Hospital.
A written informed consent to publish this study was obtained from the parents of the patient.
Duchon J , Barbian ME , Denning PW . Necrotizing enterocolitis . Clin Perinatol 2021 ; 48 : 229 – 50 . https://doi.org/10.1016/j.clp.2021.03.002 .
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WEATHER ALERT
Bond increased for mother accused of abandoning newborn baby in southwest houston dumpster.
Christian Terry , Digital Content Producer
HOUSTON – A young mother accused of giving birth to a baby and then immediately throwing it in a dumpster in southwest Houston has had her bond increased.
Court records indicate that 18-year-old Everilda Cux-Ajtzalam has had her bond increased to $200,000.
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She was arrested on July 23 and charged with a third-degree felony of abandoning a child without intent to return. At the time, she was given a bond of $90,000.
Here’s what happened
According to police, Cux-Ajtzalam allegedly gave birth to a baby on the ground behind a food truck where she was working in the 6020 block of Dashwood Drive.
After giving birth, court records state that the teenager tied the baby, placenta, and umbilical cord into a trash bag before placing it inside a nearby dumpster, leaving the baby behind.
Records show that a passerby heard the baby crying for help and called 911 to recover the child. The baby was transported to the hospital where its condition remains unknown.
When officers caught up with Cux-Ajtzalam, she allegedly told them that she had no other choice than to throw her baby away because she didn’t want her boyfriend to break up with her.
Additionally, investigators said the entire incident was caught on surveillance video.
Cux-Ajtzalam is said to be a flight risk, having no ties to the country.
Copyright 2024 by KPRC Click2Houston - All rights reserved.
Christian terry.
Christian Terry covered digital news in Tyler and Wichita Falls before returning to the Houston area where he grew up. He is passionate about weather and the outdoors and often spends his days off on the water fishing.
Accra, Aug. 1, GNA – Ghana has made tremendous progress in reducing neonatal mortality rates from 29 deaths per 1,000 Live Births (LB) in 2014, to 17 per 1,000 LB in 2023.
This shows commitment towards improving newborn health using a separate national health strategy.
Presently, the Ministry of Health’s sector indicator prioritises neonatal mortality rate and newborn health in the National Committee Strategy, and it is listed among priority sectors of the country’s Universal Health Coverage roadmap.
To achieve optimum impact, some guidelines, manuals, and documents has been produced and there is now improvement in accountability for the newborns, through monitoring of institutional care using data and holding annual conferences to deliberate on progress made, as well as to consider the way forward.
To ensure these, the Ghana Health Service (GHS) in collaboration with key development partners, has held the 12th Annual Newborn Stakeholders’ Conference on the theme: “Improving respiratory care for the newborn within the Network of Practice”.
Dr Marion Okoh-Owusu, the Director of Family Health, GHS said the conference aimed to update key policy makers, health managers, frontline workers, development partners and key stakeholders on the current state of newborn health in Ghana, review strategies and protocols for improving respiratory care for newborns along the continuum of care and take stock of implementation of Regional and National Newborn Action plans.
It would also develop annual National and Regional plans for implementing Newborn programmes in line with the Reproductive, Maternal, Newborn, Child, and Adolescent Health Nutrition (RMNACHN) Strategy, and the National Newborn Health Strategy and Action Plan for August 2024 to July 2025.
Dr Edward Antwi, the Deputy Director of Public Health, Family Health Division, GHS, made a presentation on the state of Ghana’s newborn health, saying, although there had been considerable progress in reducing neonatal mortality, there was still more work to be done, to further reduce the rate of neonatal deaths to 12 per 1,000 LB by the year 2030, through preventive strategies.
He said the first 28 days of life (neonatal period) was crucial for infant survival and ensuring their quality of life, as about 68 per cent of deaths occurred during such periods, with 47 per cent others dying before age five years.
He mentioned the common causes of neonatal mortality and morbidity as prematurity, infections, and birth asphyxia (lack of oxygen and blood flow to the brain) which, depending on the severity, a baby could fully recover or suffer permanent brain and organ damage which could be fatal.
Dr Antwi said challenges including poor access, funding, limited human resources in terms of knowledge and skills in newborn care, as well as infrastructure deficit, were some concerns for urgent redress to enhance newborn safety, survival improve the quality of life of children under five years.
He said the National Newborn Health Strategy was currently being reviewed to extend 2025, with targets including achieving high infection prevention and treatment among newborns and children under five years old.
Dr Patrick Kuma-Aboagye, the Director-General, GHS, in a speech read for him, called for enhanced stakeholder collaboration and sustained efforts to attain Ghana’s Sustainable Development Goals targets of minimising infections and investing in newborn care in all facilities nationwide.
Dr Bernard Okoe Boye, the Minister of Health, in a speech read for him, said although newborn care had been included in the national development plan and budget, it was not just a goal but also a moral imperative and called for collective efforts to address the challenged to achieve Ghana’s SDGs targets by 2030.
The USAID has also been supporting the establishment of oxygen infrastructure, providing feedback, training for neonatal nursing, and expanding their Network of Practice (NoP) and working towards strengthening Ghana’s referral systems.
Likewise, UNICEF has been working extremely hard to improve the quality of healthcare for all, especially newborns.
PATH and Kybele, both international health partners, said they had also been working together with GHS in providing training for healthcare workers to improve the quality in healthcare facilities that provided innovations in newborn transport, focusing on collecting accurate data so that the Service does not make decisions based on estimated data.
Tonix pharmaceuticals holding corp. (nasdaq: tnxp) (tonix or the company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announces a poster presentation at the american chemistry society (acs) spring 2024 meeting, held march 17-21, 2024, in new orleans, louisiana..
Four Phase 2 investigator-initiated studies of TNX-1900 (intranasal potentiated oxytocin) are ongoing for pediatric obesity, binge eating disorder, bone health in autism and social anxiety disorder
TNX-2900 (intranasal potentiated oxytocin) is being developed under an IND as a treatment for Prader-Willi Syndrome, an Orphan Disease characterized by excessive eating
TNX-1900 and TNX-2900 may serve as novel neuroendocrine treatments for certain pain, eating and endocrine disorders
CHATHAM, N.J., March 21, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announces a poster presentation at the American Chemistry Society (ACS) Spring 2024 Meeting, held March 17-21, 2024, in New Orleans, Louisiana. A copy of the poster is available under the scientific presentations page of the Tonix website at www.tonixpharma.com .
The poster presentation titled, Oxytocin Analogs with Enhanced Craniofacial Antinociceptive Effects in Low Magnesium Formulations, describes the discovery and characterization of novel oxytocin analogues that are candidate treatments for craniofacial pain, excessive eating (including Prader Willi Syndrome), and endocrinological conditions including bone health in autism and insulin resistance.
“Intranasal oxytocin has several potential therapeutic applications,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Preclinical studies have shown that oxytocin, a hypothalamic peptide hormone, simultaneously reduces food intake and increases energy expenditure, leading to weight loss. 1-3 Intranasal oxytocin is well-tolerated and in published studies of adults, results in reduced caloric intake, increased fat burning and improved insulin sensitivity. 1-3 ”
Dr. Lederman continued, “There is preclinical evidence that the activity of intranasal oxytocin is dependent on magnesium (Mg ++ ) concentration. 4-6 Our current intranasal oxytocin formulations of TNX-1900 and TNX-2900 contain Mg ++ to augment the activity. We believe the new oxytocin analogues described in the poster have enhanced binding to Mg ++ and consequently their activity does not require Mg ++ augmentation.”
Four Phase 2 investigator-initiated studies of TNX-1900 are currently ongoing; three at the Massachusetts General Hospital (MGH) and one at the University of Washington. The Phase 2 ‘POWER’ study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to induce weight loss and improve indicators of cardiometabolic risk in adolescent patients with obesity. The Phase 2 ‘STROBE’ study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to reduce binge eating frequency in adults with binge-eating disorder. The Department of Defense (DoD)-funded Phase 2 ‘BOX’ study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to improve bone health in children with autism spectrum disorder. In addition, a Phase 2 study at the University of Washington is investigating the potential role of TNX-1900 in enhancing vicarious extinction learning in social anxiety disorder, compared to healthy controls.
About TNX-1900 and TNX-2900
TNX-1900 and TNX-2900 (intranasal potentiated oxytocin) are proprietary formulations of oxytocin. TNX-1900 is in Phase 2 development under investigator-initiated INDs as a candidate for adolescent obesity, binge eating disorder, bone health in autism and social anxiety disorder. TNX-1900 is also planned for development in treating insulin resistance. TNX-2900 is in development as a treatment for Prader Willi Syndrome. TNX-2900 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and its IND has been cleared. In 2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Tonix’s patented intranasal potentiated oxytocin formulation intended for use by adults and adolescents. Tonix’s patented potentiated oxytocin formulation is believed to increase specificity for oxytocin receptors relative to vasopressin receptors as well as to enhance the potency of oxytocin. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin is believed to be more than 600 million years old and is present in vertebrates including mammals, birds, reptiles, amphibians and fish. 7 It was originally approved by the U.S. Food and Drug Administration as Pitocin ® *, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor. An intranasal formulation of oxytocin is marketed in some European countries to assist in the production of breast milk as Syntocinon ® ** (oxytocin nasal 40 units/ml). Oxytocin has no recognized addiction potential. Oxytocin, when delivered via the nasal route, concentrates in the trigeminal system 1 resulting in binding of oxytocin to receptors on neurons in the trigeminal system. With TNX-1900 and TNX-2900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding 8 as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models 9 . Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children 10 . Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.
About Prader-Willi Syndrome (PWS)
PWS is recognized as the most common genetic cause of life-threatening childhood obesity and affects males and females with equal frequency and all races and ethnicities. PWS results from the absence of expression of a group of genes on the paternally acquired chromosome 15. The hallmarks of PWS are lack of suckling in newborns and, in children and adolescents, severe hyperphagia, an overriding physiological drive to eat, leading to severe obesity and other complications associated with significant mortality. A systematic review of the morbidity and mortality as a consequence of hyperphagia in PWS found that the average age of death in PWS was 22.1 years. 11 There is no approved medication to treat poor feeding in newborns or hyperphagia in children and adolescents with PWS. Given these serious or life-threatening manifestations of these conditions, there is a critical need for effective treatments to decrease morbidity and mortality, improve quality of life, and increase life expectancy in people with PWS. Oxytocin has potent effects in adult mice correcting behavioral characteristics of the Magel2 knock-out mouse model for PWS and autism. 12 In addition, oxytocin has potent effects in correcting behavioral characteristics of the neonatal Magel2 knock-out mouse model for PWS and autism 13 and intriguing effects in a clinical trial of neonates with PWS. 14
*Pitocin ® is a trademark of Par Pharmaceutical, Inc.
**Syntocinon ® is a trademark of BGP Products Operations GmbH
1 Lawson EA, et al. J Neuroendocrinol 2020;32(4):e12805. doi: 10.1111/jne.12805. 2 Niu J, et al. Front Neurosci 2021;15:743546. doi: 10.3389/fnins.2021.743546. 3 Maejima Y, et al. Neuroendocrinology 2018;107(1):91-104. 4 Yeomans DC, et al. Transl Psychiatry . 2021. 11(1):388. 5 Tzabazis A, et al. Cephalalgia . 2016. 36(10):943-50. 6 Meyerowitz JG, et al. Nat Struct Mol Biol . 2022. 29(3):274-281. 7 Gruber CW. Exp Physiol. 2014. 99(1):55-61. doi: 10.1113/expphysiol.2013.072561. 8 Antoni FA and Chadio SE. Biochem J . 1989. 257(2):611-4. 9 Cai Q, et al., Psychiatry Clin Neurosci . 2018. 72(3):140-151. 10 Yeomans, DC et al. 2017. US patent US2017368095. 11 Bellis SA, et al. Eur J Med Genet . 2022. 65(1):104379. 12 Meziane H, et al. Biol Psychiatry . 2015. 78(2):85-94. 13 Bertoni A, et al. Mol Psychiatry . 2021. 26(12):7582-7595. 14 Tauber M, et al. Pediatrics . 2017. 139(2):e20162976.
Tonix Pharmaceuticals Holding Corp. *
Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace ® SymTouch ® (sumatriptan injection) 3 mg and Tosymra ® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com .
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Investor Contact Jessica Morris Tonix Pharmaceuticals [email protected] (862) 904-8182
Peter Vozzo ICR Westwicke [email protected] (443) 213-0505
Media Contact Ben Shannon ICR Westwicke [email protected] (919) 360-3039
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Background:.
Mortality associated with neonatal surgical emergencies is high, due to late presentation and delayed surgical intervention in developing countries. The aim of this study is to determine factors associated with poor outcome of neonatal surgical emergencies at a Federal Teaching Hospital Northeastern Nigeria.
A retrospective study of 85 neonates aged 1-28 days was carried between June 2019-May 2022. Records of the neonates with surgical emergencies were retrieved and analyzed with the SPSS Version 20.
A total of 85 neonates, 55 (64.8%) males and 30(35.3%) females were analyzed. The average duration of symptoms at presentation is about 5.3-day range 1-10days. About 51(60.0%) neonates presented after 24 hours of life 34(40.0%) within 24 hours of life, out of which were 12(35.3%) neonates with gastroschisis presenting after 8hours with severe hypothermia axillary temperature of 32.1o Celsius. The 46 (90.2%) neonates presenting after 24hours of life had travelled distances of 50-100Kms to get to the hospital, out of which about 31(67.4%) arriving the following day, with about 9(29.0%) who had gastroschisis noticed to be lifeless at presentation. Overall, about 26(30.6%) died due to late presentation, delayed surgical intervention and lack radiant warmers.
Late presentation delayed surgical intervention are common causes of mortality in neonates with surgical emergencies in Gombe
The last 60 years has witnessed a tremendous improvement in outcome of treatment of neonatal surgical emergencies in the developed world due to availability of specialist surgical care, early presentation and intervention, improved anaesthetic care and diagnostic facilities. 1 Unlike in developing countries where the outcome is still poor due to non-availability of resources and untrained manpower. 2 The ability to provide timely and effective surgical care to newborns in these settings is crucial not only for immediate survival but also for long-term health and well-being. Even though progress has been made over the years in our region as in the study by Ekwunife et al ., 3 there seems to be more work to be done. The Federal Teaching Hospital, Gombe is the only tertiary healthcare facility in this region, saddled with the complex task of managing neonatal surgical cases. This underscores the importance of reviewing our experience with the management of neonatal surgical cases. Our aim therefore is to determine preoperative factors associated with poor outcome of treatment of neonatal surgical emergencies at Federal Teaching Hospital, Gombe in Northeastern Nigeria.
Retrospective data of neonates aged 1-28 days presenting to Federal Teaching Hospital, Gombe with surgical emergencies was analyzed between June 2019 and May 2020.
Data analyzed were distances travelled to reach the hospital by patients’ address, duration of symptoms, reason for delay intervention, and outcome. Neonates with orthopaedic surgical emergencies were exclude from this review. Data were analyzed using simple descriptive analysis.
Teaching Hospital Gombe is the only tertiary health facility in the state of a population of 2,398,957 people according to NBS 4 . Patients are received from all the 11 local government areas and the neighboring state villages. The Paediatric Surgery unit was established in 2011 and has a bed capacity for 30 spaces. All neonates come through the Special Baby Care unit irrespective of pathology before paediatric surgeons are called to review.
There were 96 neonates, but records of only 85 (88.5%) neonates, 55 (64.8%) males and 30 (35.3%) females, ratio of 1.9:1 M: F were available for analysis.
About 29 (34.1%) neonates had anorectal malformations, 23 (27.1%) gastroschisis, 17 (20.0%) omphaloceles, 8 (9.4%) Hirschsprung’s diseases, 4 (4.7%) intestinal atresias and 2 (2.4%) intestinal malrotations 2 (2.4%). Average duration of symptoms before presentation is about 5.3-days, range 1-10days. Mots (60.0%) neonates presented after 24 hours of life, the rest 34 (40.0%) within 24 hours. In terms of distances travelled, 46 (90.2%) had travelled distances of 50-100Kms to reach the hospital, with 31 (67.4%) of them arriving a day after. Nine (29.0%) of them who had gastroschisis wrapped in dirty clothes already death at presentation.
Surgical intervention was delayed in 19 (22.4%) by 8-72 hours partly due to delay in inviting paediatric surgeons, in getting investigation results, in getting blood, in buying intravenous fluids and antibiotics, in signing consent for surgery, to control sepsis, fluid and electrolyte deficits and acute renal failure. Seven (36.8%) neonates died for severe dehydrations and sepsis before they could be resuscitated for surgery.
Overall, 47 (55.3%) neonates were operated after 24 hours of presentation and 22 (25.9%) neonates within 24 hours of presentation, As shown on Table 1 .
Depicting intervention time and outcome
Interventions N (%) | Time of intervention | Outcome after surgical interventions |
---|---|---|
Silo application for 12(54.5) | 8 hours of admission | 5 died of sepsis, hypothermia & malnutrition |
Colostomy 5(22.7) | 19 hours of admission | |
Anoplasty 3(13.6) | 13 hours of admission | |
Closure of ruptured Omphalocele major in 2(9.1) | 6 hours of admission | All died of hypothermia |
Colostomy 27(57.4) | 2-5th day of admission | |
Silo application 2(4.3) | 2nd day of admission | All died of sepsis and hypothermia |
Debridement of septic omphalocele sac 13(27.7) | 8-10th day of admission | |
Ileoileal anastomosis 3(6.4) | 2-3days of admission | 1 died of sepsis with acute renal failure |
Ladd's procedure 2(4.3) | 2nd day of admission |
There was an overall mortality of 26 (30.6%) due to sepsis, malnutrition and hypothermia. Out of this, about 10 (38.5%) neonates died within 6-12 hours after surgery from hypothermia. Reasons for this early post operative death was due to the fact that hypothermia were limited radiant warmer, non-functioning incubators and power failure.
This three-year retrospective review shows that neonatal surgical mortality in Gombe Federal Teaching Hospital is in accordance with other reports in Nigeria and other African countries. We had an overall mortality rate of 30.6%. The overall neonatal mortality rate of 30.6% observed in this report is in accordance with other reports in Nigeria. Yola et al . 6 had a mortality rate of 16.9% in Kano, Iniabasi et al . 5 reported a mortality rate of 62.2% in Uyo Teaching Hospitals in Nigeria. Across Africa, mortality rates of 24% and 43.1% have been associated with neonatal surgical emergencies in Kenya and Cameroon, respectively. 7 , 8 , 9
Our study identified late presentation, delayed surgical intervention, and limited or lack of facilities as determinants of poor outcome in neonates with surgical emergencies. Similar findings have been reported by others. Abubakar et al . 10 reported a mortality rate of 33.3% associated with late presentation, comparable to our finding of 36.8%. Other reports documented mortality rates of 60.7%-72.7% due to delayed surgical intervention, often because parents delayed consent due to financial reasons. 11 , 12 , 13 Delay in acquiring resuscitation items, possibly due to financial constraints, also contributed to delayed surgical intervention in our study.
Furthermore, we observed a mortality rate of 29.0% due to late presentation in neonates with gastroschisis, resulting in death after traveling long distances to reach the hospital, possibly due to sepsis, hypothermia, hypotension, or hypoglycemia. Osifo et al . 17 reported a 65.5% mortality rate in neonatal surgical emergencies associated with delayed presentation, with 7.5% of these neonates too ill upon arrival to be resuscitated.
There was higher mortality among patients with anterior abdominal wall defects, potentially attributable to hypothermia or hypotension ( Table 1 ). More mortality was observed in patients with omphalocele, possibly due to underlying metabolic or cardiac anomalies that were not identified in our study.
We attribute late presentation in about 68.5% of our patients presenting beyond 24 hours to lack of transport infrastructure. Efficient transport is crucial as journeys of 50-100 km in a day are challenging without it. Other reasons for late presentation could be lack of funds, ignorance, and reliance on family members proficient in communication to accompany them to the hospital. This communication barrier was noted in our study and others. 18 - 22 To address this, the hospital has introduced community liaison personnel or hospital interpreters to facilitate communication, improving early hospital presentation by about 40%, according to some reports. 23 - 25
The overall mortality rate of 30.6% can be reduced by investing in improved equipment in our setup. In this report, lack of radiant warmers, incubators, and frequent power outages resulted in 38.5% of neonates dying of hypothermia within 12 hours of surgery, highlighting the urgent need for infrastructure development in the neonatal unit of the hospital.
The determinants of poor neonatal surgical emergencies in Gombe are late presentation, delayed surgical intervention and limited resources. Hence, management of a neonatal surgical emergencies could be a serious challenge because such factors play a significant role. But with public education and government intervention programs in providing free ambulance transportation services and equipment much mortality can lead to a reduction in the management of our neonatal surgical emergencies.
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