Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 648
- 试验地点
- 1
- 主要终点
- Death or Chronic Lung Disease
研究概览
简要总结
The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.
详细描述
The "Delivery room management of premature infants at high risk of respiratory distress syndrome" protocol compares three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk of respiratory distress syndrome. The three approaches to post-delivery care include:
- Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
- Early stabilization on nasal continuous positive airway pressure (NCPAP) with selective intubation and surfactant administration for clinical indications.
- Intubation, prophylactic surfactant administration shortly after delivery and rapid extubation to nasal CPAP.
The primary null hypothesis for this study is that no difference will be found in chronic lung disease and/or mortality at 36 weeks adjusted age in premature infants at high risk of RDS, depending on the method of post-delivery stabilization.
The study is a randomized, multicenter trial conducted at participating Vermont Oxford Network Centers. Participating centers will demonstrate competency in the use of nasal CPAP by successfully completing a web-based, educational program and utilizing nasal CPAP in a minimum of 20 infants in their NICU.
Infants likely to be delivered to women presenting to a participating Vermont Oxford Network Center at high risk of premature delivery at gestational age 26 + 0 to 29 + 6 weeks will be eligible for inclusion. Specific inclusion criteria that must be met prior to randomization include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 26 Weeks 至 29 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants likely to be delivered to women presenting to a participating Vermont Oxford Network Center at high risk of premature delivery at gestational age 26 + 0 to 29 + 6 weeks will be eligible for inclusion. Specific inclusion criteria that must be met prior to randomization include:
- •Imminent delivery
- •No potentially life-threatening congenital anomaly or genetic syndrome
- •No known lung maturity
- •Antenatal steroid status known
- •Written, informed consent obtained (on admission or prior to delivery).
排除标准
- •Stillborn (Apgar score of 0 at one minute of age)
- •Noted to have a potentially life-threatening congenital anomaly or genetic syndrome noted immediately after delivery.
研究组 & 干预措施
PS Group
Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
干预措施: PS Group (Drug)
NCPAP Group
Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
干预措施: NCPAP Group (Device)
ISX Group
Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
干预措施: ISX Group (Drug)
结局指标
主要结局
Death or Chronic Lung Disease
时间窗: at 36 weeks postmenstrual age
Death
时间窗: 36 weeks adjusted age
次要结局
未报告次要终点