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

NCT ID: NCT06502847

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

338 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-06-01

Brief Summary

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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

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Conditions

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Neonatal Jaundice From Other Specified Causes ABO Incompatibility ABO Hemolytic Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case ABO1

Newborns who receive treatment due to the ABO Incompability will be included in this group.

Exosome profile study

Intervention Type OTHER

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.

Exosome profile study

Intervention Type OTHER

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

Exosome profile study

Intervention Type OTHER

Neonatal serum and maternal exosome profiles will be studied in all groups.

Interventions

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Exosome profile study

Neonatal serum and maternal exosome profiles will be studied in all groups.

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seda Yilmaz Semerci

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Health Sciences Istanbul KSS Training and Research Hospital

Istanbul, Kucukcekmece, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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43057

Identifier Type: -

Identifier Source: org_study_id

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