Document Detail


Early CPAP versus surfactant in extremely preterm infants.
MedLine Citation:
PMID:  20472939     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants.
METHODS: We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30% oxygen).
RESULTS: A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7% and 54.1%, respectively; relative risk with CPAP, 0.91; 95% CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups.
CONCLUSIONS: The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants. (ClinicalTrials.gov number, NCT00233324.)
Authors:
; Neil N Finer; Waldemar A Carlo; Michele C Walsh; Wade Rich; Marie G Gantz; Abbot R Laptook; Bradley A Yoder; Roger G Faix; Abhik Das; W Kenneth Poole; Edward F Donovan; Nancy S Newman; Namasivayam Ambalavanan; Ivan D Frantz; Susie Buchter; Pablo J Sánchez; Kathleen A Kennedy; Nirupama Laroia; Brenda B Poindexter; C Michael Cotten; Krisa P Van Meurs; Shahnaz Duara; Vivek Narendran; Beena G Sood; T Michael O'Shea; Edward F Bell; Vineet Bhandari; Kristi L Watterberg; Rosemary D Higgins
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2010-05-16
Journal Detail:
Title:  The New England journal of medicine     Volume:  362     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-05-27     Completed Date:  2010-06-03     Revised Date:  2014-03-19    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1970-9     Citation Subset:  AIM; IM    
Copyright Information:
2010 Massachusetts Medical Society
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00233324
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MeSH Terms
Descriptor/Qualifier:
Apgar Score
Bronchopulmonary Dysplasia / epidemiology*
Continuous Positive Airway Pressure*
Female
Hospital Mortality
Humans
Infant Mortality*
Infant, Extremely Low Birth Weight*
Infant, Newborn
Infant, Premature
Intention to Treat Analysis
Intubation, Intratracheal*
Male
Oximetry
Oxygen / administration & dosage,  blood
Oxygen Inhalation Therapy / methods*
Pulmonary Surfactants / therapeutic use*
Retinopathy of Prematurity / epidemiology
Grant Support
ID/Acronym/Agency:
M01 RR000030-45/RR/NCRR NIH HHS; M01 RR125/RR/NCRR NIH HHS; M01 RR16587/RR/NCRR NIH HHS; M01 RR30/RR/NCRR NIH HHS; M01 RR32/RR/NCRR NIH HHS; M01 RR39/RR/NCRR NIH HHS; M01 RR44/RR/NCRR NIH HHS; M01 RR54/RR/NCRR NIH HHS; M01 RR59/RR/NCRR NIH HHS; M01 RR6022/RR/NCRR NIH HHS; M01 RR633/RR/NCRR NIH HHS; M01 RR64/RR/NCRR NIH HHS; M01 RR70/RR/NCRR NIH HHS; M01 RR7122/RR/NCRR NIH HHS; M01 RR750/RR/NCRR NIH HHS; M01 RR80/RR/NCRR NIH HHS; M01 RR8084/RR/NCRR NIH HHS; M01 RR997/RR/NCRR NIH HHS; U10 HD021364-23/HD/NICHD NIH HHS; U10 HD021373-24/HD/NICHD NIH HHS; U10 HD021385-23/HD/NICHD NIH HHS; U10 HD027851-18/HD/NICHD NIH HHS; U10 HD027853/HD/NICHD NIH HHS; U10 HD027853-18/HD/NICHD NIH HHS; U10 HD027856-18/HD/NICHD NIH HHS; U10 HD027871-18/HD/NICHD NIH HHS; U10 HD027880-18/HD/NICHD NIH HHS; U10 HD027904-18/HD/NICHD NIH HHS; U10 HD034216-13/HD/NICHD NIH HHS; U10 HD036790-12/HD/NICHD NIH HHS; U10 HD040461-05/HD/NICHD NIH HHS; U10 HD040492/HD/NICHD NIH HHS; U10 HD040492-08/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 HD040689-08/HD/NICHD NIH HHS; U10 HD053089/HD/NICHD NIH HHS; U10 HD053089-04/HD/NICHD NIH HHS; U10 HD053109-04/HD/NICHD NIH HHS; U10 HD053119-04/HD/NICHD NIH HHS; U10 HD053124-03/HD/NICHD NIH HHS; U10 HD21364/HD/NICHD NIH HHS; U10 HD21373/HD/NICHD NIH HHS; U10 HD21385/HD/NICHD NIH HHS; U10 HD21397/HD/NICHD NIH HHS; U10 HD27851/HD/NICHD NIH HHS; U10 HD27853/HD/NICHD NIH HHS; U10 HD27856/HD/NICHD NIH HHS; U10 HD27871/HD/NICHD NIH HHS; U10 HD27880/HD/NICHD NIH HHS; U10 HD27904/HD/NICHD NIH HHS; U10 HD34216/HD/NICHD NIH HHS; U10 HD36790/HD/NICHD NIH HHS; U10 HD40461/HD/NICHD NIH HHS; U10 HD40492/HD/NICHD NIH HHS; U10 HD40498/HD/NICHD NIH HHS; U10 HD40521/HD/NICHD NIH HHS; U10 HD40689/HD/NICHD NIH HHS; U10 HD53089/HD/NICHD NIH HHS; U10 HD53109/HD/NICHD NIH HHS; U10 HD53119/HD/NICHD NIH HHS; U10 HD53124/HD/NICHD NIH HHS; UL1 RR24139/RR/NCRR NIH HHS; UL1 RR24979/RR/NCRR NIH HHS; UL1 RR25008/RR/NCRR NIH HHS; UL1 RR25744/RR/NCRR NIH HHS; UL1 TR000041/TR/NCATS NIH HHS
Chemical
Reg. No./Substance:
0/Pulmonary Surfactants; S88TT14065/Oxygen
Investigator
Investigator/Affiliation:
A H Jobe / ; M S Caplan / ; W Oh / ; A M Hensman / ; D Gingras / ; S Barnett / ; S Lillie / ; K Francis / ; D Andrews / ; K Angela / ; A A Fanaroff / ; B S Siner / ; K Schibler / ; K Bridges / ; B Alexander / ; C Grisby / ; M W Mersmann / ; H L Mincey / ; J Hessling / ; R N Goldberg / ; K J Auten / ; K A Fisher / ; K A Foy / ; G Siaw / ; B J Stoll / ; A Piazza / ; D P Carlton / ; E C Hale / ; S W Archer / ; J A Lemons / ; F Hamer / ; D E Herron / ; L C Miller / ; L D Wilson / ; M A Berberich / ; C J Blaisdell / ; D B Gail / ; J P Kiley / ; M Cunningham / ; B K Hastings / ; A R Irene / ; J O'Donnell Auman / ; C P Huitema / ; J W Pickett / ; D Wallace / ; K M Zaterka-Baxter / ; D K Stevenson / ; M B Ball / ; M S Proud / ; J M Fiascone / ; B L MacKinnon / ; E Nylen / ; A Furey / ; M V Collins / ; S S Cosby / ; V A Phillips / ; M R Rasmussen / ; P R Wozniak / ; K Arnell / ; R Bridge / ; C Demetrio / ; J A Widness / ; J M Klein / ; K J Johnson / ; R Everett-Thomas / ; R K Ohls / ; J Rohr / ; C B Lacy / ; D L Phelps / ; L J Reubens / ; E Burnell / ; C R Rosenfeld / ; W A Salhab / ; J Allen / ; A Guzman / ; G Hensley / ; M H Lepps / ; M Martin / ; N A Miller / ; A Solls / ; D M Vasil / ; K Wilder / ; B H Morris / ; J E Tyson / ; B F Harris / ; A E Lis / ; S Martin / ; G E McDavid / ; P L Tate / ; S L Wright / ; J Burnett / ; J J Jensen / ; K A Osborne / ; C Spencer / ; K Weaver-Lewis / ; N J Peters / ; S Shankaran / ; R Bara / ; E Billian / ; M Johnson / ; R A Ehrenkranz / ; H C Jacobs / ; P Cervone / ; P Gettner / ; M Konstantino / ; J Poulsen / ; J Taft / ; G Avery / ; C A Gleason / ; M C Allen / ; S I Bangdiwala / ; C J Blaisdell / ; D B Gail / ; C Hunt / ; R J Boyle / ; T Clemons / ; M E D'Alton / ; A Das / ; W K Poole / ; M Keszler / ; C K Redmond / ; M G Ross / ; M A Thomson / ; S J Weiner / ; M Willinger / ; G D Markowitz / ; A K Hutchinson / ; D K Wallace / ; S F Freedman /
Comments/Corrections
Comment In:
N Engl J Med. 2010 May 27;362(21):2024-6   [PMID:  20472938 ]
Erratum In:
N Engl J Med. 2010 Jun 10;362(23):2235

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


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