Sepsis Clinical Trial
Official title:
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
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.
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