A Randomized Controlled Trial of Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- The number of depressed neonates in whom umbilical cord milking was performed.
研究概览
简要总结
The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth.
详细描述
Hypoxic-ischemic encephalopathy (HIE) is a brain injury in neonates due to inadequate blood flow and oxygen delivery to the neonatal brain. Umbilical cord milking can potentially improve brain injury in neonates with HIE. The objective of this study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth. The investigators hypothesized that umbilical cord milking is feasible and safe in neonates who are depressed at birth. The investigators also hypothesized that umbilical cord milking will increase stem cells in neonatal blood circulation and improve short term outcomes in neonates with moderate and severe HIE.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 1 Minute（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term and near term neonates (35 weeks and more)
- •Depressed at birth
排除标准
- •Congenital malformation of central nervous system
- •Chromosomal abnormalities
- •Major congenital malformations
研究组 & 干预措施
Umbilical cord milking
At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord.
干预措施: Umbilical Cord Milking (Procedure)
Immediate cord clamping
At birth, neonate will be held at the level of placenta and umbilical cord will be clamped immediately (standard of care for depressed neonates).
结局指标
主要结局
The number of depressed neonates in whom umbilical cord milking was performed.
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days
The number of neonates who are depressed at birth will be determined and the percentage of depressed neonates in whom UCM performed will be calculated. The investigators expect that more than 80% of neonates who qualify will receive UCM. The investigators will aslo compare resuscitation efforts (use of positive pressure ventilation, intubation, chest compression, medication and fluid boluses) and short term outcomes of resuscitation (5 minutes apgar, severity of HIE, blood gas at 1 hour) in neonates with and without UCM.
次要结局
- The effect of umbilical cord milking on stem and progenitor cells in peripheral blood of neonates.(24 hours)
- The effect of umbilical cord milking on neurotrophic factors in peripheral blood of neonates.(24 hours)
- The effect of umbilical cord milking on monocytes and lymphocytes in peripheral blood of neonates.(24 hours)
- Survival and short term outcomes in neonates with moderate and severe HIE(Participants will be followed for the duration of hospital stay, an expected average of 5 days)