Inhaled nitric oxide in premature infants with the respiratory distress syndrome.
BACKGROUND
Inhaled nitric oxide improves gas exchange, decreases pulmonary vascular lability, and reduces pulmonary inflammation. We hypothesized that the use of inhaled nitric oxide would decrease the incidence of chronic lung disease and death in premature infants with the respiratory distress syndrome.


METHODS
We conducted a randomized, double-blind, placebo-controlled study of the effect of inhaled nitric oxide during the first week of life on the incidence of chronic lung disease and death in premature infants (less than 34 weeks' gestation) who were undergoing mechanical ventilation for the respiratory distress syndrome. Infants were randomly assigned to receive inhaled nitric oxide (10 ppm on day 1, followed by 5 ppm for six days) or inhaled oxygen placebo for seven days. We further randomly assigned the infants in each group to receive intermittent mandatory or high-frequency oscillatory ventilation.


RESULTS
A total of 207 premature infants were enrolled. In the group 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; 95 percent confidence interval, 0.60 to 0.97; P=0.03). There was no significant difference between the nitric oxide and placebo groups in the overall incidence of intraventricular hemorrhage and periventricular leukomalacia (33.3 percent and 38.2 percent, respectively), but the group given inhaled nitric oxide had a lower incidence of severe intraventricular hemorrhage and periventricular leukomalacia (12.4 percent vs. 23.5 percent; relative risk, 0.53; 95 percent confidence interval, 0.28 to 0.98; P=0.04). The type of ventilation had no significant effect on the outcome.


CONCLUSIONS
The use of inhaled nitric oxide in premature infants with the respiratory distress syndrome decreases the incidence of chronic lung disease and death.
Schreiber
Michael D
MD
Department of Pediatrics, University of Chicago, Chicago, IL 60637, USA. mschreiber@peds.bsd.uchicago.edu
Gin-Mestan
Karen
K
Marks
Jeremy D
JD
Huo
Dezheng
D
Lee
Grace
G
Srisuparp
Pimol
P
D000280:Administration, Inhalation; D001724:Birth Weight; D001997:Bronchopulmonary Dysplasia / Q000453:epidemiology / Q000517:prevention & control*; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D020300:Intracranial Hemorrhages / Q000453:epidemiology / Q000517:prevention & control; D007969:Leukomalacia, Periventricular / Q000453:epidemiology / Q000517:prevention & control; D008171:Lung Diseases / Q000453:epidemiology / Q000517:prevention & control; D008297:Male; D009569:Nitric Oxide / Q000008:administration & dosage / Q000627:therapeutic use*; D010102:Oxygen Inhalation Therapy; D012121:Respiration, Artificial / Q000379:methods; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy
D009569:Nitric Oxide