Document Detail


Target ranges of oxygen saturation in extremely preterm infants.
MedLine Citation:
PMID:  20472937     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Previous studies have suggested that the incidence of retinopathy is lower in preterm infants with exposure to reduced levels of oxygenation than in those exposed to higher levels of oxygenation. However, it is unclear what range of oxygen saturation is appropriate to minimize retinopathy without increasing adverse outcomes.
METHODS: We performed a randomized trial with a 2-by-2 factorial design to compare target ranges of oxygen saturation of 85 to 89% or 91 to 95% among 1316 infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. The primary outcome was a composite of severe retinopathy of prematurity (defined as the presence of threshold retinopathy, the need for surgical ophthalmologic intervention, or the use of bevacizumab), death before discharge from the hospital, or both. All infants were also randomly assigned to continuous positive airway pressure or intubation and surfactant.
RESULTS: The rates of severe retinopathy or death did not differ significantly between the lower-oxygen-saturation group and the higher-oxygen-saturation group (28.3% and 32.1%, respectively; relative risk with lower oxygen saturation, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P=0.21). Death before discharge occurred more frequently in the lower-oxygen-saturation group (in 19.9% of infants vs. 16.2%; relative risk, 1.27; 95% CI, 1.01 to 1.60; P=0.04), whereas severe retinopathy among survivors occurred less often in this group (8.6% vs. 17.9%; relative risk, 0.52; 95% CI, 0.37 to 0.73; P<0.001). There were no significant differences in the rates of other adverse events.
CONCLUSIONS: A lower target range of oxygenation (85 to 89%), as compared with a higher range (91 to 95%), did not significantly decrease the composite outcome of severe retinopathy or death, but it resulted in an increase in mortality and a substantial decrease in severe retinopathy among survivors. The increase in mortality is a major concern, since a lower target range of oxygen saturation is increasingly being advocated to prevent retinopathy of prematurity. (ClinicalTrials.gov number, NCT00233324.)
Authors:
; Waldemar A Carlo; Neil N Finer; Michele C Walsh; Wade Rich; Marie G Gantz; Abbot R Laptook; Bradley A Yoder; Roger G Faix; Abhik Das; W Kenneth Poole; Kurt Schibler; Nancy S Newman; Namasivayam Ambalavanan; Ivan D Frantz; Anthony J Piazza; Pablo J Sánchez; Brenda H Morris; Nirupama Laroia; Dale L Phelps; Brenda B Poindexter; C Michael Cotten; Krisa P Van Meurs; Shahnaz Duara; Vivek Narendran; Beena G Sood; T Michael O'Shea; Edward F Bell; Richard A Ehrenkranz; 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:  1959-69     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:
Continuous Positive Airway Pressure
Female
Hospital Mortality
Humans
Infant Mortality*
Infant, Newborn
Infant, Premature / blood*
Intubation, Intratracheal
Kaplan-Meier Estimate
Male
Oximetry
Oxygen / administration & dosage,  blood*
Oxygen Inhalation Therapy / adverse effects,  methods*
Proportional Hazards Models
Pulmonary Surfactants / therapeutic use
Reference Values
Retinopathy of Prematurity / epidemiology,  prevention & control*
Grant Support
ID/Acronym/Agency:
K23 HD041423/HD/NICHD NIH HHS; 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 / ; A Zadell / ; J DiFiore / ; E F Donovan / ; 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 / ; S Buchter / ; D P Carlton / ; E C Hale / ; A K Hutchinson / ; 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'D 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 / ; A Furey / ; B L MacKinnon / ; E Nylen / ; 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 / ; G D Markowitz / ; L J Reubens / ; E Burnell / ; C R Rosenfeld / ; W A Salhab / ; A Guzman / ; G Hensley / ; M H Lepps / ; N A Miller / ; J Allen / ; L Grau / ; M Martin / ; A Solis / ; D M Vasil / ; K Wilder / ; K A Kennedy / ; J E Tyson / ; B F Harris / ; A E Lis / ; S Martin / ; G 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 / ; V Bhandari / ; 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 / ; R J Boyle / ; T Clemons / ; M E D'Alton / ; A Das / ; D B Gail / ; C Hunt / ; M Keszler / ; W K Poole / ; 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 ]
N Engl J Med. 2013 May 30;368(22):2141-2   [PMID:  23642082 ]
N Engl J Med. 2010 Sep 23;363(13):1285; author reply 1285-6   [PMID:  20860514 ]

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


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