Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants
Bronchopulmonary Dysplasia
About this trial
This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring Inhaled Nitric Oxide, Bronchopulmonary Dysplasia, Late Prematurity, Chronic Respiratory Morbidity
Eligibility Criteria
Inclusion Criteria:
- <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.
Exclusion Criteria:
- 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.
Sites / Locations
- Tufts Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
inhaled Nitric Oxide
Nitrogen Gas
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.
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.