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

Not yet recruiting

• Conditions: ABO Hemolytic Disease; Neonatal Jaundice From Other Specified Causes; ABO Incompatibility
• Interventions: Other: Exosome profile study

• Registration Number: NCT06502847
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-15
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-17
• Study Start: 2024-08-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Exosome profile study	Healthy newborns without any disease or health condition will be included in this group
Case ABO1	Exosome profile study	Newborns who receive treatment due to the ABO Incompability will be included in this group.
Case ABO2	Exosome profile study	Newborns who have the ABO Incompability, but do not require treatment will be included in this group.

Primary Outcome Measures

Name	Time	Method
Number of the participant who Need for Treatment	12 months	Association between the serum and breastmilk exosome and need for treatment due to ABO incompability