The Use of Inhaled Nitric Oxide to Improve Respiratory Outcomes in Late Preterm Infants
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life
研究概览
简要总结
The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36 weeks and who require breathing support with high flow nasal cannula, nasal continuous positive airway pressure, or nasal intermittent positive pressure will be randomized to receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol until all respiratory support has been discontinued. Infants will be followed to evaluate safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<48 hours of age,
- •30 - 36 weeks gestational age at birth based on best estimate using obstetrical sonography (first or second trimester), solid dating criteria, or Ballard examination,
- •Birth weight of ≥ 1,000 g,
- •5 minute Apgar score ≥5,
- •Requiring nasal cannula O2 > 1 liter per minute (LPM), continuous positive pressure (CPAP), or non invasive positive pressure ventilation (NIPPV) for treatment of respiratory failure,
- •Requiring a fraction of inspired oxygen (FIO2) of at least 0.25 to maintain arterial oxygen saturation (SaO2) 88-94%,
- •Parent or guardian has signed informed consent and agrees to all study- related procedures, including those required after hospital discharge.
排除标准
- •Major congenital anomaly
- •Intubation and surfactant in the delivery room or prior to enrollment in the Neonatal Intensive Care Unit (NICU). Excludes intubation for suctioning.
- •Known congenital infection (bacterial, viral),
- •Perinatal asphyxia (5 minute Apgar <5, umbilical artery pH < 7.0 or evidence of neonatal encephalopathy),
- •Mother and/or infant is enrolled in another clinical trial (excluding observational) or has received an investigational drug,
- •Has undergone or is anticipated to require a major surgical procedure within the first 48 h of life,
- •Any condition which could preclude receiving study drug or performing any study-related procedures,
- •Use of postnatal corticosteroids,
- •Parent or guardian is unable or unwilling to complete study procedures after hospital discharge.
研究组 & 干预措施
inhaled Nitric Oxide
iNO to start at 20 parts per million (ppm) for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
干预措施: inhaled nitric oxide (Drug)
Nitrogen Gas
Placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
干预措施: Placebo Comparator - nitrogen gas (Drug)
结局指标
主要结局
Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life
时间窗: 7 days
次要结局
- Total Duration of Respiratory Support(From hospital admission through discharge)
- Total Length of Hospital Stay(From hospital admission through discharge)
- Number of Participants Who Had the Need for Exogenous Surfactant(7 days)
- Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA)(12 months corrected gestational age)
- Total Duration of Supplemental Oxygen(From Hospital Admission through discharge)
- Diagnosis of Bronchopulmonary Dysplasia (BPD)(At 36 weeks postmenstrual age or 1-2month of age)