Long-term Outcomes of Umbilical Cord Milking in Term and Late Preterm Neonates Who Are Depressed at Birth
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Neurodevelopmental Outcome at 2 Years of Age
研究概览
简要总结
An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC).
详细描述
The MIDAB-Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were depressed at birth and enrolled in MIDAB trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ICC 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
- Parallel
- 主要目的
- Supportive Care
- 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
- 3 Months 至 26 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in MIDAB trial
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)
Immediate Cord Clamping
The umbilical cord is clamped immediately after the delivery.
结局指标
主要结局
Neurodevelopmental Outcome at 2 Years of Age
时间窗: 22-26 months
Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire
次要结局
- Fidgety Movements at 3 months of age(3-5 months)
- Neurodevelopmental Outcome at 1 Year of Age(10-14 months)
- Autism Outcome(22-26 months)
研究者
Zubair Aghai
Professor of Pediatrics
Nemours Children's Clinic