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

July 15, 2025 updated by: Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital

The Role of Breastmilk and Serum Exosome Profile in Prediction of the Severity and Treatment Requirement of Neonatal Jaundice Due to ABO Incompatibility

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

338

Contacts and Locations

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

Study Locations

  • Turkey
    • Kucukcekmece
      • Istanbul, Kucukcekmece, Turkey, 34303
        • University of Health Sciences Istanbul KSS Training and Research Hospital

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

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

It is planned to include a total of 45 babies in the study, including healthy babies (n=15) in the first group, babies who developed jaundice due to ABO incompatibility but did not need treatment (n=15) in the second group, and babies who developed jaundice due to ABO incompatibility and needed treatment (n=15) in the third group.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case ABO1
Newborns who receive treatment due to the ABO Incompability will be included in this group.
Other: Exosome profile study
Neonatal serum and maternal exosome profiles will be studied in all groups.
Case ABO2
Newborns who have the ABO Incompability, but do not require treatment will be included in this group.
Other: Exosome profile study
Neonatal serum and maternal exosome profiles will be studied in all groups.
Control
Healthy newborns without any disease or health condition will be included in this group
Other: Exosome profile study
Neonatal serum and maternal exosome profiles will be studied in all groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of the participant who Need for Treatment
Time Frame: 12 months
Association between the serum and breastmilk exosome and need for treatment due to ABO incompability
12 months

Collaborators and Investigators

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

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

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 (Actual)

July 1, 2020

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on ABO Incompatibility

Clinical Trials on Exosome profile study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe