Persistent Neonatal Jaundice on Neonates and Childern

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06080971
Collaborator
(none)
100
17.6

Study Details

Study Description

Brief 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 .

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    A Descriptive Study on Patterns of Persistent Neonatal Jaundice on Neonates and Children at Assiut University Children Hospital
    Anticipated Study Start Date :
    Oct 13, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Mar 31, 2025

    Outcome Measures

    Primary Outcome Measures

    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 . [Baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Days to 18 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Elham Allam Ahmed Abd elkarim, 71515,Assiut, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06080971
    Other Study ID Numbers:
    • persistent neonatal jaundice
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 16, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 16, 2023