Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
- Conditions
- Respiratory Distress Syndrome (RDS)Infant, Low Birth WeightInfant, Small for Gestational AgeInfant, PrematurePneumoniaHypertension, PulmonaryInfant, NewbornSepsis
- Interventions
- Drug: PlaceboDrug: Inhaled nitric oxide
- Registration Number
- NCT00016523
- Lead Sponsor
- NICHD Neonatal Research Network
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 420
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo Inhaled Oxygen Inhaled Nitric Oxide Inhaled nitric oxide Inhaled Nitric Oxide
- Primary Outcome Measures
Name Time Method Death or Bronchopulmonary Dysplasia At 36 weeks post-conceptional age
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (17)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Stanford University
🇺🇸Palo Alto, California, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Wake Forest University
🇺🇸Charlotte, North Carolina, United States
Brown University, Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Florida
🇺🇸Jacksonville, Florida, United States
University of Rochester
🇺🇸Rochester, New York, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of California at San Diego
🇺🇸San Diego, California, United States
University of Miami
🇺🇸Miami, Florida, United States
RTI International
🇺🇸Durham, North Carolina, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Cincinnati Children's Medical Center
🇺🇸Cincinnati, Ohio, United States