Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,207
- 试验地点
- 20
- 主要终点
- Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition.
研究概览
简要总结
A sub-study to evaluate longer-term developmental outcomes in non-vigorous term and near-term newborns who receive umbilical cord milking in comparison to those who undergo early cord clamping at delivery.
详细描述
This sub-study investigates the potential difference in neurodevelopmental outcomes during early childhood between newborns who undergo umbilical cord milking and those who experience early cord clamping at birth. The developmental progress of participants is evaluated using the Ages and Stages Questionnaire-3 which measures five developmental areas: communication, problem-solving, fine motor skills, gross motor skills, and personal-social behavior. Additionally, the Modified Checklist for Autism in Toddlers is employed as a secondary assessment. The recruitment of participants is conducted through the primary study Umbilical Cord Milking in Nonvigorous Infants trial (NCT03631940) with the method of umbilical cord management for each newborn being dictated by the randomized treatment allocation of the primary study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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 the primary trial NCT:03631940 and parental written consent to participate in developmental follow-up through 2 years of age was obtained.
- •Enrolled in the primary trial NCT:03631940 and did not survive to 2 years.
排除标准
- •Enrolled in the primary trial NCT:03631940 but parent/guardian declined consent to developmental follow-up participation.
结局指标
主要结局
Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition.
时间窗: 22 to 26 months
Neurodevelopmental Outcome at 2 Years of Age defined as overall and domain scores on the Ages and Stages, third edition. Questionnaire. Minimum score of 0 and maximum score of 60 per domain. Scores from 5 subscales are summed to obtain a total score. 5 domains assessed include communication, gross motor, fine motor, problem solving, personal social with a total minimum score of 0 and maximum score of 300. Higher scores indicate a lower risk of developmental delays or conditions
次要结局
- Score Ranges on the Modified Checklist for Autism in Toddlers Questionnaire(22-26 months)
研究者
Anup Katheria, M.D.
Director, Neonatal Research Institute
Sharp HealthCare