Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Requiring Mechanical Ventilation or Positive Pressure Support on Days 5-14 After Birth
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 451
- 试验地点
- 33
- 主要终点
- Survival Without BPD at 36 Weeks
研究概览
简要总结
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.
详细描述
Multi-center, double blind, placebo-controlled, randomized clinical trial. Infants who meet all enrollment criteria at any point during days 5 to 14 after birth will be randomized to inhaled NO starting at 20 ppm, or matching placebo, by means of a blinded INOvent® delivery device. All infants will receive 24 days of therapy, following a dose reduction schedule. Infants who are extubated before 24 days will continue therapy via nasal continuous positive airway pressure (CPAP) or nasal cannula to complete 24 days' of therapy. The primary outcome measure will be survival without BPD at 36 weeks gestational age using a physiologic assessment of BPD.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants who are:
- •500 to 1250 grams at birth
- •< 30 weeks gestational age
- •5 to 14 days of age (inclusive) at the time of entry
- •Requiring mechanical ventilation or for those infants ≤ 800 grams, positive pressure support (including CPAP) for respiratory insufficiency on days 5 to 14 days of age (inclusive)
排除标准
- •Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care
- •Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)
- •Subjects who are dependent on right to left shunting to maintain the systemic circulation
- •Preterm infants who received prior iNO therapy
- •Use of another investigational agent
研究组 & 干预措施
Inhaled Nitric Oxide
Inhaled Nitric Oxide
干预措施: Inhaled Nitric Oxide (Drug)
Placebo
Nitrogen Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Survival Without BPD at 36 Weeks
时间窗: Baseline, 36 weeks PMA
次要结局
- Days of Airway Pressure Support - Intent-to-treat Population(Through hospital discharge, an average of 105 days for placebo and 108 days for INO)
- Length of Birth Hospitalization(Through hospital discharge, an average of 105 days for placebo and 108 days for INO)
- Number of Days of Oxygen Use(Through hospital discharge, an average of 105 days for placebo and 108 days for INO)
- Severity of Bronchopulmonary Dysplasia(36 weeks)
- Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia(Through hospital discharge, an average of 105 days for placebo and 108 days for INO)
- Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason(Through hospital discharge, an average of 105 days for placebo and 108 days for INO)
- Systemic Use of Postnatal Corticosteroids for Any Medical Reason(Through hospital discharge, an average of 105 days for placebo and 108 days for INO)