Premature Infants Receiving Milking or Delayed Cord Clamping: Randomized Controlled Multicenter Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,201
- 试验地点
- 35
- 主要终点
- Incidence of severe IVH or death
研究概览
简要总结
This study is being done to find out whether umbilical cord milking (UCM) is at least as good as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent death in premature newborns. The investigators will study short and long term outcomes of infants delivered before 32 weeks gestation that receive either UCM or DCC.
* The trial was stopped by the DSMB for safety in the small strata. They subsequently allowed for continuation of the trial in infants 29-32+6 wk GA.
详细描述
Aim 1. Compare the incidence of severe intraventricular hemorrhage (IVH) and/or death in premature newborns <33 weeks gestational age (GA) delivered by C/S receiving UCM to those receiving DCC.
Hypothesis1: First demonstrate infants in the UCM group are not inferior to the DCC group (reject H10).
Hypothesis2: If H1 is true, demonstrate lower incidence of severe IVH and/or death in UCM infants compared to DCC.
Aim 2. Compare the safety and efficacy profiles of premature newborns <33 weeks GA delivered by C/S receiving UCM vs. DCC during their hospitalization.
Hypothesis3: UCM group will have a decreased need for resuscitation interventions with no differences in bilirubin or polycythemia compared to DCC.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
It is not possible to blind the delivering obstetrician, however all other caregivers will be blinded. The procedure will be documented as "placental transfusion" in the delivery summary or admission-progress notes and all study assessments whether primary (head US) or secondary (neurodevelopmental exams) will be performed by blinded team members.
入排标准
- 年龄范围
- 23 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •23 to 32 +6 Gestational age (currently enrolling 29 to 32+6 weeks)
- •Multiples without Twin-to-twin Transfusion Syndrome (TTTS)
排除标准
- •Congenital anomalies
- •Major cardiac defects
- •Placental abruption or previa with hemorrhage
- •Cord prolapse
- •Bleeding Accreta
- •Monochorionic multiples with evidence of TTTS
- •Fetal or maternal risk (i.e. compromise)
- •Parents declined study
- •Unlikely to return for 2 yr Follow Up
结局指标
主要结局
Incidence of severe IVH or death
时间窗: Through study completion at death or discharge, up to 6 months corrected gestational age (CGA)
Severe intraventricular hemorrhage of grade 3 or 4 or death
次要结局
- All Grade IVH(Through study completion at discharge, up to 6 months corrected gestational age (CGA))
- Severe IVH (Grade 3 or 4)(Through study completion at discharge, up to 6 months corrected gestational age (CGA))
- Delivery room interventions(In the first 10 minutes of life)
- Hemoglobin/Hematocrit at 4 hours(4 +/- 2 hours of life)
- Blood pressures in the first 24 hours of life(In the first 24 hours of life)
- Incidence of Severe IVH or death in infants <28 weeks gestation(Through study completion at discharge, up to 6 months corrected gestational age (CGA))
研究者
Anup Katheria, M.D.
Director of Neonatal Research Institute
Sharp HealthCare