Two Year Developmental Follow-up for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 35
- 主要终点
- Developmental Outcome
研究概览
简要总结
An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.
详细描述
The PREMOD2 Follow-up trial will examine the difference in early childhood neurodevelopmental outcomes of subjects enrolled in the PREMOD2 umbilical cord milking (UCM) vs. delayed cord clamping (DCC) trial, using standardized neurologic and developmental assessments at 22-26 months corrected age (CA). The corrected age may be extended out to 42 months CA due to Covid-19 pandemic for undetermined period of time.
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
- Quadruple (Participant, Care Provider, Investigator, 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 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.
排除标准
- •Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.
结局指标
主要结局
Developmental Outcome
时间窗: 22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic.
Bayley Scales of Infant Development (BSID), 3rd or 4th Ed. Composite Score (cognitive 55-145, language 45-155, motor 45-155; higher scores are better)
次要结局
- Gross Motor Function Classification System Scale (GMFCS)(22-26 months corrected gestational age)
- Moderate/Severe Neurodevelopmental Impairment(22-26 months corrected gestational age)
- Mild Neurodevelopmental Impairment(22-26 months corrected gestational age)
- Cerebral Palsy (CP)(22-26 months corrected gestational age)
- Any grade intraventricular hemorrhage (IVH) in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)(From birth through hospital discharge, up to 6 months corrected gestational age (CGA))
- Death in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)(From birth through hospital discharge, up to 6 months corrected gestational age (CGA))
- Compare neurodevelopmental outcomes from BSID assessments in newborns 23-32 weeks GA delivered by C-Section with those born by vaginal delivery receiving UCM or DCC.(22-26 months corrected gestational age)
- Compare neurodevelopmental outcomes from ASQ assessments in newborns 23-32 weeks GA delivered by C-Section with those born by vaginal delivery receiving UCM or DCC.(22-26 months corrected gestational age)
- Developmental Outcomes assessed by Ages & Stages Questionnaire, 3rd ed. (ASQ-3) five domains: Communication, Gross motor, Fine motor, Problem solving and Personal-social in infants born between 23-32+6 weeks GA who received UCM or DCC.(22-26 months corrected gestational age)
- Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool.(22-26 months corrected gestational age)
- Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC(22-26 months corrected gestational age)