Sustained Aeration of Infant Lungs Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 33
- 主要终点
- Combined Outcome of Death or Bronchopulmonary Dysplasia
研究概览
简要总结
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age.
Hypotheses:
- Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will reduce the need for mechanical ventilation in the first seven days of life, and reduce need for surfactant use; and
- A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36 weeks post-menstrual age (PMA) than standard PEEP/CPAP
详细描述
The SAIL trial aims to provide evidence for changing policy or standard of care. The context of this trial is an unacceptable rate of poor long-term outcomes of preterm infants born as Extremely Low Gestational Age Newborns (ELGAN) <1000 g birthweight (BW), but especially for those born between 23-26 weeks' gestational age (GA). Such infants are the most vulnerable and immature in all organ systems, including the lungs and the brain. These infants are at high risk of death and bronchopulmonary dysplasia (BPD) during their initial hospitalization, neurodevelopmental impairment (NDI) and pulmonary problems in infancy and childhood.
The SAIL trial focuses on facilitating the difficult transition of these most vulnerable infants from a liquid filled in-utero lung to an ex-utero air-filled lung. Sustained Inflation (SI) is a promising delivery room (DR) intervention, with evidence of short-term efficacy with minimal risk of additional harm beyond current standard accepted Newborn Resuscitation Program (NRP) Guidelines. This protocol proposes a fully informed consenting procedure. We propose to evaluate the impact of a SI in the DR on the need for mechanical ventilation in the first week of life which would also impact mortality rates and the incidence and severity of BPD.
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
- 23 Weeks 至 26 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age (GA) at least 23 weeks but less than 27 completed weeks by best obstetrical estimate
- •Requiring resuscitation/respiratory intervention at birth -"apneic, labored breathing, gasping" (as defined in NRP 2011 AAP 6th Edition p.45)
排除标准
- •Considered non-viable by the attending neonatologist
- •Refusal of antenatal informed consent
- •Known major anomalies, pulmonary hypoplasia
- •Mothers who are unable to consent for their medical care and who do not have a surrogate guardian will not be approached for consent
结局指标
主要结局
Combined Outcome of Death or Bronchopulmonary Dysplasia
时间窗: 36 weeks
To determine in infants born at 23-26 weeks gestational age requiring respiratory support at birth, which of two treatment strategies when compared, results in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia.
次要结局
- Pneumothorax or New Chest Drains in the First 48 Hours of Life(First 48 hours of life)
- Death in Hospital(During expected hospitalization 23 - 40 weeks PMA)
- Heart Rate in the Delivery Room (DR)(First 30 seconds of life in DR)
- Need for Intubation in Delivery Room(First 30 seconds to 24 hours of life)
- Intraventricular Hemorrhage by All Grades(48 hours to 10 days)
- Chest X-ray Between Days 7-10(First 7-10 days of life)
- Pneumothorax and Pulmonary Interstitial Emphysema (PIE)(First 10 days of life)
- Retinopathy of Prematurity (ROP) Stage 3 or Greater Requiring Treatment(36 weeks)
- Oxygen Profile Over First 24 Hours(First 24 hours post delivery)
- Survival to Discharge Home Without BPD, Retinopathy of Prematurity (Grades 3 & 4), or Significant Brain Abnormalities on Head Ultrasound(Expected discharge between 36 - 40 weeks PMA)
- Neurodevelopmental and Respiratory Outcome at 22-26 Months Corrected Gestational Age(22-26 months corrected gestational age)
- Oxygen Profile With Highest FiO2 Level up to 48 Hours(48 hours of life)
- Detailed Status on Departure From the Delivery Room (DR)(Resuscitation time will vary - 1 to 30 minutes)
- Use of Inotropes on Arrival in NICU(First 48 hours of life)
- Pressure-volume Characteristics in the Delivery Room (DR)(Expected average 30 minutes)
- Duration of Any Chest Drain In-situ Post-DR(During hospitalization - up to 36 weeks Post Menstrual Age (PMA))
- Death or Need for Positive Pressure Ventilation(First 7 days of life)
- Highest FiO2 and Area Under the FiO2 Curve for the First Week of Life(First 7 days of life)
- Duration of Respiratory Support (Ventilation, CPAP, Supplemental Oxygen)(During hospitalization - up to 36 weeks Post Menstrual Age (PMA))
- Use of Postnatal Steroids for Treatment of BPD(During hospitalization - up to 36 weeks Post Menstrual Age (PMA))
- Length of Hospital Stay(Average discharge between 36 - 40 weeks PMA)