Document Detail


Effects of prophylactic indomethacin in extremely low-birth-weight infants with and without adequate exposure to antenatal corticosteroids.
MedLine Citation:
PMID:  21727276     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To examine whether treatment with antenatal corticosteroids modifies the immediate and long-term effects of prophylactic indomethacin sodium trihydrate in extremely low-birth-weight infants.
DESIGN: Post hoc subgroup analysis of data from the Trial of Indomethacin Prophylaxis in Preterms.
SETTING: Thirty-two neonatal intensive care units in Canada, the United States, Australia, New Zealand, and Hong Kong.
PARTICIPANTS: A total of 1195 infants with birth weights of 500 to 999 g and known exposure to antenatal corticosteroids. We defined as adequate any exposure to antenatal corticosteroids that occurred at least 24 hours before delivery.
INTERVENTION: Indomethacin or placebo intravenously once daily for the first 3 days.
OUTCOME MEASURES: Death or survival to 18 months with cerebral palsy, cognitive delay, severe hearing loss, or bilateral blindness; severe periventricular and intraventricular hemorrhage; patent ductus arteriosus; and surgical closure of a patent ductus arteriosus.
RESULTS: Of the 1195 infants in this analysis cohort, 670 had adequate and 525 had inadequate exposure to antenatal corticosteroids. There was little statistical evidence of heterogeneity in the effects of prophylactic indomethacin between the subgroups for any of the outcomes. The adjusted P values for interaction were as low as .15 for the outcome of death or impairment at 18 months and as high as .80 for the outcome of surgical duct closure.
CONCLUSION: We find little evidence that the effects of prophylactic indomethacin vary in extremely low-birth-weight infants with and without adequate exposure to antenatal corticosteroids. Trial Registration clinicaltrials.gov Identifier: NCT00009646.
Authors:
Barbara Schmidt; Mary Seshia; Seetha Shankaran; Lindsay Mildenhall; Jon Tyson; Kei Lui; Tai Fok; Robin Roberts;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Archives of pediatrics & adolescent medicine     Volume:  165     ISSN:  1538-3628     ISO Abbreviation:  Arch Pediatr Adolesc Med     Publication Date:  2011 Jul 
Date Detail:
Created Date:  2011-07-05     Completed Date:  2011-09-22     Revised Date:  2014-09-24    
Medline Journal Info:
Nlm Unique ID:  9422751     Medline TA:  Arch Pediatr Adolesc Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  642-6     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00009646
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MeSH Terms
Descriptor/Qualifier:
Adrenal Cortex Hormones / therapeutic use*
Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
Developmental Disabilities / prevention & control*
Female
Humans
Indomethacin / therapeutic use*
Infant, Extremely Low Birth Weight*
Infant, Newborn
Infant, Premature, Diseases / prevention & control*
Male
Prenatal Care
Treatment Outcome
Grant Support
ID/Acronym/Agency:
M01 RR 00070/RR/NCRR NIH HHS; M01 RR 00997/RR/NCRR NIH HHS; M01 RR000070/RR/NCRR NIH HHS; M01 RR000070-37/RR/NCRR NIH HHS; M01 RR000997-24/RR/NCRR NIH HHS; U10 HD021364/HD/NICHD NIH HHS; U10 HD021364-21/HD/NICHD NIH HHS; U10 HD021373-22/HD/NICHD NIH HHS; U10 HD021385/HD/NICHD NIH HHS; U10 HD021385-14/HD/NICHD NIH HHS; U10 HD027851-16/HD/NICHD NIH HHS; U10 HD027880/HD/NICHD NIH HHS; U10 HD027880-09/HD/NICHD NIH HHS; U10 HD027881-09/HD/NICHD NIH HHS; U10 HD027904/HD/NICHD NIH HHS; U10 HD027904-09/HD/NICHD NIH HHS; U10 HD034216/HD/NICHD NIH HHS; U10 HD034216-04/HD/NICHD NIH HHS; U10 HD21364/HD/NICHD NIH HHS; U10 HD21373/HD/NICHD NIH HHS; U10 HD21385/HD/NICHD NIH HHS; U10 HD27851/HD/NICHD NIH HHS; U10 HD27880/HD/NICHD NIH HHS; U10 HD27881/HD/NICHD NIH HHS; U10 HD27904/HD/NICHD NIH HHS; U10 HD34216/HD/NICHD NIH HHS; UL1 RR025008/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Adrenal Cortex Hormones; 0/Anti-Inflammatory Agents, Non-Steroidal; XXE1CET956/Indomethacin
Investigator
Investigator/Affiliation:
A Solimano / ; M Whitfield / ; F Germain / ; J Tomlinson / ; A Peliowski / ; P Etches / ; B Young / ; C M T Robertson / ; D McMillan / ; R Sauve / ; L Bourcier / ; H Christianson / ; K Sankaran / ; B Andreychuk / ; M Seshia / ; O Casiro / ; V Debooy / ; V Cook / ; C M G Cronin / ; D Moddemann / ; N Granke / ; C Nwaesei / ; L St Aubin / ; D Reid / ; D Lee / ; C Kenyon / ; L Whitty / ; J Farrell / ; B Schmidt / ; S Saigal / ; P Gillie / ; J Dix / ; B Zhang / ; A Ohlsson / ; E Asztalos / ; L Wiley / ; A James / ; K F W Young Tai / ; M Clarke / ; M Vincer / ; S Stone / ; R Kohan / ; N French / ; H Benninger / ; C Barnett / ; R Haslam / ; J Ramsay / ; P Davis / ; L Doyle / ; B Faber / ; K Callanan / ; S Fraser / ; K Lui / ; M Rochefort / ; E McAvoy / ; P Colditz / ; M Pritchard / ; P Steer / ; D I Tudehope / ; V Flenady / ; J Hegarty / ; L Mildenhall / ; W Smith / ; L McCarthy / ; T Fok / ; D K Stevenson / ; B Fleisher / ; B Ball / ; L A Papile / ; G Laadt / ; C Backstrom / ; J Tyson / ; S Broyles / ; S Madison / ; W A Carlo / ; K Nelson / ; M Collins / ; S Johnson / ; S Shankaran / ; V Delaney-Black / ; G Muran / ; D Driscoll / ; B J Stoll / ; N Simon / ; E Hale / ; A A Fanaroff / ; D Wilson / ; M Hack / ; N Newman / ; C R Bauer / ; A M Worth / ; W Griffin / ; W Oh / ; B R Vohr / ; A Hensman / ; B Schmidt / ; P Davis / ; D Moddemann / ; A Ohlsson / ; R Roberts / ; S Saigal / ; A Solimano / ; M Vincer / ; L Wright / ; M Gent / ; W Fraser / ; M Perlman / ; R Adkins / ; L Elden / ; C M T Robertson / ; B R Vohr / ; S Gray / ; R Roberts / ; K Thorpe / ; N LaPierre /
Comments/Corrections

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