Document Detail

Neurodevelopmental outcomes of premature infants with severe respiratory failure enrolled in a randomized controlled trial of inhaled nitric oxide.
MedLine Citation:
PMID:  17586184     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: We hypothesized that inhaled nitric oxide (iNO) would not decrease death or neurodevelopmental impairment (NDI) in infants enrolled in the National Institute of Child Health and Human Development Preemie iNO Trial (PiNO) trial, nor improve neurodevelopmental outcomes in the follow-up group.
STUDY DESIGN: Infants <34 weeks of age, weighing <1500 g, with severe respiratory failure were enrolled in the multicenter, randomized, controlled trial. NDI at 18 to 22 months corrected age was defined as: moderate to severe cerebral palsy (CP; Mental Developmental Index or Psychomotor score Developmental Index <70), blindness, or deafness.
RESULTS: Of 420 patients enrolled, 109 who received iNO (52%) and 98 who received placebo (47%) died. The follow-up rate in survivors was 90%. iNO did not reduce death or NDI (78% versus 73%; relative risk [RR], 1.07; 95% CI, 0.95-1.19), or NDI or Mental Developmental Index <70 in the follow-up group. Moderate-severe CP was slightly higher with iNO (RR, 2.41; 95% CI, 1.01-5.75), as was death or CP in infants weighing <1000 g (RR, 1.22; 95% CI, 1.05-1.43).
CONCLUSIONS: In this extremely ill cohort, iNO did not reduce death or NDI or improve neurodevelopmental outcomes. Routine iNO use in premature infants should be limited to research settings until further data are available.
Susan R Hintz; Krisa P Van Meurs; R Perritt; W Kenneth Poole; Abhik Das; David K Stevenson; Richard A Ehrenkranz; James A Lemons; Betty R Vohr; Roy Heyne; David O Childers; Myriam Peralta-Carcelen; Anna Dusick; Yvette R Johnson; Brenda Morris; Robert Dillard; Yvonne Vaucher; Jean Steichen; Ira Adams-Chapman; Ganesh Konduri; Gary J Myers; Marissa de Ungria; Jon E Tyson; Rosemary D Higgins;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of pediatrics     Volume:  151     ISSN:  1097-6833     ISO Abbreviation:  J. Pediatr.     Publication Date:  2007 Jul 
Date Detail:
Created Date:  2007-06-25     Completed Date:  2007-07-23     Revised Date:  2014-09-24    
Medline Journal Info:
Nlm Unique ID:  0375410     Medline TA:  J Pediatr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  16-22, 22.e1-3     Citation Subset:  AIM; IM    
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MeSH Terms
Administration, Inhalation
Chi-Square Distribution
Child Development / drug effects
Developmental Disabilities / prevention & control
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Follow-Up Studies
Infant, Newborn
Infant, Premature*
Nervous System / drug effects,  growth & development*
Nitric Oxide / administration & dosage*
Poisson Distribution
Respiratory Distress Syndrome, Newborn / diagnosis,  drug therapy*,  mortality*
Risk Assessment
Severity of Illness Index
Statistics, Nonparametric
Survival Rate
Treatment Outcome
Grant Support
M01 RR000044/RR/NCRR NIH HHS; M01 RR000044-430747/RR/NCRR NIH HHS; M01 RR000070/RR/NCRR NIH HHS; M01 RR000070-445286/RR/NCRR NIH HHS; M01 RR000750-330837/RR/NCRR NIH HHS; M01 RR006022-14/RR/NCRR NIH HHS; M01 RR008084-13/RR/NCRR NIH HHS; U01 HD036790-07/HD/NICHD NIH HHS; U10 HD021373-22/HD/NICHD NIH HHS; U10 HD021385/HD/NICHD NIH HHS; U10 HD021385-21/HD/NICHD NIH HHS; U10 HD027851-16/HD/NICHD NIH HHS; U10 HD027853-15/HD/NICHD NIH HHS; U10 HD027856-15/HD/NICHD NIH HHS; U10 HD027871-17/HD/NICHD NIH HHS; U10 HD027880-16/HD/NICHD NIH HHS; U10 HD027904/HD/NICHD NIH HHS; U10 HD027904-15S2/HD/NICHD NIH HHS; U10 HD034216/HD/NICHD NIH HHS; U10 HD034216-11/HD/NICHD NIH HHS; U10 HD040461-05/HD/NICHD NIH HHS; U10 HD040498-05/HD/NICHD NIH HHS; U10 HD040521/HD/NICHD NIH HHS; U10 HD040521-05/HD/NICHD NIH HHS; U10 HD040689/HD/NICHD NIH HHS; U10 HD040689-02/HD/NICHD NIH HHS
Reg. No./Substance:
31C4KY9ESH/Nitric Oxide

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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