Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease - INSPIRE-CHD
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Increase in heart rate
研究概览
简要总结
Before birth, the placenta (a structure with many blood vessels attached to the inside of your womb) and the umbilical cord (the umbilical cord is attached to the placenta) are sending oxygen and nutrients from the mother's blood through the umbilical cord to the baby. After a baby is born the cord is clamped and babies have to start breathing and support themselves.
At the moment when a baby with congenital heart disease is born they will have their cord clamped immediately (this is called immediate cord clamping (ICC)). After ICC the clinical team will start to help a baby transition by carefully monitoring their oxygen saturation (give oxygen if needed), provide warmth, and dry and stimulate. Several animal studies have shown that clamping the cord right after birth might causes the baby to miss the benefits of receiving blood from the umbilical cord / placenta.
Delayed Cord Clamping (DCC) is when the baby stays attached to the cord for a longer time. Studies show that DCC has many benefits especially for a newborn baby, such as higher iron storage, less need for blood transfusions, and improved circulation. This can be done while the baby is breathing on its own or while we help you baby breath (this is called resuscitation).
This study aims to examine whether DCC while providing resuscitation in infants with CHD is helpful compared to immediate cord clamping.
Prior to the birth of your baby, a sealed envelope will be opened and your baby will be randomly assigned to either the DCC with resuscitation group or the ICC group. 40 babies will be enrolled into this study, 20 in each group. In the DCC group, the umbilical cord will be clamped after 120 seconds during which time your baby will receive the care he/she requires by the NICU team. In the ICC group, the umbilical cord will be clamped immediately and he/she will be brought over the resuscitation bed to be cared for by the same team.
详细描述
Purpose: Do respiratory and cardiovascular function parameters differ in infants with congenital left heart heart disease (CHD) who receive active resuscitative care during Delayed Cord Clamping (DCC) compared to immediate cord clamping (ICC)?
Hypothesis: Infants with left heart CHD who receive active resuscitative care during DCC will have improved heart rate in the delivery room (DR) compared to those who receive ICC.
Justification: Based on our literature review, this is the first study to assess the effect of initiating resuscitation during DCC on cardiovascular function in newborn infants with left heart CHD. We speculate that initiating resuscitation during DCC will lead to a smoother transition with improving respiratory and cardiovascular stability in these infants. The results of our study will than be used to organise a large-multi-center trial.
Objectives: infants with left heart CHD who receive active resuscitative care during DCC will have improved heart rate in the delivery room (DR) compared to those who receive ICC.
Research Method/Procedures:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 20 Minutes(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with rights or left heart congenital malformation
排除标准
- •Infants with no heart congenital malformation
结局指标
主要结局
Increase in heart rate
时间窗: At 5 minutes after birth
次要结局
未报告次要终点
