A Randomized Controlled Trial of Short-Delay Cord Clamping as Compared to Extended- Delayed Cord Clamping in Term Neonates That Require Resuscitation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cerebral tissue oxygenation
研究概览
简要总结
To determine whether performing extended delayed cord clamping in term neonates that require resuscitation improves early transition as compared to short-delayed cord clamping.
详细描述
All subjects will receive delayed cord clamping. One group (short-delay) will receive up to one minute of delayed cord clamping and then will be placed either on the mother's abdomen or the life-start trolley if extensive resuscitation is required.
The second group will receive delayed cord clamping for at least 5 minutes and continue until the baby has established breathing without additional support or is stable on respiratory support (no longer received mask PPV for at least 1-2 minutes, i.e. stable on CPAP or intubated). The subject will initially be placed on the mother's abdomen or if the subject needs extensive resuscitation they will be moved to the LifeStart bed to receive resuscitation measures.
In either group if the baby is deemed to be unstable (by medical team) to be on the life-start trolley the cord will be clamped and the baby will be moved to an adjacent warmer for resuscitation.
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
- 37 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria: Gestation 37 weeks or greater that require attendance at delivery of neonatal provider due to an at risk delivery.
排除标准
- •Planned cesarean birth, placental abruption, multiple gestations, or known congenital anomalies.
研究组 & 干预措施
Short Delay Cord Clamping
Subject will have umbilical cord clamped and cut by 1 minute of life.
干预措施: Short Delay Cord Clamping (Procedure)
Extended Delay Cord Clamping
Subject will have umbilical cord clamped and cut after at least 5 minutes of delayed cord clamping. Duration of cord clamping after 5 minutes will depend on if the subject is breathing and/or if the cord has stopped pulsating
干预措施: Extended Delay Cord Clamping (Procedure)
结局指标
主要结局
Cerebral tissue oxygenation
时间窗: 12 hours of life
The need for oxygen, positive pressure ventilation, intubation
次要结局
- Heart rate(First 5 minutes of life)
- Oxygen saturation(over the first 5 minutes of life)
- Arterial and Venous Umbilical Cord Blood Gases(At birth)
- Blood pressure(12 hours of life)
- delivery room resuscitation(at birth)
- Need for NICU admission(at birth)
- Hospitalization days(up to 24 weeks)
- Need for hypothermia for hypoxic ischemic encepalopathy(at birth)
- Hemoglobin(12 hours of life)
- Apgar Score(First 10 minutes of life)
- Neurodevelopmental impairment(12 month followup)
- Bilirubin level(12-48 hours)
- Post delivery survey(at birth)
- Hemoglobin(First 5 minutes of life)
研究者
Anup Katheria, M.D.
Director Neonatal Reseach Institute
Sharp HealthCare