Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,316
- 试验地点
- 22
- 主要终点
- Survival Without Bronchopulmonary Dysplasia (BPD)
研究概览
简要总结
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.
详细描述
Study subjects were infants of 24 0/7ths to 27 6/7th weeks at birth for which a decision has been made to provide full resuscitation as required. Infants 27 weeks or less gestation (completed weeks by best obstetric estimate) were enrolled because more than 80% of such infants in the Network are intubated, usually early in their neonatal course. The feasibility trial demonstrated that the five NICHD centers involved could reduce intubation in the delivery room to less than 50% of such infants if they are not intubated for surfactant. We excluded infants of 23 weeks or less in view of their extremely high mortality and morbidity, and their almost universal need for delivery room intubation for resuscitation. Secondary studies included: neuroimaging/MRI, growth, and breathing outcomes.
Strata: There were two randomization strata, infants of 24 0/7ths to 25 6/7ths weeks, and infants of 26 0/7ths-27 6/7ths weeks by best obstetrical estimate.
Randomization:
Randomization was stratified by gestational age group, occurred prior to delivery for consented deliveries, and was performed by utilizing specially prepared double-sealed envelopes. Deliveries were randomized as a unit, thus multiples, twins, triplets, etc. were randomized to the same arm of the trial.
Informed Consent:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 27 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with a minimal gestational age of 24 weeks 0 days to 27 completed weeks (up to 27 6/7ths) by best obstetrical estimate
- •Infants who will receive full resuscitation as necessary, i.e., no parental request or physician decision to forego resuscitation
- •Infants whose parents/legal guardians have provided consent for enrollment, or
- •Infants without known major congenital malformations
排除标准
- •Any infant transported to the center after delivery
- •Infants whose parents/legal guardians refuse consent
- •Infants born during a time when the research apparatus/study personnel are not available
- •Infants < 24 weeks 0 days or > 28 weeks 0 days, completed weeks of gestation
研究组 & 干预措施
Surfactant and Low Oxygen
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
干预措施: Supplemental oxygen with target saturation of 85 to 89% (Drug)
Surfactant and Low Oxygen
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
干预措施: Surfactant (Drug)
Surfactant and High Oxygen
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturationof 91% to 95%
干预措施: Surfactant (Drug)
Surfactant and High Oxygen
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturationof 91% to 95%
干预措施: Supplemental oxygen with target saturation of 91 to 95% (Drug)
CPAP and Low Oxygen
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
干预措施: Continuous Positive Airway Pressure (CPAP) (Device)
CPAP and Low Oxygen
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
干预措施: Supplemental oxygen with target saturation of 85 to 89% (Drug)
CPAP and High Oxygen
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
干预措施: Continuous Positive Airway Pressure (CPAP) (Device)
CPAP and High Oxygen
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
干预措施: Supplemental oxygen with target saturation of 91 to 95% (Drug)
结局指标
主要结局
Survival Without Bronchopulmonary Dysplasia (BPD)
时间窗: 36 weeks
Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)
时间窗: 55 weeks
次要结局
- Death(18-22 months)
- Periventricular Leukomalacia (PVL)(From birth through first 120 days of life.)
- Threshold Retinopathy of Prematurity (ROP) Requiring Surgery(From birth through first 120 days of life.)
- Death or Neurodevelopmental Impairment(18-22 months)
- Duration of Mechanical Ventilation(Entire NICU stay, up to 120 days)
- Survival Without Ventilation(From birth through first 7 days of life.)
- Received Surfactant Treatment(From birth through 120 days of life.)
- Number of Participants With Air Leaks(From birth through first 14 days of life.)
- Physiological Bronchopulmonary Dysplasia(36 weeks post menstrual age.)
- Severe Intraventricular Hemorrhage (IVH)(From birth through first 120 days of life.)
- Endotracheal Intubation(Delivery Room, post-delivery)
- Duration of Oxygen Supplementation(From birth through first 120 days of life.)
- Pulse Oximetry Values > 90%(From birth through first 120 days of life.)
- Blindness in at Least One Eye(18-22 months)
- Received Postnatal Steroids(From birth through first 120 days of life.)
- Necrotizing Enterocolitis (NEC)(From birth through first 120 days of life.)
- Cerebral Palsy(18-22 months)