A Cluster Randomized Clinical Trial of Umbilical Cord Milking Versus Early Cord Clamping on Short and Long-term Outcomes in Neonates Who Are Non-Vigorous at Birth
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,442
- 试验地点
- 16
- 主要终点
- Neurodevelopmental Outcome at 2 Years of Age
研究概览
简要总结
An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking (UCM) or early cord clamping (ECC).
详细描述
The CORDMILK Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were non-vigorous at birth and enrolled in the CORDMILK trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ECC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
入排标准
- 年龄范围
- 22 Months 至 26 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in CORDMILK trial
- •Non-vigorous at birth
排除标准
- 未提供
研究组 & 干预措施
Umbilical Cord Milking
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 10-15 seconds.
干预措施: Umbilical Cord Milking (Other)
Early Cord Clamping
The umbilical cord is clamped immediately after the delivery (within 60 seconds).
结局指标
主要结局
Neurodevelopmental Outcome at 2 Years of Age
时间窗: 22-26 months
Neurodevelopmental assessment will be performed by the trained and experienced examiner who will be blinded to the interventions. Severe neurodevelopmental impairment will be defined having at least one of the following: BSID (IV) composite cognitive score \<70, GMFCS level 3-5, blindness (vision \<20/200), or hearing impairment requiring hearing aids/cochlear implant. Moderate neurodevelopmental impairment will be defined as having a cognitive composite score 70-84, GMFCS level 2, unilateral blindness (vision/20/200 in only one eye), or hearing impairment with no amplification/cochlear implant.
次要结局
- Neurodevelopmental Outcome at 1 Year of Age(10-14 months)
研究者
Zubair Aghai
Professor of Pediatrics
Nemours Children's Clinic