Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial

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 & 13 others 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

Research output: Contribution to journalArticle

114 Citations (Scopus)

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.)

Original languageEnglish (US)
Pages (from-to)2495-2504
Number of pages10
JournalNew England Journal of Medicine
Volume367
Issue number26
DOIs
StatePublished - Dec 27 2012

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Continuous Positive Airway Pressure
Oximetry
Oxygen
Surface-Active Agents
Confidence Intervals
National Institute of Child Health and Human Development (U.S.)
Extremely Premature Infants
National Heart, Lung, and Blood Institute (U.S.)
Bronchopulmonary Dysplasia
Mortality
Ventilation
Pregnancy
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Vaucher, Y. E., Peralta-Carcelen, M., Finer, N. N., Carlo, W. A., Gantz, M. G., Walsh, M. C., ... Higgins, R. D. (2012). Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial. New England Journal of Medicine, 367(26), 2495-2504. https://doi.org/10.1056/NEJMoa1208506

Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial. / Vaucher, Yvonne E.; Peralta-Carcelen, Myriam; Finer, Neil N.; Carlo, Waldemar A.; Gantz, Marie G.; Walsh, Michele C.; Laptook, Abbot R.; Yoder, Bradley A.; Faix, Roger G.; Das, Abhik; Schibler, Kurt; Rich, Wade; Newman, Nancy S.; Vohr, Betty R.; Yolton, Kimberly; Heyne, Roy J.; Wilson-Costello, Deanne E.; Evans, Patricia W.; Goldstein, Ricki F.; Acarregui, Michael J.; Adams-Chapman, Ira; Pappas, Athina; Hintz, Susan R.; Poindexter, Brenda; Dusick, Anna M.; McGowan, Elisabeth C.; Ehrenkranz, Richard A.; Bodnar, Anna; Bauer, Charles R.; Fuller, Janell; O'Shea, T. Michael; Myers, Gary J.; Higgins, Rosemary D.

In: New England Journal of Medicine, Vol. 367, No. 26, 27.12.2012, p. 2495-2504.

Research output: Contribution to journalArticle

Vaucher, YE, Peralta-Carcelen, M, Finer, NN, Carlo, WA, Gantz, MG, Walsh, MC, Laptook, AR, Yoder, BA, Faix, RG, Das, A, Schibler, K, Rich, W, Newman, NS, Vohr, BR, Yolton, K, Heyne, RJ, Wilson-Costello, DE, Evans, PW, Goldstein, RF, Acarregui, MJ, Adams-Chapman, I, Pappas, A, Hintz, SR, Poindexter, B, Dusick, AM, McGowan, EC, Ehrenkranz, RA, Bodnar, A, Bauer, CR, Fuller, J, O'Shea, TM, Myers, GJ & Higgins, RD 2012, 'Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial', New England Journal of Medicine, vol. 367, no. 26, pp. 2495-2504. https://doi.org/10.1056/NEJMoa1208506
Vaucher YE, Peralta-Carcelen M, Finer NN, Carlo WA, Gantz MG, Walsh MC et al. Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial. New England Journal of Medicine. 2012 Dec 27;367(26):2495-2504. https://doi.org/10.1056/NEJMoa1208506
Vaucher, Yvonne E. ; Peralta-Carcelen, Myriam ; Finer, Neil N. ; Carlo, Waldemar A. ; Gantz, Marie G. ; Walsh, Michele C. ; Laptook, Abbot R. ; Yoder, Bradley A. ; Faix, Roger G. ; Das, Abhik ; Schibler, Kurt ; Rich, Wade ; Newman, Nancy S. ; Vohr, Betty R. ; Yolton, Kimberly ; Heyne, Roy J. ; Wilson-Costello, Deanne E. ; Evans, Patricia W. ; Goldstein, Ricki F. ; Acarregui, Michael J. ; Adams-Chapman, Ira ; Pappas, Athina ; Hintz, Susan R. ; Poindexter, Brenda ; Dusick, Anna M. ; McGowan, Elisabeth C. ; Ehrenkranz, Richard A. ; Bodnar, Anna ; Bauer, Charles R. ; Fuller, Janell ; O'Shea, T. Michael ; Myers, Gary J. ; Higgins, Rosemary D. / Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial. In: New England Journal of Medicine. 2012 ; Vol. 367, No. 26. pp. 2495-2504.
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T1 - Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial

AU - Vaucher, Yvonne E.

AU - Peralta-Carcelen, Myriam

AU - Finer, Neil N.

AU - Carlo, Waldemar A.

AU - Gantz, Marie G.

AU - Walsh, Michele C.

AU - Laptook, Abbot R.

AU - Yoder, Bradley A.

AU - Faix, Roger G.

AU - Das, Abhik

AU - Schibler, Kurt

AU - Rich, Wade

AU - Newman, Nancy S.

AU - Vohr, Betty R.

AU - Yolton, Kimberly

AU - Heyne, Roy J.

AU - Wilson-Costello, Deanne E.

AU - Evans, Patricia W.

AU - Goldstein, Ricki F.

AU - Acarregui, Michael J.

AU - Adams-Chapman, Ira

AU - Pappas, Athina

AU - Hintz, Susan R.

AU - Poindexter, Brenda

AU - Dusick, Anna M.

AU - McGowan, Elisabeth C.

AU - Ehrenkranz, Richard A.

AU - Bodnar, Anna

AU - Bauer, Charles R.

AU - Fuller, Janell

AU - O'Shea, T. Michael

AU - Myers, Gary J.

AU - Higgins, Rosemary D.

PY - 2012/12/27

Y1 - 2012/12/27

N2 - 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.)

AB - 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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