Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
Overview
- Phase
- Phase 3
- Intervention
- Inhaled nitric oxide
- Conditions
- Infant, Newborn
- Sponsor
- NICHD Neonatal Research Network
- Enrollment
- 420
- Locations
- 17
- Primary Endpoint
- Death or Bronchopulmonary Dysplasia
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.
Detailed Description
This multicenter, randomized, double-masked, controlled clinical trial evaluated the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with respiratory failure secondary to respiratory distress syndrome (RDS), sepsis/pneumonia, aspiration syndrome, idiopathic pulmonary hypertension and/or suspected pulmonary hypoplasia. Infants were followed until death or discharge to home. The trial compared iNO therapy to mock gas delivery as the control, and otherwise incorporated conventional management strategies (including treatment with surfactant and high frequency ventilation as adjuncts to iNO therapy). During the initial dosing, iNO was started at 5 ppm and could be increased to 10 ppm. If the infant did not respond, study gas was discontinued. For infants who responded to study gas, a gradual weaning was initiated. The total exposure to study gas did not exceed 336 hours (14 days). Infants were monitored for signs of toxicity. Medical and neurodevelopmental outcome of surviving infants were assessed at 18 to 22 months corrected age by masked, certified examiners.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Inhaled Nitric Oxide
Inhaled Nitric Oxide
Intervention: Inhaled nitric oxide
Placebo
Inhaled Oxygen
Intervention: Placebo
Outcomes
Primary Outcomes
Death or Bronchopulmonary Dysplasia
Time Frame: At 36 weeks post-conceptional age
Secondary Outcomes
- Neurodevelopmental outcome(18-22 months corrected age)
- Intraventricular Hemorrhage Grade III and IV(At 36 weeks post-conceptional age)
- Days on assisted ventilation(At 36 weeks post-conceptional age)
- Retinopathy of prematurity(At hospital discharge)
- Days on oxygen(At 36 weeks post-conceptual age)
- Supplemental oxygen(At 36 weeks post-conceptual age)
- Air leaks(At 36 weeks post-conceptual age)
- Length of hospitalization(At hospital discharge)