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Not yet recruitingNCT06080971Updated Oct 16, 2023

Persistent Neonatal Jaundice on Neonates and Childern

An observational study in Neonatal Jaundice, sponsored by Assiut University. Not yet recruiting. Open to participants aged 14 Days to 18 Years. Per ClinicalTrials.gov, last updated 2023-10-16.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
14 Days to 18 Years
Sex
All
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Study summary

Describe demographic and clinical data of neonates \& childern with (PNNJ) admitted to neonatology , hepatology \& hematology units of Assiut university children hospital(AUCH).

Describe the distribution of etiologies of (PNNG) in neonates \& children at AUCH.

Assess the outcome of (PNNJ) in neonates \& childern admitted to AUCH .

Read the detailed description

(persistent ) Prolonged neonatal jaundice (PNNJ)is defined as a serum bilirubin level higher than 85 μ mol/L (5 mg/dl) with yellowish discoloration of the skin ,sclera and conjunctiva , which persists at postnatal 14 days in full term infants and 21 days following the birth in preterm infants .

Etiologically it is important to distinguish jaundice type , is it unconjugated (indirect) or conjugated (direct)hyperbilirubinemia. A prolonged unconjugated hyperbilirubinemia is mostly caused by breastfeeding(which is the most common identified cause for prolonged unconjugated hyperbilirubinemia , It is known that breastmilk jaundice is seen at a rate of 1.3% in newborn infants and 2.4-25% in infants fed with breastmilk ) or to some pathological conditions such as hemolytic diseases (due to hereditary spherocytosis ,elliptocytosis or G6PD deficiency), congenital hypothyroidism, urinary infection, Crigler-Najjar or Gilbert syndromes ,pyloric stenosis ,sepsis.

Conjugated hyperbilirubinemia (Cholestatic jaundice ) is never physiologic. It affects 1/2,500 live births and it should be suspected in all jaundiced infants with light stools and dark urine , The differential diagnosis of cholestasis is extensive and a step-wise approach based on the initial history and physical examination is useful to rapidly identify the underlying etiology, Early recognition of neonatal cholestasis is essential to ensure timely treatment and optimal prognosis. (causes Include infections, anatomic abnormalities of the biliary system, endocrinopathies, genetic disorders ,cystic fibrosis, metabolic abnormalities, toxin and drug exposures, vascular abnormalities, neoplastic processes, and other miscellaneous causes , the most commonly identifiable causes are biliary atresia (BA) (25%-35%), genetic disorders (25%), metabolic diseases (20%), and a1-antitrypsin (A1AT) deficiency (10%) ; other pathological causes of prolonged conjugated hyperbilirubinemia are TORCH-S infections, Neonatal hepatitis syndrome, Choledochal cyst , Inspissated bile syndrome, Galactosemia ,Alagille syndrome \& Hereditary bile acid synthesis disorders.

Diagnosis : is made according to the physical examination(skin ,stool \& urine color, organomegaly) , clinical presentation , investigations \&imaging findings.

The clinical presentation of(PNNJ) include yellowish discoloration of skin ,sclera \&conjunctiva with change in color of stool \&urine with or without organomegally persistent for more than 14 days in full term infants \&21 days in preterm infants.

investigations: include CBC, serum total \&direct Bilirubin , urine analysis \&culture , Coombs' test, thyroid function tests, G6PD level, LFT, blood film, GAL1PUT, alpha - 1 antitrypsin test , screening for TORCH ,Ultrasonography of the abdomen.

Investigations for cholestatic jaundice :fine needle or true cut needle liver biopsy , magnetic resonance cholangiopacreatography (MRCP),endoscopic retrograde cholangiopancreatography (ERCP) and hepatobiliary scintigraphy.

Mortality/morbidity:

  • Kernicterus or bilirubin encephalopathy, typically in infants It occurs when the unconjugated bilirubin levels cross 25 mg/dL in the blood it gets deposited in the brain tissue. The neurotoxicity leads to various neurologic sequelae as poor feeding ,irritability, a high-pitched cry ,no startle reflex ,lethargy , apnea , seizures ,cerebral palsy ,hearing loss ,learning disabilities.
  • Liver cell failure \&cirrhosis with portal hypertension are complications of neonatal cholestasis.

Treatment Phototherapy, intravenous immune globulin (IVIG), and exchange transfusion are the most widely used therapeutic modalities in certain instance as Gilbert syndrome medications as Phenobarbital an inducer of hepatic bilirubin metabolism a new therapy currently under development consist of inhibition of bilirubin production through blockage of heme oxygenase by using mesoporphyrins \& protoporphyins .

Treatment of Cholestatic jaundice depend mainly on cause of cholestasis ,all neonates \& children should receive fat soluble vitamins (A,K,E,D),surgical intervention (kasai procedure)or even liver transplantation may be done.

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Conditions studied

  • Neonatal Jaundice

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03

In context

Jaundice, Neonatal

110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.

This study's planned enrollment of 100 is below the median of 405 across 27 observational studies indexed under Jaundice, Neonatal.

Browse Jaundice, Neonatal studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Days to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

neonates and children with prolonged neonatal jaundice

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All neonates and children with prolonged neonatal jaundice admitted to Neonatology , hepatology \& hematology units at Assiut university children hospital through the period from 1/1/2024 to 31/12/2024.

Exclusion criteria

Exclusion Criteria:

  • Neonates with neonatal jaundice lasts less than 14 days in full term and 21 days in preterm infants
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Describe demographic and clinical data of neonates & childern with (PNNJ) admitted to neonatology , hepatology & hematology units of Assiut university children hospital(AUCH) Assess the outcome of (PNNJ) in neonates & childern admitted to AUCH .

    Describe the distribution of etiologies of (PNNG) in neonates \& children at AUCH.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Siu SL, Chan LW, Kwong AN. Clinical and biochemical characteristics of infants with prolonged neonatal jaundice. Hong Kong Med J. 2018 Jun;24(3):270-276. doi: 10.12809/hkmj176990. Epub 2018 May 25. PubMed 29807952 ↗
  • Feldman AG, Sokol RJ. Neonatal Cholestasis. Neoreviews. 2013 Feb 1;14(2):10.1542/neo.14-2-e63. doi: 10.1542/neo.14-2-e63. PubMed 24244109 ↗
  • Moyer V, Freese DK, Whitington PF, Olson AD, Brewer F, Colletti RB, Heyman MB; North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. Guideline for the evaluation of cholestatic jaundice in infants: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2004 Aug;39(2):115-28. doi: 10.1097/00005176-200408000-00001. Erratum In: J Pediatr Gastroenterol Nutr. 2004 Sep;39(3):306. PubMed 15269615 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2023; primary completion for Dec 2024, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2023
First posted
Oct 12, 2023
StartEst.
Oct 13, 2023
Primary completionEst.
Dec 31, 2024
CompletionEst.
Mar 31, 2025
Last update
Oct 16, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06080971
Lead sponsor
Assiut University
Responsible party
Elham Allam Ahmed Abd elkarim (71515,Assiut, Assiut University) — Principal investigator
First posted
Oct 12, 2023
Start date
Oct 13, 2023 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Oct 16, 2023

Study contacts

Elham Allam Ahmed
Contact
elhamallam4111@gmail.com
01025435054
yasser farouk, professor
Contact
yasser.rezk@med.aun.edu.eg
01111168123

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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