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

Kanuni Sultan Suleyman Training and Research Hospital

Status: Not yet enrolling

Conditions: ABO Hemolytic Disease; Neonatal Jaundice From Other Specified Causes; ABO Incompatibility

Treatments: Other: Exosome profile study

Study type: Observational

Funder types: Other

Identifiers

NCT06502847

43057

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 3 patient groups

Case ABO1

Description:

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

Treatment:

Other: Exosome profile study

Case ABO2

Description:

Newborns who have the ABO Incompability, but do not require treatment will be included in this group.

Treatment:

Other: Exosome profile study

Control

Description:

Healthy newborns without any disease or health condition will be included in this group

Treatment:

Other: Exosome profile study