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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
3
Tufts Medical Center
Boston, Massachusetts, United States
Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life
Time frame: 7 days
Number of Participants Who Had the Need for Exogenous Surfactant
Time frame: 7 days
Total Length of Hospital Stay
participants who were followed for the duration of hospital stay
Time frame: From hospital admission through discharge
Total Duration of Supplemental Oxygen
Participants were followed for the duration of hospital stay for use of supplemental oxygen
Time frame: From Hospital Admission through discharge
Diagnosis of Bronchopulmonary Dysplasia (BPD)
Diagnosis of BPD by oxygen challenge test at 36 weeks post menstrual age (PMA) for infants born between 30 and 32 weeks gestational age (GA). For those born 32 1/7 - 36 weeks, an oxygen challenge test was performed at 1-2 months of age.
Time frame: At 36 weeks postmenstrual age or 1-2month of age
Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA)
defined by a validated system of parental diaries and pulmonary questionnaires, as well as review of medical records (medical visits, respiratory medication use, emergency room visits, and hospital re-admissions)
Time frame: 12 months corrected gestational age
Total Duration of Respiratory Support
participants were followed for the duration of hospital stay for respiratory support
Time frame: From hospital admission through discharge
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