The Role of Breastmilk and Serum Exosome Profile in Prediction of the Severity and Treatment Requirement of Neonatal Jaundice Due to ABO Incompatibility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Number of the participant who Need for Treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Lack of informed consent
- •Congenital abnormalities
- •Maternal Liver diseases
- •Neonatal liver diseases
- •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
结局指标
主要结局
Number of the participant who Need for Treatment
时间窗: 12 months
Association between the serum and breastmilk exosome and need for treatment due to ABO incompability
次要结局
未报告次要终点
研究者
Seda Yilmaz Semerci
Assoc Prof
Health Institutes of Turkey