The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 6
- 主要终点
- Superior Vena Cava Flow
研究概览
简要总结
Premature babies can be very sick and have bleeding in the brain. Giving babies more blood before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been shown to reduce the risk of bleeding in the brain. This may be related to improving perfusion to the brain. However, some studies suggest that delayed cord clamping may not increase hemoglobin or blood volume in babies delivered by cesarean section. Milking the umbilical cord may give more blood in babies delivered by Cesarean Section may improve perfusion and reduce bleeding in the brain.
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 (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 23 0/7 - 31 6/7 weeks gestation
排除标准
- •Planned vaginal breech delivery
- •Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)
- •Fetal death in utero
- •Red cell isoimmunization
- •Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization
- •Placenta accreta or abruption
研究组 & 干预措施
Umbilical Cord Milking
Milking the umbilical cord 4 times towards the infants at a speed of 20cm/2 seconds
干预措施: Umbilical Cord Milking (Procedure)
Delayed Cord Clamping
Delayed clamping of the umbilical cord for 45-60 seconds
干预措施: Delayed Cord Clamping (Procedure)
结局指标
主要结局
Superior Vena Cava Flow
时间窗: <12 hours of life
次要结局
- Use of uterotonic agents(up to 1 hour after birth)
- Maternal hemoglobin(within 48 hours after delivery)
- Severe intraventricular hemorrhage (grade 3 or 4)(up to 24 weeks after birth)
- Phototherapy(up to 24 weeks after birth)
- Delivery Room Interventions(10 minutes of life)
- Hemoglobin(4 weeks of life)
- Neurodevelopmental impairment 18-36 months(18-36 months)
- Necrotizing enterocolitis(up to 24 weeks after birth)
- Apgar score <7 at 5 minutes(at 5 minutes after birth)
- Number of blood transfusions while in the neonatal intensive care unit(up to 24 weeks after birth)
- Ionotropic support(up to 24 weeks after birth)
- Neonatal intensive care unit (NICU) length of stay(up to 24 weeks after birth)
- Polycythemia(up to 24 hours of life)
- Peak transcutaneous and/or serum bilirubin concentrations(up to 24 weeks after birt)
- Ventilator time(up to 24 weeks after birth)
- Blood pressure in first 2 hours of admission to neonatal intensive care unit(2 hours after birth)
- Neonatal death(up to 24 weeks of life)
- Umbilical cord pH < 7.0(up to 30 minutes after birth)
- Intraventricular Hemorrhage detected on Head Ultrasound(up to 24 weeks after birth)
研究者
Anup Katheria, M.D.
Director of Neonatal Research
Sharp HealthCare