Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 420
- 试验地点
- 17
- 主要终点
- Death or Bronchopulmonary Dysplasia
研究概览
简要总结
This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.
详细描述
This multicenter, randomized, double-masked, controlled clinical trial evaluated the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with respiratory failure secondary to respiratory distress syndrome (RDS), sepsis/pneumonia, aspiration syndrome, idiopathic pulmonary hypertension and/or suspected pulmonary hypoplasia.
Infants were followed until death or discharge to home. The trial compared iNO therapy to mock gas delivery as the control, and otherwise incorporated conventional management strategies (including treatment with surfactant and high frequency ventilation as adjuncts to iNO therapy).
During the initial dosing, iNO was started at 5 ppm and could be increased to 10 ppm. If the infant did not respond, study gas was discontinued. For infants who responded to study gas, a gradual weaning was initiated. The total exposure to study gas did not exceed 336 hours (14 days). Infants were monitored for signs of toxicity.
Medical and neurodevelopmental outcome of surviving infants were assessed at 18 to 22 months corrected age by masked, certified examiners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 120 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Inhaled Nitric Oxide
Inhaled Nitric Oxide
干预措施: Inhaled nitric oxide (Drug)
Placebo
Inhaled Oxygen
干预措施: Placebo (Drug)
结局指标
主要结局
Death or Bronchopulmonary Dysplasia
时间窗: At 36 weeks post-conceptional age
次要结局
- Neurodevelopmental outcome(18-22 months corrected age)
- Intraventricular Hemorrhage Grade III and IV(At 36 weeks post-conceptional age)
- Days on assisted ventilation(At 36 weeks post-conceptional age)
- Retinopathy of prematurity(At hospital discharge)
- Days on oxygen(At 36 weeks post-conceptual age)
- Supplemental oxygen(At 36 weeks post-conceptual age)
- Air leaks(At 36 weeks post-conceptual age)
- Length of hospitalization(At hospital discharge)