Background Inhaled nitric oxide improves gas exchange, decreasespulmonary vascular lability, and reduces pulmonary inflammation.We hypothesized that the use of inhaled nitric oxide would decreasethe incidence of chronic lung disease and death in prematureinfants with the respiratory distress syndrome.
Methods We conducted a randomized, double-blind, placebo-controlledstudy of the effect of inhaled nitric oxide during the firstweek of life on the incidence of chronic lung disease and deathin premature infants (less than 34 weeks' gestation) who wereundergoing mechanical ventilation for the respiratory distresssyndrome. Infants were randomly assigned to receive inhalednitric oxide (10 ppm on day 1, followed by 5 ppm for six days)or inhaled oxygen placebo for seven days. We further randomlyassigned the infants in each group to receive intermittent mandatoryor high-frequency oscillatory ventilation.
Results A total of 207 premature infants were enrolled. In thegroup given inhaled nitric oxide, 51 infants (48.6 percent)died or had chronic lung disease, as compared with 65 infants(63.7 percent) in the placebo group (relative risk, 0.76; 95percent confidence interval, 0.60 to 0.97; P=0.03). There wasno significant difference between the nitric oxide and placebogroups in the overall incidence of intraventricular hemorrhageand periventricular leukomalacia (33.3 percent and 38.2 percent,respectively), but the group given inhaled nitric oxide hada lower incidence of severe intraventricular hemorrhage andperiventricular leukomalacia (12.4 percent vs. 23.5 percent;relative risk, 0.53; 95 percent confidence interval, 0.28 to0.98; P=0.04). The type of ventilation had no significant effecton the outcome.
Conclusions The use of inhaled nitric oxide in premature infantswith the respiratory distress syndrome decreases the incidenceof chronic lung disease and death.
Source Information
From the Departments of Pediatrics (M.D.S., K.G.-M., J.D.M., G.L., P.S.) and Health Studies (D.H.), University of Chicago, Chicago.
Address reprint requests to Dr. Schreiber at the University of Chicago, MC 6060, 5841 S. Maryland Ave., Chicago, IL 60637, or at mschreiber{at}peds.bsd.uchicago.edu.
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