The Role of Breastmilk and Serum Exosomes in Neonatal Jaundice Due to ABO Incompatibility

Completed

• Conditions: ABO Hemolytic Disease; Neonatal Jaundice From Other Specified Causes; ABO Incompatibility

• Registration Number: NCT06502847
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

Neonatal jaundice is a major global health issue that can lead to serious complications and even death if not promptly treated. ABO incompatibility is a common cause of pathological neonatal jaundice, but there are currently no specific tests to predict its severity or progression. This project aims to study the role of exosomes in the diagnosis and treatment of newborn jaundice, focusing on their impact on infants with ABO incompatibility. The study will take place at a reference neonatal intensive care unit, involving 45 infants. Serum and breast milk samples will be collected and analyzed to determine any relationships and possible correlations.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-16
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

• Newborns who are needed treatment for neonatal jaundice due to ABO incompatibility
• Newborns who are admitted to the study center due to ABO hemolytic disease
• Newborns with ABO incompatibility
• Healthy newborns
• Healthy mothers

Exclusion Criteria

• Lack of informed consent
• Congenital abnormalities
• Maternal Liver diseases
• Neonatal liver diseases
• Sepsis
• Neonatal jaundice due to the causes other than ABO incompatibility
• Acute or chronic disease state in newborn
• Maternal acute or chronic disease
• Medication or substance use effecting liver functions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of the participant who Need for Treatment	12 months	Association between the serum and breastmilk exosome and need for treatment due to ABO incompability

Trial Locations

Locations (1)

University of Health Sciences Istanbul KSS Training and Research Hospital; 🇹🇷 Istanbul, Kucukcekmece, Turkey