Delayed Cord Clamping in VLBW Infants Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 8
- 主要终点
- Infants enrolled
研究概览
简要总结
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.
详细描述
This study tested the hypothesis that delaying clamping of the umbilical cord in extremely low birthweight (ELBW) infants would result in additional blood transfusion from the placenta to the baby, increasing the infant's blood volume and blood pressure. Higher blood pressure may improve blood flow to the brain that may reduce potential the risk of hypoxic ischemic encephalopathy (HIE) and/or intraventricular hemorrhage (IVH). The additional placental flow may also increase the amount of stem cells and cytokines flowing to the baby, improving immune status and reducing the risk of infection, while at the same time reducing the need for blood transfusions in the neonatal period.
This was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.
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
- None
入排标准
- 年龄范围
- 0 Minutes 至 1 Minute（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born at participating centers at 24-27 weeks gestation
- •Singletons
- •Obstetrician approval for enrollment
- •Parental consent
排除标准
- •Prenatally diagnosed major congenital anomalies
- •Intent to withhold or withdraw care
- •Significant bleeding due to placenta previa or abruption
研究组 & 干预措施
Standard Cord Clamping
干预措施: Standard Cord Clamping (Procedure)
Delayed Cord Clamping
干预措施: Delayed Cord Clamping (Procedure)
结局指标
主要结局
Infants enrolled
时间窗: 6 months
Number of infants enrolled in the pilot within 6 months.
次要结局
- Use of volume expansion or pressor therapy(24 hours of age)
- Blood transfusions(Until hospital discharge or 120 days of life)
- Intention to treat(6 months)
- Hematocrit level(4 hours of age)
- Arterial blood pressure(12 hours of age)