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Liver Biopsy in Diagnosis Neonatal Jaundice

Role of Liver Biopsy As a Diagnostic Tool for Neonatal Jaundice Causes

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06628726
Enrollment
50
Registered
2024-10-08
Start date
2024-11-01
Completion date
2025-12-31
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Cholestasis, Neonatal Jaundice

Keywords

liver biopsy in neonatal jaundice, Neonatal Cholestasis, liver biopsy

Brief summary

1. Identification and characterization of histopathological features of liver in cases of PNJ. 2. Assessment of key histological features in liver biopsy as diagnostic parameters in differentiating intra-hepatic and extra-hepatic causes of PNJ. 3. Evaluation of role of liver biopsy as a diagnostic tool in conjunction with clinical and laboratory findings.

Detailed description

Neonatal cholestasis (NC) is described as an early-life defect in bile production or flow that causes the liver to retain biliary substances. Persistent Neonatal Jaundice (PNJ) is the presence of variable degrees of jaundice, choluria and hypocholic or acholic stools for more than 10 days during early months of life. The rate of neonatal cholestasis is estimated to be 1 per 2,500 live births worldwide. In Egypt, about 20.4% of full-term newborns develop jaundice yearly. Extrahepatic cholestasis(EHC) and intrahepatic cholestasis(IHC) are the two main causes of persistent neonatal jaundice. This division is according to the presence or absence of extrahepatic obstruction to bile flow. Biliary atresia(BA) and idiopathic neonatal hepatitis(INH) are the most frequent etiologies for EHC and IHC respectively. It is critical to identify the underlying cause of PNJ in order to start the right surgical or medicinal treatment. Early surgical referral is necessary in biliary atresia(BA) to increase success rates. In the case of treatable metabolic diseases, a prompt diagnosis justifies prompt, targeted therapy and a better prognosis. Despite the development of new diagnostic means and advances in imaging techniques, non-invasive biomarkers and genomic studies, a liver biopsy done at the right time is still an important tool to evaluate and diagnose patients with cholestasis, as it will help to decide the etiology, the prognosis and eventually the treatment of the patient. The evaluation of liver biopsies in infantile cholestasis disorders is crucial as the histologic features of many of these disorders may overlap and vary with age.

Interventions

DIAGNOSTIC_TESTLiver biopsy

surgical biopsy from liver

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 1 Years
Healthy volunteers
No

Inclusion criteria

* All cases presented with persistent neonatal jaundice in the first year of life in 5 years interval (2019-2023), received at Surgical Pathology Laboratory at Assiut University Hospitals, Egypt.

Exclusion criteria

* Patients older than one year. * Patients who underwent liver biopsy in the same age group but were not diagnosed as Persistent Neonatal Jaundice. * Patients with deficient clinical data.

Design outcomes

Primary

MeasureTime frameDescription
Identification of the key histopathological features in liver biopsybaselineIdentification of the key histopathological features in liver biopsy that aid in differentiation intra-hepatic and extra-hepatic causes of persistent neonatal jaundice (PNJ).

Secondary

MeasureTime frameDescription
Evaluation of significance of liver biopsy as a diagnostic toolbaselineEvaluation of significance of liver biopsy as a diagnostic tool with clinical and laboratory findings in detection of persistent neonatal jaundice (PNJ) causes.

Contacts

Primary ContactNourhan H Fouad, MBBCh
nourhannasr97@aun.edu.eg+201229788587
Backup ContactAbeer M Refaiy, M.D.
abeer_refaiy@aun.edu.eg+20118449977

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026