Persistent Neonatal Jaundice on Neonates and Childern

October 12, 2023 updated by: Elham Allam Ahmed Abd elkarim, Assiut University

A Descriptive Study on Patterns of Persistent Neonatal Jaundice on Neonates and Children at Assiut University Children Hospital

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 .

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

neonates and children with prolonged neonatal jaundice

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
Time Frame: Baseline
Describe the distribution of etiologies of (PNNG) in neonates & children at AUCH.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 13, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • persistent neonatal jaundice

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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