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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06502847
Enrollment
338
Registered
2024-07-16
Start date
2020-07-01
Completion date
2023-06-01
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ABO Hemolytic Disease, ABO Incompatibility, Neonatal Jaundice From Other Specified Causes

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.

Interventions

OTHERExosome profile study

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

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days

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

Design outcomes

Primary

MeasureTime frameDescription
Number of the participant who Need for Treatment12 monthsAssociation between the serum and breastmilk exosome and need for treatment due to ABO incompability

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026