title: Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial.
abstract: 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.affiliation: Department of Pediatrics, University of California at San Diego, San Diego, California 92013, USA.
authors.forename: Yvonne E
authors.initials: YE
authors.lastname: Vaucher
authors.forename: Myriam
authors.initials: M
authors.lastname: Peralta-Carcelen
authors.forename: Neil N
authors.initials: NN
authors.lastname: Finer
authors.forename: Waldemar A
authors.initials: WA
authors.lastname: Carlo
authors.forename: Marie G
authors.initials: MG
authors.lastname: Gantz
authors.forename: Michele C
authors.initials: MC
authors.lastname: Walsh
authors.forename: Abbot R
authors.initials: AR
authors.lastname: Laptook
authors.forename: Bradley A
authors.initials: BA
authors.lastname: Yoder
authors.forename: Roger G
authors.initials: RG
authors.lastname: Faix
authors.forename: Abhik
authors.initials: A
authors.lastname: Das
authors.forename: Kurt
authors.initials: K
authors.lastname: Schibler
authors.forename: Wade
authors.initials: W
authors.lastname: Rich
authors.forename: Nancy S
authors.initials: NS
authors.lastname: Newman
authors.forename: Betty R
authors.initials: BR
authors.lastname: Vohr
authors.forename: Kimberly
authors.initials: K
authors.lastname: Yolton
authors.forename: Roy J
authors.initials: RJ
authors.lastname: Heyne
authors.forename: Deanne E
authors.initials: DE
authors.lastname: Wilson-Costello
authors.forename: Patricia W
authors.initials: PW
authors.lastname: Evans
authors.forename: Ricki F
authors.initials: RF
authors.lastname: Goldstein
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Acarregui
authors.forename: Ira
authors.initials: I
authors.lastname: Adams-Chapman
authors.forename: Athina
authors.initials: A
authors.lastname: Pappas
authors.forename: Susan R
authors.initials: SR
authors.lastname: Hintz
authors.forename: Brenda
authors.initials: B
authors.lastname: Poindexter
authors.forename: Anna M
authors.initials: AM
authors.lastname: Dusick
authors.forename: Elisabeth C
authors.initials: EC
authors.lastname: McGowan
authors.forename: Richard A
authors.initials: RA
authors.lastname: Ehrenkranz
authors.forename: Anna
authors.initials: A
authors.lastname: Bodnar
authors.forename: Charles R
authors.initials: CR
authors.lastname: Bauer
authors.forename: Janell
authors.initials: J
authors.lastname: Fuller
authors.forename: T Michael
authors.initials: TM
authors.lastname: O'Shea
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Myers
authors.forename: Rosemary D
authors.initials: RD
authors.lastname: Higgins
mesh_terms: D001997:Bronchopulmonary Dysplasia / Q000453:epidemiology; D002657:Child Development; D045422:Continuous Positive Airway Pressure / Q000009:adverse effects; D002658:Developmental Disabilities / Q000453:epidemiology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D052577:Infant, Extremely Low Birth Weight; D062071:Infant, Extremely Premature; D007231:Infant, Newborn; D017063:Outcome Assessment, Health Care; D010092:Oximetry; D010100:Oxygen / Q000008:administration & dosage / Q000097:blood; D010102:Oxygen Inhalation Therapy / Q000009:adverse effects; D011663:Pulmonary Surfactants / Q000009:adverse effects / Q000627:therapeutic use*; D012178:Retinopathy of Prematurity / Q000453:epidemiology; D012959:Socioeconomic Factors
chemical_list: D011663:Pulmonary Surfactants; D010100:Oxygen