Early inhaled nitric oxide therapy for term and near-term newborn infants with hypoxic respiratory failure: neurodevelopmental follow-up. J Pediatr 2007 Mar;150(3):235-40, 240.e1
Date
02/20/2007Pubmed ID
17307536Pubmed Central ID
PMC1906720DOI
10.1016/j.jpeds.2006.11.065Scopus ID
2-s2.0-33847310762 (requires institutional sign-in at Scopus site) 88 CitationsAbstract
OBJECTIVE: To report the neurodevelopmental outcome of infants enrolled in a randomized multicenter trial of early inhaled nitric oxide (iNO) in term and near-term neonates with hypoxic respiratory failure and pulmonary hypertension.
STUDY DESIGN: Neonates born at > or = 34 weeks gestation who required assisted ventilation and had an oxygenation index > or = 15 and < 25 were randomized to an early iNO group or a control group. A comprehensive neurodevelopmental assessment of survivors was performed at age 18 to 24 months.
RESULTS: The trial enrolled 299 infants, of which 266 (89%) survived to age 18 to 24 months (136 in the early iNO group and 130 in the control group). Follow-up evaluations were done on 234 (88%) of surviving infants. There were no differences between the 2 groups in the incidence of neurodevelopmental impairment (early iNO, 27%; control, 25%) and hearing impairment (early iNO, 23%; control, 24%). Mental development index scores were similar in the 2 groups; however, psychomotor developmental index scores were significantly higher in the control group (early iNO, 89 +/- 17.7; control, 93.5 +/- 18.4).
CONCLUSIONS: Early iNO therapy for hypoxic respiratory failure in term and near-term infants is not associated with an increase in neurodevelopmental impairment or hearing loss at 18 to 24 months postnatal age.
Author List
Konduri GG, Vohr B, Robertson C, Sokol GM, Solimano A, Singer J, Ehrenkranz RA, Singhal N, Wright LL, Van Meurs K, Stork E, Kirpalani H, Peliowski A, Johnson Y, Neonatal Inhaled Nitric Oxide Study GroupAuthor
Girija Ganesh Konduri MD Chief, Professor in the Pediatrics department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Administration, InhalationCentral Nervous System
Confidence Intervals
Developmental Disabilities
Double-Blind Method
Female
Follow-Up Studies
Gestational Age
Humans
Incidence
Infant
Infant, Newborn
Infant, Premature
Male
Nitric Oxide
Probability
Prospective Studies
Reference Values
Respiratory Distress Syndrome, Newborn
Risk Assessment
Severity of Illness Index
Survival Rate
Term Birth
Treatment Outcome