Document Detail


Two-year neurodevelopmental outcomes of ventilated preterm infants treated with inhaled nitric oxide.
MedLine Citation:
PMID:  20138299     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: In a randomized multi-center trial, we demonstrated that inhaled nitric oxide begun between 7 and 21 days and given for 24 days significantly increased survival without bronchopulmonary dysplasia (BPD) in ventilated premature infants weighing <1250 g. Because some preventative BPD treatments are associated with neurodevelopmental impairment, we designed a follow-up study to assess the safety of nitric oxide.
STUDY DESIGN: 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.
RESULTS: 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.
CONCLUSIONS: Inhaled nitric oxide improved survival free of BPD, with no adverse neurodevelopmental effects at 2 years of age.
Authors:
Michele C Walsh; Anna Maria Hibbs; Camilia R Martin; Avital Cnaan; Roberta L Keller; Eric Vittinghoff; Richard J Martin; William E Truog; Philip L Ballard; Arlene Zadell; Sandra R Wadlinger; Christine E Coburn; Roberta A Ballard;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2010-02-06
Journal Detail:
Title:  The Journal of pediatrics     Volume:  156     ISSN:  1097-6833     ISO Abbreviation:  J. Pediatr.     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2010-03-22     Completed Date:  2010-04-29     Revised Date:  2011-09-26    
Medline Journal Info:
Nlm Unique ID:  0375410     Medline TA:  J Pediatr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  556-61.e1     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2010 Mosby, Inc. All rights reserved.
Affiliation:
Case Western Reserve University, Cleveland, OH, USA. mcw3@po.cwru.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00000548
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MeSH Terms
Descriptor/Qualifier:
Administration, Inhalation
Bronchopulmonary Dysplasia / epidemiology,  etiology,  prevention & control*
Developmental Disabilities / epidemiology,  etiology,  prevention & control*
Female
Follow-Up Studies
Free Radical Scavengers / administration & dosage*
Humans
Incidence
Infant
Infant, Newborn
Infant, Premature*
Male
Nitric Oxide / administration & dosage*
Prospective Studies
Respiratory Distress Syndrome, Newborn / complications,  drug therapy*
Risk Factors
Survival Rate
Time Factors
Treatment Outcome
United States / epidemiology
Grant Support
ID/Acronym/Agency:
HD26979/HD/NICHD NIH HHS; K23 HD056299/HD/NICHD NIH HHS; M01 RR000040-38A10715/RR/NCRR NIH HHS; M01 RR000080-421044/RR/NCRR NIH HHS; M01 RR000240-370552/RR/NCRR NIH HHS; M01 RR000240-400637/RR/NCRR NIH HHS; M01-RR00064/RR/NCRR NIH HHS; M01-RR00080/RR/NCRR NIH HHS; M01-RR00084/RR/NCRR NIH HHS; M01-RR001271/RR/NCRR NIH HHS; M01-RR00240/RR/NCRR NIH HHS; M01-RR00425/RR/NCRR NIH HHS; P30 HD026979-089006/HD/NICHD NIH HHS; P30-HD26979/HD/NICHD NIH HHS; P50 HL056401-079001/HL/NHLBI NIH HHS; P50-HL56401/HL/NHLBI NIH HHS; U01 HL062514-01A1/HL/NHLBI NIH HHS; U01-HL62514/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Free Radical Scavengers; 10102-43-9/Nitric Oxide
Investigator
Investigator/Affiliation:
D Durand / ; J Asselin / ; L Pacello / ; R Ratcliff / ; V Daly / ; A Espinoza / ; E Eichenwald / ; K Puopolo / ; A Hansen / ; T Cimini / ; D Beadles / ; C Pantano / ; A Puri / ; W Bunuan / ; A Verne / ; J Raber / ; S Sehgal / ; J Merrill / ; L Corcoran / ; J Fricko / ; S Zirin / ; A Hedgman / ; K Kelly / ; B Hubble / ; K Mooney / ; L Brown / ; R Scarborough / ; J Bernbaum / ; H Hurt / ; D Mayock / ; C Gleason / ; S Jacques / ; H Meo / ; F Bennett / ; I Ekekezie / ; C Castor / ; P Johnson / ; K Meinert / ; D Taylor / ; H Kilbride / ; S Welty / ; S Farley / ; T Preston / ; C Timan / ; D Stewart / ; S Daugherty / ; J Foos / ; K Sheeley / ; S Polston / ; S Wilkerson / ; S Courtney / ; A Steele / ; D Potak / ; B Wilkens / ; S Pollard / ; A Adesman / ; D Null / ; R Milley / ; S Baker / ; L Cole / ; K Hillier / ; L Hiatt / ; A Bodnar / ; M Tracy / ; J Di Fiore / ; M Hack / ; D Wilson-Costello / ; M Hudak / ; S Osbeck / ; A Kellum / ; L Hogans / ; D Childers / ; R Phibbs / ; S Sehring / ; J Imamura-Ching / ; N Newton / ; C Kelly / ; R Piecuch / ; S Golembek / ; L Parton / ; N Dweck / ; J Weissleder / ; J Kase / ; X Luan / ; T Alvarado-Taylor / ; J Valliyil / ; M Davis / ; K Gibbs / ; T Hazinski / ; A Fleischman / ; F Morin / ; B Vohr / ; S Carter / ; M Berberich / ; N Geller / ; C Hunt / ; G Zheng / ; R Ballard / ; W Truog / ; R Martin / ; P Ballard / ; J Merrill / ; M Walsh /
Comments/Corrections

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