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N Engl J Med. 2012 Dec 27;367(26):2495-504. doi: 10.1056/NEJMoa1208506.

Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial.

Collaborators (269)

Das A, Gantz M, Jobe AH, Caplan MS, Oh W, Hensman AM, Stephens BE, Alksninis B, Andrews D, Angela K, Barnett S, Cashore B, Caskey M, Francis K, Gingras D, Gargus RA, Johnson K, Lainwala S, Leach TM, Leonard MR, Lillie S, Mehta K, Moore JR, Noel L, Ventura S, Walden RV, Watson VE, Fanaroff AA, Siner BS, Zadell A, DiFiore J, Bhola M, Friedman HG, Yalcinkaya G, Donovan EF, Narendran V, Bridges K, Alexander B, Grisby C, Mersmann MW, Mincey HL, Hessling J, Gratton TL, Goldberg RN, Cotten C, Ashley P, Auten KJ, Fisher KA, Foy KA, Freedman SF, Gustafson KE, Lohmeyer MB, Malcolm WF, Wallace DK, Stoll BJ, Buchter S, Piazza AJ, Carlton DP, Black L, Blackwelder AM, Carter S, Dinkins E, Fritz S, Hale EC, Hutchinson AK, LaRossa MM, Smikle GV, Archer SW, Lemons JA, Wilson LD, Hamer F, Cook AB, Herron DE, Lytle C, Minnich HM, Berberich MA, Blaisdell CJ, Gail DB, Kiley JP, Poole W, Newman JE, Hastings BK, O'Donnell Auman J, Petrie Huitema C, Pickett JW 2nd, Wallace D, Zaterka-Baxter KM, Van Meurs KP, Stevenson DK, Ball M, Bentley B, Bruno EF, Davis AS, DeAnda ME, DeBattista AM, Kohn JG, Proud MS, Pyle RP, St John NH, Weiss HE, Frantz ID 3rd, Fiascone JM, Furey A, MacKinnon BL, Nylen E, Brussa A, Sibley C, Ambalavanan N, Collins MV, Cosby SS, Phillips VA, Bailey KJ, Biasini FJ, Hopkins M, Johnston KC, Krzywanski S, Nelson KG, Patterson CS, Rector RV, Rodriguez L, Soong A, Whitley S, York S, Rasmussen MR, Wozniak PR, Arnell K, Bridge RR, Demetrio C, Fuller MG, Bell EF, Widness JA, Klein JM, Colaizy TT, Johnson KJ, Eastman DL, Duara S, Everett-Thomas R, Calejo M, Diaz AN, Eguaras SM, Garcia A, Hamlin-Smith K, Harwood Berkowits M, Hiriart-Fajardo S, Mathews EO, Pierre H, Riguard A, Stroerger A, Watterberg KL, Ohls RK, Rohr J, Lacy CB, Lowe J, Montman R, Laroia N, Phelps DL, Markowitz GD, Reubens LJ, Hust D, Augostino L, Babish Johnson J, Burnell E, Gelbard H, Jensen RL, Kushner E, Merzbach J, Mink J, Torres C, Wang D, Yost K, Sánchez PJ, Rosenfeld CR, Salhab WA, Adams SS, Allen J, Grau L, Guzman A, Hensley G, Heyne ET, Lepps MH, Madden LA, Martin M, Miller NA, Morgan JS, Solis A, Torres LE, Twell Boatman C, Vasil DM, Wilder K, Kennedy KA, Tyson JE, Alaniz NI, Evans P, Foley Harris B, Green C, Jiminez M, Lis AE, Martin S, McDavid GE, Morris BH, Poundstone ML, Reddoch S, Siddiki S, Tate PL, Whitely LL, Wright SL, Baker S, Bird K, Burnett J, Cole L, Osborne KA, Spencer C, Steffens M, Weaver-Lewis K, Zanetti K, Dillard RG, Washburn LK, Peters NJ, Jackson BG, Chiu K, Evans Allred D, Goldstein DJ, Halfond R, Peterson C, Waldrep EL, Welch CD, Whalen Morris M, Wiley Hounshell G, Shankaran S, Sood BG, Bara R, Billian E, Goldston LA, Johnson M, Bhandari V, Jacobs HC, Cervone P, Gettner P, Konstantino M, Poulsen J, Taft J, Butler CG, Close N, Gilliam W, Greisman S, Romano E, Williams J, Avery G, Gleason CA, Allen MC, Bangdiwala SI, Blaisdell CJ, Boyle RJ, Clemons T, D'Alton ME, Das A, Gail DB, Hunt C, Keszler M, Poole W, Redmond CK, Ross MG, Thomson MA, Weiner SJ, Willinger M, Markowitz GD, Hutchinson AK, Wallace DK, Freedman SF.

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.).

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