NCT01393834终止不适用
Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - a Randomized, Controlled Trial
Medstar Health Research Institute0 个研究点目标入组 2 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 主要终点
- Adverse Neonatal Event
研究概览
简要总结
This study is being done to evaluate if delaying cord clamping or milking the umbilical cord of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies among doctors, but there is information that shows that delaying clamping of the umbilical cord in premature infants may reduce the rate of the baby needing a blood transfusion, decrease the risk of infection and bleeding in the head.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 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 24 0/7 - 28 6/7 weeks gestation
- •Women ages 18 and older
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 previa or other known abnormal placentation (e.g. placenta accreta)
结局指标
主要结局
Adverse Neonatal Event
时间窗: up to 24 weeks after birth
composite of bronchopulmonary dysplasia (BPD), necrotising eneterocolitis (NEC), grade 3 or 4 intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), or death prior to discharge home
次要结局
- Maternal estimated blood loss(up to 1 hour after delivery)
- Any grade intraventricular hemorrhage(up to 24 weeks after birth)
- Severe intraventricular hemorrhage (grade 3 or 4)(up to 24 weeks after birth)
- Periventricular leukomalacia(up to 24 weeks after birth)
- Bronchopulmonary dysplasia(up to 24 weeks after birth)
- Peak transcutaneous and/or serum bilirubin concentrations(up to 24 weeks after birth)
- Phototherapy(up to 24 weeks after birth)
- Ionotropic support(up to 24 weeks after birth)
- Neonatal intesive care unit (NICU) length of stay(up to 24 weeks after birth)
- Sepsis(up to 24 weeks after birth)
- Necrotizing enterocolitis(up to 24 weeks after birth)
- Respiratory distress syndrome(up to 24 weeks after birth)
- Number of blood transfusions while in the neonatal intensive care unit(up to 24 weeks after birth)
- Ventilator time(up to 24 weeks after birth)
- Apgar score <7 at 5 minutes(at 5 minutes after birth)
- Umbilical cord pH < 7.0(up to 30 minutes after birth)
- Blood pressure on admission to neonatal intensive care unit(at 30 minutes after birth)
- Polycythemia(up to 24 hours of life)
- Hematocrit on admission to neonatal intensive care unit(up to 4 hours after birth)
- Neonatal death(up to 24 weeks of life)
- Length of 3rd stage of labor(up to 1 hour after birth)
- Use of uterotonic agents(up to 1 hour after birth)
- Maternal blood transfusion(up to 5 days after delivery)
- Manual removal of placenta(up to 1 hour after birth)
- Operating time for cesarean delivery(up to 3 hours after birth)
研究者
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