Conditions: Bronchopulmonary Dysplasia
Keywords: Inhaled Nitric Oxide Bronchopulmonary Dysplasia Late Prematurity Chronic Respiratory Morbidity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: inhaled nitric oxide intervention 2: Placebo Comparator - nitrogen gas
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: