VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 570
- 试验地点
- 12
- 主要终点
- Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age
研究概览
简要总结
The purpose of this study is to determine whether providing ventilatory assistance prior to umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in extremely preterm (EPT) infants, compared to standard care of providing ventilatory assistance after cord clamping.
详细描述
Newborns with gestational age 23 wks 0 days through 28 wks 6 days are randomized to control (delayed cord clamping for at least 30 seconds, or up to 60 seconds if breathing spontaneously, with ventilatory assistance provided after) or the VentFirst intervention (ventilatory assistance with continuous positive airway pressure or positive pressure ventilation given starting 30 seconds after birth and cord clamping at 120 seconds).
The primary outcome is lack of IVH on 7-10 day head ultrasound or death before day 7.
The study was designed to test the impact of the intervention in each of two cohorts:
- Infants not breathing well 30 seconds after birth
- Infants breathing well 30 seconds after birth
Randomization and analysis is stratified by gestational age category:
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
- Single (Outcomes Assessor)
盲法说明
Board-certified radiologists interpreting head ultrasound findings are blinded to study arm. Consensus on maximum grade of IVH between two radiologists (some combination of site radiologist and one of three external readers blinded to each others' interpretation) is required.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •23 0/7 - 28 6/7 weeks' gestation at delivery
排除标准
- •Life-threatening condition of fetus (e.g. severe hydrops, lethal chromosomal abnormality, severe congenital malformation)
- •Suspected severe fetal anemia
- •Monochorionic or monoamniotic twins
- •Multiple gestation greater than twins
- •Decision made for comfort care only
- •Medical emergency necessitating emergency delivery (e.g. complete placental abruption)
- •Obstetrician or Neonatology concern for inappropriateness of the study intervention based on maternal or fetal factors.
研究组 & 干预措施
VentFirst 120 Seconds Cord Clamping
Assisted ventilation (face mask continuous positive airway pressure, CPAP, or positive pressure ventilation, PPV) is provided prior to cord clamping at 120 seconds.
干预措施: VentFirst 120 Seconds Cord Clamping (Procedure)
Standard 30-60 Seconds Cord Clamping
Standard treatment for extremely preterm infants which is delayed cord clamping 30-60 seconds after birth, and assisted ventilation after cord clamping.
干预措施: Standard 30-60 Seconds Cord Clamping (Procedure)
结局指标
主要结局
Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age
时间窗: 7-10 days after birth
presence of any grade IVH on HUS
次要结局
- 5 minute Apgar Score <5(5 minutes after birth)
- Severe brain injury on head ultrasound(Birth through 36 weeks' postmenstrual age)
- Death(Birth through 36 weeks' postmenstrual age)
- Lowest hematocrit in first 24 hours(First 24 hours after birth)
- Medication for low blood pressure in first 24 hours(First 24 hours after birth)
- Number of red blood cell transfusions birth through day 10(First 10 days after birth)
研究者
Karen Fairchild, MD
Professor of Pediatrics
University of Virginia