Child health status, neurodevelopmental outcome, and parental satisfactionin a randomized, controlled trial of nitric oxide for persistent pulmonaryhypertension of the newborn

Objective. To describe health and neurodevelopmental outcomes and parental satisfaction with hospital care among surviving intervention and control en rollees in a randomized, controlled trial of nitric oxide for persistent pu lmonary hypertension of the newborn (PPHN). Methods. All surviving enrollees 1 to 4 years of age were eligible for foll ow-up. Outcomes were assessed by telephone using a trained interviewer and standardized instruments. Domains assessed included parental report of spec ific conditions and hospital use, rating of general health, cognitive and m otor development, behavior problems, temperament, and satisfaction with the hospital stay. Fisher's exact test and the Wilcoxon rank sum test assessed differences between intervention and control infants. Results. Interviews were completed on 60 of 83 survivors (72%). Eighteen fa milies (22%) could not be located, 2 (2%) were non-English-speaking, and 3 (4%) declined participation. No postdischarge deaths were ascertained. Amon g those interviewed, race, income, and education of parents of intervention and controls were comparable, as were entry oxygenation index, extracorpor eal oxygenation utilization, and days of hospitalization. No differences we re found in pulmonary, neurologic, cognitive, behavioral, or neurosensory o utcomes; hospital readmission rates; or parental ratings of child's health. The overall neurologic handicap rate was 15%. The rate of hearing deficit was 7%. The rate of significant behavioral problems was 26%. Levels of sati sfaction expressed were high for each group. No differences in parental rat ings were found between the 2 groups. Conclusions. No adverse health or neurodevelopmental outcomes have been obs erved among infants treated with nitric oxide for PPHN. The parents of the critically ill infants enrolled in our clinical trial welcomed their child' s inclusion and all expressed satisfaction with the care that their child r eceived while at a tertiary care hospital. Enrollment in either arm of this randomized, controlled trial did not seem to affect parental satisfaction with the hospital care that their child received.