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Completed

NCT Number: NCT06502847

The Role of Breastmilk and Serum Exosomes in 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.

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Key information

Conditions

Neonatal Jaundice From Other Specified Causes ABO Hemolytic Disease ABO Incompatibility

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences Istanbul KSS Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exosome profile study

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 16, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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