The Role of Breastmilk and Serum Exosomes in Neonatal Jaundice Due to ABO Incompatibility
1 other identifier
observational
338
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 9, 2024
CompletedFirst Posted
Study publicly available on registry
July 16, 2024
CompletedJuly 18, 2025
July 1, 2025
2.9 years
July 9, 2024
July 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of the participant who Need for Treatment
Association between the serum and breastmilk exosome and need for treatment due to ABO incompability
12 months
Study Arms (3)
Case ABO1
Newborns who receive treatment due to the ABO Incompability will be included in this group.
Case ABO2
Newborns who have the ABO Incompability, but do not require treatment will be included in this group.
Control
Healthy newborns without any disease or health condition will be included in this group
Interventions
Neonatal serum and maternal exosome profiles will be studied in all groups.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Health Sciences Istanbul KSS Training and Research Hospital
Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc Prof
Study Record Dates
First Submitted
July 9, 2024
First Posted
July 16, 2024
Study Start
July 1, 2020
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
July 18, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share