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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
420
Started at 5 ppm and could be increased to 10 ppm
Started at 5 ppm and could be increased to 10 ppm
University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Death or Bronchopulmonary Dysplasia
Time frame: At 36 weeks post-conceptional age
Intraventricular Hemorrhage Grade III and IV
Time frame: At 36 weeks post-conceptional age
Days on assisted ventilation
Time frame: At 36 weeks post-conceptional age
Length of hospitalization
Time frame: At hospital discharge
Retinopathy of prematurity
Time frame: At hospital discharge
Air leaks
Time frame: At 36 weeks post-conceptual age
Days on oxygen
Time frame: At 36 weeks post-conceptual age
Supplemental oxygen
Time frame: At 36 weeks post-conceptual age
Neurodevelopmental outcome
Time frame: 18-22 months corrected age
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University of California at San Diego
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
University of Florida
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Wayne State University
Detroit, Michigan, United States
University of Rochester
Rochester, New York, United States
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