NCT03741803已完成不适用
Randomized Controlled Trial to Evaluate the Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年11月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Neonatal bilirubin level
研究概览
简要总结
The purpose of the study is to determine if neonates (who already have an increased risk of hyperbilirubinemia due to mother's history of having previous neonate who received phototherapy for hyperbilirubinemia) have higher bilirubin levels 24 hours after birth with delayed cord clamping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •mothers delivering at 35 weeks or greater
- •mothers who have had at least 1 previous child that received phototherapy for hyperbilirubinemia
- •multiple gestations can be included unless the neonate does not meet criteria for delayed cord clamping as described below or due to concerns about safety of delayed cord clamping for timing of delivery of the 2nd twin (ie: 2nd twin requires immediate delivery intervention)
排除标准
- •- Neonates who do not meet criteria for delayed cord clamping (any infant that any provider in the room felt needed evaluation by the neonatal transport team immediately so that the infant would be handed off for resuscitation. If the patient required delivery by cesarean section the delayed cord clamping protocol would be abandoned).
研究组 & 干预措施
Delayed cord clamping
Active Comparator
干预措施: Delayed cord clamping (Procedure)
Early cord clamping
Active Comparator
干预措施: Early cord clamping (Procedure)
结局指标
主要结局
Neonatal bilirubin level
时间窗: 24 hours after birth
次要结局
- Number of neonates with a need for phototherapy(From birth to up to 1 week after birth)
- Number of neonates with a need for exchange transfusion(From birth to up to 1 week after birth)
- Number of neonates re-hospitalized for jaundice(From birth to up to 1 week after birth)
- Number of neonates admitted to the neonatal intensive care unit (NICU)(From birth to up to 1 week after birth)
- Number of neonates with hyperbilirubinemia(24 hours after birth)
- Number of mothers with postpartum hemorrhage(From birth to up to 1 week after birth)
研究者
Pamela Berens
Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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