Delayed Cord Clamping at 30 vs. 60 Seconds for Very Low Birth Weight Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Intraventricular hemorrhage
研究概览
简要总结
The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.
详细描述
Immediately following delivery, up to 40% of the total blood volume available to the infant is in the placenta. Over a period of 30 seconds to 3 minutes, a significant portion of this blood is transferred to the infant through the umbilical cord. Delayed cord clamping following delivery facilitates this transfer of blood.
Preterm infants are very susceptible to the effects of anemia and hypovolemia. A recent meta-analysis showed that a brief delay in umbilical cord clamping (30-60 seconds) decreases the risk of anemia, blood transfusion, intraventricular hemorrhage, necrotizing enterocolitis, and the need for blood pressure support after delivery. The same meta-analysis showed no impact on Apgar scores or hypothermia due to a brief delay in resuscitation efforts to allow delayed cord clamping.
Preterm infants are at significant risk for IVH and as high as 20% of very low birth weight infants will have it. IVH is an important cause of brain injury in these infants. In our study, we would like to determine the optimal timing of delayed cord clamping in order to prevent IVH in these infants.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women who are expected to deliver a very low birth weight infant
- •Neonates born weighing >= 500g and <1500 grams
- •Mother 18 years of age or older
- •English speaking mother
排除标准
- •Placental abruption
- •Vasa previa
- •Fetal hydrops or other signs of fetal volume overload
- •Other major fetal anomalies
- •Placenta Accreta
- •Mother < 18 years of age
- •Non-English speaking mother
- •Infants >= 1500g (3.3 lbs) or <500g
研究组 & 干预措施
30 seconds
For subjects in the 30 second arm, the umbilical cord will be clamped at 30 seconds after delivery.
干预措施: Delayed cord clamping at 30 seconds (Procedure)
60 seconds
For subjects in the 60 second arm, the umbilical cord will be clamped at 60 seconds after delivery.
干预措施: Delayed cord clamping at 60 seconds (Procedure)
结局指标
主要结局
Intraventricular hemorrhage
时间窗: During NICU admission up to 6 months
Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage.
次要结局
- Bilirubin levels(During NICU admission up to 6 months)
- Hemoglobin and hematocrit(During NICU admission up to 6 months)
- Need for blood transfusion(During NICU admission up to 6 months)
- Delivery room temperature(Delivery)