Management of the Patent Ductus Arteriosus in Premature Infants Trial (PDA Trial)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 482
- 试验地点
- 38
- 主要终点
- Death or Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA
研究概览
简要总结
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
详细描述
This is a pragmatic randomized multicenter, effectiveness study comparing active treatment of a symptomatic patent ductus arteriosus (sPDA) to expectant management. We hypothesize in premature infants with a sPDA, expectant management reduces the incidence proportion of death or BPD by 10% (from 50% to 40%) when compared to active treatment.
Participants with a sPDA allocated to the active treatment arm will receive intravenous administration of indomethacin or ibuprofen (depending on center preference). The decision to ligate will be left to the clinical team. Participants with a sPDA allocated to the expectant management arm will receive supportive care at the clinical team's discretion and will receive indomethacin/ibuprofen or ligation if the infant develops cardiopulmonary compromise. The decision to ligate will be left to the clinical team.
The primary endpoint for the study will be death or BPD (as assessed by the physiologic definition) at 36 weeks postmenstrual age (PMA).
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
- 48 Hours 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postnatal age 48 hours -21 days
- •Infant 22 0/7 to 28 6/7 weeks gestation at birth
- •sPDA, as defined as:
- •Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA on echocardiogram
- •Mild or Moderate Clinical Criteria with Large PDA on echocardiogram
排除标准
- •Cardiopulmonary compromise
- •Known congenital heart disease (besides atrial septal defect or ventricular septal defect)
- •Known pulmonary malformation (e.g. congenital lobar emphysema, congenital pulmonary adenomatous malformation)
- •Any condition which, in the opinion of the investigator, would preclude enrollment
研究组 & 干预措施
Active Treatment Group
Infants assigned to the active treatment group will receive indomethacin or ibuprofen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin or ibuprofen will be left to the center, however, infants may only receive one or the other.
干预措施: Active Treatment (Other)
Expectant Management Group
Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.
干预措施: Expectant Management (Other)
结局指标
主要结局
Death or Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA
时间窗: birth to 36 week postmenstrual age
Death or BPD. BPD will be defined by the physiologic definition.
次要结局
- Mortality at 36 weeks PMA(birth to 36 week postmenstrual age)
- Necrotizing Enterocolitis (NEC) at 36 weeks PMA(birth to 36 weeks post menstrual age)
- Weight at 36 weeks PMA(birth to 36 weeks post menstrual age)
- Receipt of therapies designed to close the PDA(birth to 120 days)
- Mortality before discharge(birth to 120 days of life)
- Bronchopulmonary dysplasia - NIH Consensus Definition(birth to 36 week postmenstrual age)
- Height at 36 weeks PMA(birth to 36 weeks post menstrual age)
- Bronchopulmonary dysplasia - Physiological Test(birth to 36 week postmenstrual age)
- Retinopathy of Prematurity at 36 weeks PMA(birth to 36 weeks post menstrual age)
- Head Circumference at 36 weeks PMA(birth to 36 weeks post menstrual age)