Child health status, neurodevelopmental outcome, and parental satisfaction in a randomized, controlled trial of nitric oxide for persistent pulmonary hypertension of the newborn.
OBJECTIVE
To describe health and neurodevelopmental outcomes and parental satisfaction with hospital care among surviving intervention and control enrollees in a randomized, controlled trial of nitric oxide for persistent pulmonary hypertension of the newborn (PPHN).


METHODS
All surviving enrollees 1 to 4 years of age were eligible for follow-up. Outcomes were assessed by telephone using a trained interviewer and standardized instruments. Domains assessed included parental report of specific conditions and hospital use, rating of general health, cognitive and motor 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 families (22%) could not be located, 2 (2%) were non-English-speaking, and 3 (4%) declined participation. No postdischarge deaths were ascertained. Among those interviewed, race, income, and education of parents of intervention and controls were comparable, as were entry oxygenation index, extracorporeal oxygenation utilization, and days of hospitalization. No differences were found in pulmonary, neurologic, cognitive, behavioral, or neurosensory outcomes; 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 satisfaction expressed were high for each group. No differences in parental ratings were found between the 2 groups.


CONCLUSIONS
No adverse health or neurodevelopmental outcomes have been observed 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 received 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.
Ellington
M
M
Department of Pediatrics, New York Hospital Medical Center of Queens, New York, New York, USA. mae9011@nyp.org
O'Reilly
D
D
Allred
E N
EN
McCormick
M C
MC
Wessel
D L
DL
Kourembanas
S
S
D000328:Adult; D001294:Attitude to Health; D002648:Child; D002675:Child, Preschool; D003695:Delivery of Health Care / Q000592:standards; D002658:Developmental Disabilities / Q000453:epidemiology; D005500:Follow-Up Studies; D006304:Health Status; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D009422:Nervous System Diseases / Q000453:epidemiology; D009569:Nitric Oxide / Q000627:therapeutic use*; D010290:Parents / Q000523:psychology*; D010547:Persistent Fetal Circulation Syndrome / Q000188:drug therapy* / Q000453:epidemiology; D010549:Personal Satisfaction; D012678:Sensation Disorders / Q000453:epidemiology; D016896:Treatment Outcome
D009569:Nitric Oxide