Initial Oxygen For Delivery Room Resuscitation Of Preterm Neonates: A Triple-arm, Multi-site, Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 700
- 试验地点
- 6
- 主要终点
- A composite of all-cause mortality or bronchopulmonary dysplasia with the end point of assessment being death or 44 weeks post-menstrual age, whichever is earlier.
研究概览
简要总结
Rationale & gaps in knowledge: The appropriate initial oxygen concentration (FiO2) for delivery room (DR) resuscitation in preterm neonates is unclear. ILCOR recommends 21-30% based on weak evidence. A recent Individual Participant Data meta-analysis reported reduced mortality in greater than 90% oxygen arm compared to 21-30% and 50-65% arms.
Novelty:
• Triple-armed, blinded, multisite, randomized trial.
• Patient-centric composite hard outcomes.
Objectives:
• To compare 90% or 60% FiO2 with 30% FiO2 for initial delivery room resuscitation of very preterm neonates in reduction of death or broncho-pulmonary dysplasia.
• To compare 90% or 60% FiO2 with 30% FiO2 for initial resuscitation of very preterm neonates in reduction of a composite adverse outcome.
• To compare the MRI brain changes in a subset of very preterm neonates resuscitated with an initial FiO2 of 90%, 60% or 30%.
Methods: Consecutive inborn very preterm neonates requiring DR resuscitation will be randomly allocated (stratified by gestation and study-site) to 30%, 60% or 90% initial FiO2. The FiO2 shall be masked from the resuscitating team and outcome assessors. Death or BPD by 44 weeks PMA will be the primary outcome. A composite adverse outcome (Death or BPD or ROP or NEC or brain injury at 44-weeks PMA) will be the secondary outcome. MRI brain at 44-weeks PMA will be done in a subset of 25%. Analysis: ITT and per protocol, adjustment ‘a priori’ covariates - weight, antenatal steroids, and antenatal magnesium sulfate.
Expected outcomes:
• Evidence based recommendations for initial FiO2 for delivery room resuscitation of very preterm neonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 0.10 Day(s) 至 0.20 Day(s)（—）
- 性别
- All
入选标准
- •Consecutively born preterm neonates of less than 32 completed weeks of gestation and requiring delivery room (DR) resuscitation with positive pressure ventilation (PPV) as per the most recent neonatal resuscitation program (NRP) guidelines will be included.
排除标准
- •• Pregnant women with insufficient time during the antenatal period to administer and obtain an informed consent • Antenatally suspected or proven major structural anomalies (those responsible for death, morbidities and disability related to congenital anomalies.
- •as per CDC definition) • Parental request or neonatologist decision to forego resuscitation • Refusal of consent.
结局指标
主要结局
A composite of all-cause mortality or bronchopulmonary dysplasia with the end point of assessment being death or 44 weeks post-menstrual age, whichever is earlier.
时间窗: Death or 44 weeks post-menstrual age, whichever is earlier.
次要结局
- A composite of all-cause mortality or bronchopulmonary dysplasia or retinopathy of prematurity requiring treatment or necrotising enterocolitis (definite or advanced stages) or brain injury (major intra-ventricular hemorrhage or periventricular leukomalacia) with the end point of assessment being death or 44 weeks post-menstrual age, whichever is earlier.(Death or 44 weeks post-menstrual age, whichever is earlier.)
- Structural changes in brain as assessed by MRI brain.(44 weeks PMA (term equivalent age).)
研究者
Venkataseshan Sundaram
Post Graduate Institute of Medical Education and Research