A Randomized Controlled Trial of Umbilical Cord Milking Versus Immediate Cord Clamping on Systemic Blood Flow in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Superior Vena Cava Flow
研究概览
简要总结
Premature babies are at risk for bleeding in their brains, which can result in developmental delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical cord immediately after birth is standard, but delaying this procedure allows more of the baby's blood to move from the placenta into the baby and prevents head bleeds. However, a delay in clamping the umbilical cord is not usually done in very premature babies, because it would delay their treatment and they could get cold. Milking the umbilical cord is another way to give premature babies more of their own blood while avoiding a delay in treatment. Umbilical cord milking has been shown to improve blood pressure, decrease the need for blood transfusions, and increase the amount of urine made in the first few days of life.
详细描述
The aim of this study is to determine whether umbilical cord milking improves blood flow in premature babies, and thereby reduce the occurrence of neurological problems. The investigators predict that the blood flow measured by ultrasounds of the heart will be higher in babies who receive umbilical cord milking compared to those whose cords are clamped immediately. Secondly, the investigators predict that cord milking will improve blood volume, blood pressure, and urine output, and delay the need for blood transfusions.
This will be the first study to look at the effect that umbilical cord milking has on important measures of blood flow, which can predict bleeding in the head and subsequent developmental problems in very premature babies.
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 (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants < 32 weeks gestation
排除标准
- •obstetrician's refusal to participate
- •multiple gestations (if Di-Mo placentation) surrogate delivery
- •parental desire for cord blood banking
- •major congenital anomalies
- •severe maternal illness
- •placental abruption or previa
- •ruptured uterus at delivery, or hemoperitoneum
研究组 & 干预措施
Umbilical Cord Milking
Umbilical Cord Milking involved milking the umbilical cord at birth.
干预措施: Umbilical Cord Milking (Procedure)
Immediate Cord Clamping
Umbilical cord is clamped soon after birth without any milking of the cord.
干预措施: Immediate Cord Clamping (Procedure)
结局指标
主要结局
Superior Vena Cava Flow
时间窗: 6 hours
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 6 hours.
次要结局
- Neurodevelopmental Outcomes(between 18 and 36 months of life)
- number of blood transfusions(36 weeks corrected gestational age)
- Blood Pressure(30 hours of life)
- Superior Vena Cava Flow(30 hours of life)
研究者
Anup Katheria, M.D.
Director of Neonatal Research
Sharp HealthCare