Document Detail


Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial.
MedLine Citation:
PMID:  23268664     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Previous results from our trial of early treatment with continuous positive airway pressure (CPAP) versus early surfactant treatment in infants showed no significant difference in the outcome of death or bronchopulmonary dysplasia. A lower (vs. higher) target range of oxygen saturation was associated with a lower rate of severe retinopathy but higher mortality. We now report longer-term results from our prespecified hypotheses.
METHODS: Using a 2-by-2 factorial design, we randomly assigned infants born between 24 weeks 0 days and 27 weeks 6 days of gestation to early CPAP with a limited ventilation strategy or early surfactant administration and to lower or higher target ranges of oxygen saturation (85 to 89% or 91 to 95%). The primary composite outcome for the longer-term analysis was death before assessment at 18 to 22 months or neurodevelopmental impairment at 18 to 22 months of corrected age.
RESULTS: The primary outcome was determined for 1234 of 1316 enrolled infants (93.8%); 990 of the 1058 surviving infants (93.6%) were evaluated at 18 to 22 months of corrected age. Death or neurodevelopmental impairment occurred in 27.9% of the infants in the CPAP group (173 of 621 infants), versus 29.9% of those in the surfactant group (183 of 613) (relative risk, 0.93; 95% confidence interval [CI], 0.78 to 1.10; P=0.38), and in 30.2% of the infants in the lower-oxygen-saturation group (185 of 612), versus 27.5% of those in the higher-oxygen-saturation group (171 of 622) (relative risk, 1.12; 95% CI, 0.94 to 1.32; P=0.21). Mortality was increased with the lower-oxygen-saturation target (22.1%, vs. 18.2% with the higher-oxygen-saturation target; relative risk, 1.25; 95% CI, 1.00 to 1.55; P=0.046).
CONCLUSIONS: We found no significant differences in the composite outcome of death or neurodevelopmental impairment among extremely premature infants randomly assigned to early CPAP or early surfactant administration and to a lower or higher target range of oxygen saturation. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Heart, Lung, and Blood Institute; SUPPORT ClinicalTrials.gov number, NCT00233324.).
Authors:
Yvonne E Vaucher; Myriam Peralta-Carcelen; Neil N Finer; Waldemar A Carlo; Marie G Gantz; Michele C Walsh; Abbot R Laptook; Bradley A Yoder; Roger G Faix; Abhik Das; Kurt Schibler; Wade Rich; Nancy S Newman; Betty R Vohr; Kimberly Yolton; Roy J Heyne; Deanne E Wilson-Costello; Patricia W Evans; Ricki F Goldstein; Michael J Acarregui; Ira Adams-Chapman; Athina Pappas; Susan R Hintz; Brenda Poindexter; Anna M Dusick; Elisabeth C McGowan; Richard A Ehrenkranz; Anna Bodnar; Charles R Bauer; Janell Fuller; T Michael O'Shea; Gary J Myers; 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    
Journal Detail:
Title:  The New England journal of medicine     Volume:  367     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-27     Completed Date:  2013-01-07     Revised Date:  2014-02-18    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2495-504     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00233324
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MeSH Terms
Descriptor/Qualifier:
Bronchopulmonary Dysplasia / epidemiology
Child Development*
Continuous Positive Airway Pressure* / adverse effects
Developmental Disabilities / epidemiology*
Female
Follow-Up Studies
Humans
Infant
Infant Mortality
Infant, Extremely Low Birth Weight
Infant, Extremely Premature
Infant, Newborn
Outcome Assessment (Health Care)
Oximetry
Oxygen / administration & dosage,  blood
Oxygen Inhalation Therapy* / adverse effects
Pulmonary Surfactants / adverse effects,  therapeutic use*
Retinopathy of Prematurity / epidemiology
Socioeconomic Factors
Grant Support
ID/Acronym/Agency:
U10 HD053089/HD/NICHD NIH HHS; UL1 TR000041/TR/NCATS NIH HHS
Chemical
Reg. No./Substance:
0/Pulmonary Surfactants; S88TT14065/Oxygen
Investigator
Investigator/Affiliation:
Abhik Das / ; Marie Gantz / ; Alan H Jobe / ; Michael S Caplan / ; William Oh / ; Angelita M Hensman / ; Bonnie E Stephens / ; Barbara Alksninis / ; Dawn Andrews / ; Kristen Angela / ; Susan Barnett / ; Bill Cashore / ; Melinda Caskey / ; Kim Francis / ; Dan Gingras / ; Regina A Gargus / ; Katharine Johnson / ; Shabnam Lainwala / ; Theresa M Leach / ; Martha R Leonard / ; Sarah Lillie / ; Kalida Mehta / ; James R Moore / ; Lucy Noel / ; Suzy Ventura / ; Rachel V Walden / ; Victoria E Watson / ; Avroy A Fanaroff / ; Bonnie S Siner / ; Arlene Zadell / ; Julie DiFiore / ; Monika Bhola / ; Harriet G Friedman / ; Gulgun Yalcinkaya / ; Edward F Donovan / ; Vivek Narendran / ; Kate Bridges / ; Barbara Alexander / ; Cathy Grisby / ; Marcia Worley Mersmann / ; Holly L Mincey / ; Jody Hessling / ; Teresa L Gratton / ; Ronald N Goldberg / ; C Michael Cotten / ; Patricia Ashley / ; Kathy J Auten / ; Kimberley A Fisher / ; Katherine A Foy / ; Sharon F Freedman / ; Kathryn E Gustafson / ; Melody B Lohmeyer / ; William F Malcolm / ; David K Wallace / ; Barbara J Stoll / ; Susie Buchter / ; Anthony J Piazza / ; David P Carlton / ; Linda Black / ; Ann M Blackwelder / ; Sheena Carter / ; Elisabeth Dinkins / ; Sobha Fritz / ; Ellen C Hale / ; Amy K Hutchinson / ; Maureen Mulligan LaRossa / ; Gloria V Smikle / ; Stephanie Wilson Archer / ; James A Lemons / ; Leslie D Wilson / ; Faithe Hamer / ; Ann B Cook / ; Dianne E Herron / ; Carolyn Lytle / ; Heike M Minnich / ; Mary Anne Berberich / ; Carol J Blaisdell / ; Dorothy B Gail / ; James P Kiley / ; W Kenneth Poole / ; Jamie E Newman / ; Betty K Hastings / ; Jeanette O'Donnell Auman / ; Carolyn Petrie Huitema / ; James W Pickett / ; Dennis Wallace / ; Kristin M Zaterka-Baxter / ; Krisa P Van Meurs / ; David K Stevenson / ; M Bethany Ball / ; Barbara Bentley / ; Elizabeth F Bruno / ; Alexis S Davis / ; Maria Elena DeAnda / ; Anne M DeBattista / ; Jean G Kohn / ; Melinda S Proud / ; Renee P Pyle / ; Nicholas H St John / ; Hali E Weiss / ; Ivan D Frantz / ; John M Fiascone / ; Anne Furey / ; Brenda L MacKinnon / ; Ellen Nylen / ; Ana Brussa / ; Cecelia Sibley / ; Namasivayam Ambalavanan / ; Monica V Collins / ; Shirley S Cosby / ; Vivien A Phillips / ; Kirstin J Bailey / ; Fred J Biasini / ; Maria Hopkins / ; Kristen C Johnston / ; Sara Krzywanski / ; Kathleen G Nelson / ; Cryshelle S Patterson / ; Richard V Rector / ; Leslie Rodriguez / ; Amanda Soong / ; Sally Whitley / ; Sheree York / ; Maynard R Rasmussen / ; Paul R Wozniak / ; Kathy Arnell / ; Rene Renee Bridge / ; Clarence Demetrio / ; Martha G Fuller / ; Edward F Bell / ; John A Widness / ; Jonathan M Klein / ; Tarah T Colaizy / ; Karen J Johnson / ; Diane L Eastman / ; Shahnaz Duara / ; Ruth Everett-Thomas / ; Maria Calejo / ; Alexis N Diaz / ; Silvia M Frade Eguaras / ; Andrea Garcia / ; Kasey Hamlin-Smith / ; Michelle Harwood Berkowits / ; Sylvia Hiriart-Fajardo / ; Elaine O Mathews / ; Helina Pierre / ; Arielle Riguard / ; Alexandra Stroerger / ; Kristi L Watterberg / ; Robin K Ohls / ; Julie Rohr / ; Conra Backstrom Lacy / ; Jean Lowe / ; Rebecca Montman / ; Nirupama Laroia / ; Dale L Phelps / ; Gary David Markowitz / ; Linda J Reubens / ; Diane Hust / ; Lisa Augostino / ; Julie Babish Johnson / ; Erica Burnell / ; Harris Gelbard / ; Rosemary L Jensen / ; Emily Kushner / ; Joan Merzbach / ; Jonathan Mink / ; Carlos Torres / ; David Wang / ; Kelley Yost / ; Pablo J Sánchez / ; Charles R Rosenfeld / ; Walid A Salhab / ; Sally S Adams / ; James Allen / ; Laura Grau / ; Alicia Guzman / ; Gaynelle Hensley / ; Elizabeth T Heyne / ; Melissa H Lepps / ; Linda A Madden / ; Melissa Martin / ; Nancy A Miller / ; Janet S Morgan / ; Araceli Solis / ; Lizette E Torres / ; Catherine Twell Boatman / ; Diana M Vasil / ; Kerry Wilder / ; Kathleen A Kennedy / ; Jon E Tyson / ; Nora I Alaniz / ; Patricia Evans / ; Beverly Foley Harris / ; Charles Green / ; Margarita Jiminez / ; Anna E Lis / ; Sarah Martin / ; Georgia E McDavid / ; Brenda H Morris / ; Margaret L Poundstone / ; Stacy Reddoch / ; Saba Siddiki / ; Patti L Pierce Tate / ; Laura L Whitely / ; Sharon L Wright / ; Shawna Baker / ; Karie Bird / ; Jill Burnett / ; Laura Cole / ; Karen A Osborne / ; Cynthia Spencer / ; Mike Steffens / ; Kimberlee Weaver-Lewis / ; Karen Zanetti / ; Robert G Dillard / ; Lisa K Washburn / ; Nancy J Peters / ; Barbara G Jackson / ; Korinne Chiu / ; Deborah Evans Allred / ; Donald J Goldstein / ; Raquel Halfond / ; Carroll Peterson / ; Ellen L Waldrep / ; Cherrie D Welch / ; Melissa Whalen Morris / ; Gail Wiley Hounshell / ; Seetha Shankaran / ; Beena G Sood / ; Rebecca Bara / ; Elizabeth Billian / ; Laura A Goldston / ; Mary Johnson / ; Vineet Bhandari / ; Harris C Jacobs / ; Pat Cervone / ; Patricia Gettner / ; Monica Konstantino / ; JoAnn Poulsen / ; Janet Taft / ; Christine G Butler / ; Nancy Close / ; Walter Gilliam / ; Sheila Greisman / ; Elaine Romano / ; Joanne Williams / ; Gordon Avery / ; Christine A Gleason / ; Marilee C Allen / ; Shrikant I Bangdiwala / ; Carol J Blaisdell / ; Robert J Boyle / ; Traci Clemons / ; Mary E D'Alton / ; Abhik Das / ; Dorothy B Gail / ; Carl Hunt / ; Martin Keszler / ; W Kenneth Poole / ; Carol K Redmond / ; Michael G Ross / ; Merran A Thomson / ; Steven J Weiner / ; Marian Willinger / ; Gary David Markowitz / ; Amy K Hutchinson / ; David K Wallace / ; Sharon F Freedman /
Comments/Corrections
Comment In:
Natl Med J India. 2013 May-Jun;26(3):163-5   [PMID:  24476165 ]
Z Geburtshilfe Neonatol. 2013 Feb;217(1):5-6   [PMID:  23556203 ]

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