Liver Biopsy in Diagnosis Neonatal Jaundice

NCT06628726 | Not Yet Recruiting DMC

• 1 other identifier: biopsy role neonatal jaundice
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Neonatal Cholestasis; Neonatal Jaundice

Keywords

liver biopsy in neonatal jaundice; Neonatal Cholestasis; liver biopsy

Outcome Measures

Primary Outcomes (1)

• Identification of the key histopathological features in liver biopsy

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

  baseline

Secondary Outcomes (1)

• Evaluation of significance of liver biopsy as a diagnostic tool

  baseline

Study Arms (1)

Neonates

EXPERIMENTAL

Neonates with persistent neonatal jaundice underwent liver biopsy

Diagnostic Test: Liver biopsy

Interventions

Liver biopsy DIAGNOSTIC_TEST

surgical biopsy from liver

Also known as: Liver wedge biopsy, Liver core biopsy, Liver incisional biopsy

Neonates

Eligibility Criteria

• Age: 1 Month - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Mansour E, Eissa AN, Nofal LM, Kharboush I, Reda AA. Morbidity and mortality of low-birth-weight infants in Egypt. East Mediterr Health J. 2005 Jul;11(4):723-31.

  PMID: 16700389 BACKGROUND

• Fawaz R, Baumann U, Ekong U, Fischler B, Hadzic N, Mack CL, McLin VA, Molleston JP, Neimark E, Ng VL, Karpen SJ. Guideline for the Evaluation of Cholestatic Jaundice in Infants: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):154-168. doi: 10.1097/MPG.0000000000001334.

  PMID: 27429428 BACKGROUND

• Ali KM, Zalata KR, Barakat T, Elzeiny SM. Pathologic approach to Neonatal cholestasis with a simple scoring system for biliary atresia. Virchows Arch. 2024 Jan;484(1):93-102. doi: 10.1007/s00428-023-03704-5. Epub 2023 Nov 27.

  PMID: 38008855 BACKGROUND

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Moemen M Hafez, M.D.

  Faculty of Medicine, Assiut University, Assiut, Egypt

  STUDY DIRECTOR

• Abeer M Refaiy, M.D.

  Faculty of Medicine, Assiut University, Assiut, Egypt

  STUDY DIRECTOR

Central Study Contacts

Nourhan H Fouad, MBBCh

CONTACT

+201229788587; nourhannasr97@aun.edu.eg

Abeer M Refaiy, M.D.

CONTACT

+20118449977; abeer_refaiy@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10