Our hypothesis was that inhaled nitric oxide would not increase neurodevelopmental impairment compared with placebo. We prospectively evaluated neurodevelopmental and growth outcomes at 24 months postmenstrual age in 477 of 535 surviving infants (89 % ) enrolled in the trial.
In the treated group, 109 of 243 children (45 % ) had neurodevelopmental impairment (moderate or severe cerebral palsy, bilateral blindness, bilateral hearing loss, or score <70 on the Bayley Scales II), compared with 114 of 234 (49 % ) in the placebo group (relative risk, 0.92; 95 % CI, 0.75-1.12; P = .39). No differences on any subcomponent of neurodevelopmental impairment or growth variables were found between inhaled nitric oxide or placebo.
Inhaled nitric oxide improved survival free of BPD, with no adverse neurodevelopmental effects at 2 years of age.