Neurodevelopmental Outcomes in the Early CPAP and Pulse Oximetry Trial

被引：146

作者：

Vaucher, Yvonne E.

Peralta-Carcelen, Myriam ^{[4
]}

Finer, Neil N. ^{[1
]}

Carlo, Waldemar A. ^{[4
]}

Gantz, Marie G. ^{[5
]}

Walsh, Michele C. ^{[8
]}

Laptook, Abbot R. ^{[11
]}

Yoder, Bradley A. ^{[12
]}

Faix, Roger G. ^{[12
]}

Das, Abhik ^{[13
]}

Schibler, Kurt ^{[9
,10
]}

Rich, Wade

Newman, Nancy S. ^{[8
]}

Vohr, Betty R. ^{[11
]}

Yolton, Kimberly ^{[9
,10
]}

Heyne, Roy J. ^{[15
]}

Wilson-Costello, Deanne E. ^{[8
]}

Evans, Patricia W. ^{[16
]}

Goldstein, Ricki F. ^{[6
]}

Acarregui, Michael J. ^{[17
]}

Adams-Chapman, Ira ^{[18
,19
]}

Pappas, Athina ^{[20
]}

Hintz, Susan R. ^{[2
,3
]}

Poindexter, Brenda ^{[21
]}

Dusick, Anna M. ^{[21
]}

McGowan, Elisabeth C. ^{[22
]}

Ehrenkranz, Richard A. ^{[23
]}

Bodnar, Anna ^{[12
]}

Bauer, Charles R. ^{[24
]}

Fuller, Janell ^{[25
]}

O'Shea, T. Michael ^{[7
]}

Myers, Gary J. ^{[26
]}

Higgins, Rosemary D. ^{[14
]}

机构：

[1] Univ Calif San Diego, Div Neonatol, Dept Pediat, San Diego, CA 92013 USA

[2] Stanford Univ, Sch Med, Dept Pediat, Div Neonatal & Dev Med, Palo Alto, CA 94304 USA

[3] Lucile Packard Childrens Hosp, Palo Alto, CA USA

[4] Univ Alabama Birmingham, Dept Pediat, Birmingham, AL USA

[5] RTI Int, Stat & Epidemiol Unit, Res Triangle Pk, NC USA

[6] Duke Univ, Dept Pediat, Durham, NC 27706 USA

[7] Wake Forest Univ, Bowman Gray Sch Med, Winston Salem, NC USA

[8] Case Western Reserve Univ, Rainbow Babies & Childrens Hosp, Dept Pediat, Cleveland, OH 44106 USA

[9] Cincinnati Childrens Hosp Med Ctr, Dept Pediat, Cincinnati, OH USA

[10] Univ Cincinnati, Cincinnati, OH 45221 USA

[11] Brown Univ, Women & Infants Hosp, Dept Pediat, Providence, RI 02908 USA

[12] Univ Utah, Sch Med, Dept Pediat, Div Neonatol, Salt Lake City, UT USA

[13] RTI Int, Stat & Epidemiol Unit, Rockville, MD USA

[14] Eunice Kennedy Shriver Natl Inst Child Hlth & Hum, NIH, Bethesda, MD USA

[15] Univ Texas SW Med Ctr Dallas, Dept Pediat, Dallas, TX 75390 USA

[16] Univ Texas Houston, Med Sch Houston, Houston, TX USA

[17] Univ Iowa, Dept Pediat, Iowa City, IA 52242 USA

[18] Emory Univ, Sch Med, Dept Pediat, Atlanta, GA USA

[19] Childrens Healthcare Atlanta, Atlanta, GA USA

[20] Wayne State Univ, Dept Pediat, Detroit, MI 48202 USA

[21] Indiana Univ Sch Med, Dept Pediat, Indianapolis, IN USA

[22] Floating Hosp Children, Tufts Med Ctr, Div Newborn Med, Dept Pediat, Boston, MA USA

[23] Yale Univ, Sch Med, Dept Pediat, New Haven, CT 06510 USA

[24] Univ Miami, Miller Sch Med, Miami, FL 33136 USA

[25] Univ New Mexico, Hlth Sci Ctr, Albuquerque, NM 87131 USA

[26] Univ Rochester, Med Ctr, Dept Pediat, Rochester, NY 14642 USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2012年 / 367卷 / 26期

关键词：

BIRTH-WEIGHT INFANTS; FREQUENCY OSCILLATORY VENTILATION; PRETERM INFANTS; CEREBRAL-PALSY; CONVENTIONAL VENTILATION; NEONATAL MORBIDITIES; OXYGEN-SATURATION; AGE; RETINOPATHY; PREMATURITY;

D O I：

10.1056/NEJMoa1208506

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.)

引用

页码：2495 / 2504

页数：10

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