Initiation of Resuscitative Care While on Placental Circulation for Infants With Congenital Diaphragmatic Hernia - a Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Proportion of infants with hypotension requiring inotropes
研究概览
简要总结
This study aims to measure the cardio-respiratory physiological consequences of initiating resuscitation during placental transfusion (PT) with an intact umbilical cord in infants with congenital diaphragmatic hernia (CDH). PT, mainly via delayed cord clamping, has been shown to offer a higher circulating blood volume, less need for blood transfusion, less need for inotropes in infants.
Currently infants with CDH receive immediate cord clamping (ICC) to facilitate immediate resuscitation including immediate intubation and mechanical ventilation.
With the development of a resuscitation platform (iNSPiRE), resuscitative care can now be commenced from birth in infants with CDH to benefit from PT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 10 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infants with an antenatal diagnosed CDH.
排除标准
- •Severe antepartum or postpartum hemorrhage.
- •Any obstetrical concern.
- •Lack of parental consent.
研究组 & 干预措施
Ventilatory support while attached to the cord
Infants will receive active resuscitative care (intubation and ventilation) using a specific designed platform for 120 seconds during delayed cord clamping. Then the cord will be clamped forgoing resuscitation care.
干预措施: Ventilatory support while attached to the cord (Procedure)
Immediate cord clamping
Infants will receive immediate cord clamping, transferred to the resuscitation table, intubated and mechanical ventilated according to our current Congenital Diaphragm Hernia protocol.
干预措施: Immediate cord clamping (Procedure)
结局指标
主要结局
Proportion of infants with hypotension requiring inotropes
时间窗: first 24 hours after birth
Proportion of infants with hypotension requiring inotropes in the first 24 hours after birth in the neonatal intensive care unit.
次要结局
未报告次要终点