Target Ranges of Oxygen Saturation in Extremely Preterm Infants.

被引：712

作者：

Carlo, Waldemar A. ^{[1
]}

Finer, Neil N. ^{[2
]}

Walsh, Michele C. ^{[3
]}

Rich, Wade ^{[2
]}

Gantz, Marie G. ^{[4
]}

Laptook, Abbot R. ^{[7
]}

Yoder, Bradley A. ^{[8
]}

Faix, Roger G. ^{[8
]}

Das, Abhik ^{[9
]}

Poole, W. Kenneth ^{[4
]}

Schibler, Kurt ^{[11
]}

Newman, Nancy S. ^{[3
]}

Ambalavanan, Namasivayam ^{[1
]}

Frantz, Ivan D., III ^{[12
]}

Piazza, Anthony J. ^{[14
,15
]}

Sanchez, Pablo J. ^{[13
]}

Morris, Brenda H. ^{[16
]}

Laroia, Nirupama ^{[17
]}

Phelps, Dale L. ^{[17
]}

Poindexter, Brenda B. ^{[18
]}

Cotten, C. Michael ^{[5
]}

Van Meurs, Krisa P. ^{[19
]}

Duara, Shahnaz ^{[20
]}

Narendran, Vivek ^{[11
]}

Sood, Beena G. ^{[21
]}

O'Shea, T. Michael ^{[6
]}

Bell, Edward F. ^{[22
]}

Ehrenkranz, Richard A. ^{[23
]}

Watterberg, Kristi L. ^{[24
]}

Higgins, Rosemary D. ^{[10
]}

Jobe, A. H.

Caplan, M. S. ^{[25
]}

Oh, W. ^{[26
]}

Hensman, A. M. ^{[26
]}

Gingras, D. ^{[26
]}

Barnett, S. ^{[26
]}

Lillie, S. ^{[26
]}

Francis, K. ^{[26
]}

Andrews, D. ^{[26
]}

Angela, K. ^{[26
]}

Fanaroff, A. A. ^{[27
,28
,29
]}

Siner, B. S. ^{[27
,28
,29
]}

Zadell, A. ^{[27
,28
,29
]}

DiFiore, J. ^{[27
,28
,29
]}

Donovan, E. F. ^{[30
,31
]}

Bridges, K. ^{[30
,31
]}

Alexander, B. ^{[30
,31
]}

Grisby, C. ^{[30
,31
]}

Mersmann, M. W. ^{[30
,31
]}

Mincey, H. L. ^{[30
,31
]}

机构：

[1] Univ Alabama Birmingham, Div Neonatol, Birmingham, AL 35294 USA

[2] Univ Calif San Diego, San Diego, CA 92103 USA

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

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

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

[6] Wake Forest Univ, Sch Med, Winston Salem, NC 27109 USA

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

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

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

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

[11] Univ Cincinnati, Dept Pediat, Cincinnati, OH 45221 USA

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

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

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

[15] Childrens Healthcare Atlanta, Atlanta, GA USA

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

[17] Univ Rochester, Sch Med & Dent, Rochester, NY USA

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

[19] Stanford Univ, Sch Med, Dept Pediat, Palo Alto, CA 94304 USA

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

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

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

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

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

[25] Univ Chicago, Pritzker Sch Med, Chicago, IL 60637 USA

[26] Rainbow Babies & Childrens Hosp, Cleveland, OH USA

[27] Univ Cincinnati Hosp, Cincinnati, OH USA

[28] Good Samaritan Hosp, Cincinnati, OH USA

[29] Cincinnati Childrens Hosp Med Ctr, Cincinnati, OH USA

[30] Duke Univ, Sch Med, Univ Hosp, Alamance Reg Med Ctr, Durham, NC USA

[31] Durham Reg Hosp, Durham, NC USA

[32] Childrens Healthcare Atlanta, Atlanta, GA USA

[33] Grady Mem Hosp, Atlanta, GA USA

[34] Emory Crawford Long Hosp, Atlanta, GA USA

[35] Indiana Univ Hosp, Indianapolis, IN 46202 USA

[36] Methodist Hosp, Indianapolis, IN USA

[37] Riley Hosp Children, Indianapolis, IN USA

[38] Wishard Hlth Serv, Indianapolis, IN USA

[39] NHLBI, Bethesda, MD 20892 USA

[40] Stanford Univ, Lucile Packard Childrens Hosp, Palo Alto, CA 94304 USA

[41] Floating Hosp Children, Tufts Med Ctr, Boston, MA USA

[42] Univ Alabama Birmingham Hlth Syst, Birmingham, AL USA

[43] Childrens Hosp Alabama, Birmingham, AL USA

[44] Univ Calif San Diego, Med Ctr, San Diego, CA 92103 USA

[45] Sharp Mary Birch Hosp Women, San Diego, CA USA

[46] Univ Iowa Childrens Hosp, Iowa City, IA USA

[47] Univ Miami, Holtz Childrens Hosp, Miami, FL USA

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

[49] Univ Rochester, Med Ctr, Golisano Childrens Hosp, Rochester, NY 14642 USA

[50] Univ Texas SW Med Ctr Dallas, Parkland Hlth & Hosp Syst, Dallas, TX 75390 USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2010年 / 362卷 / 21期

基金：

美国国家卫生研究院;

关键词：

BRONCHOPULMONARY DYSPLASIA; SEVERE RETINOPATHY; PATHOGENESIS; PREMATURITY; INJURY;

D O I：

10.1056/NEJMoa0911781

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: Previous studies have suggested that the incidence of retinopathy is lower in preterm infants with exposure to reduced levels of oxygenation than in those exposed to higher levels of oxygenation. However, it is unclear what range of oxygen saturation is appropriate to minimize retinopathy without increasing adverse outcomes. Methods: We performed a randomized trial with a 2-by-2 factorial design to compare target ranges of oxygen saturation of 85 to 89% or 91 to 95% among 1316 infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. The primary outcome was a composite of severe retinopathy of prematurity (defined as the presence of threshold retinopathy, the need for surgical ophthalmologic intervention, or the use of bevacizumab), death before discharge from the hospital, or both. All infants were also randomly assigned to continuous positive airway pressure or intubation and surfactant. Results: The rates of severe retinopathy or death did not differ significantly between the lower-oxygen-saturation group and the higher-oxygen-saturation group (28.3% and 32.1%, respectively; relative risk with lower oxygen saturation, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P=0.21). Death before discharge occurred more frequently in the lower-oxygen-saturation group (in 19.9% of infants vs. 16.2%; relative risk, 1.27; 95% CI, 1.01 to 1.60; P=0.04), whereas severe retinopathy among survivors occurred less often in this group (8.6% vs. 17.9%; relative risk, 0.52; 95% CI, 0.37 to 0.73; P<0.001). There were no significant differences in the rates of other adverse events. Conclusions: A lower target range of oxygenation (85 to 89%), as compared with a higher range (91 to 95%), did not significantly decrease the composite outcome of severe retinopathy or death, but it resulted in an increase in mortality and a substantial decrease in severe retinopathy among survivors. The increase in mortality is a major concern, since a lower target range of oxygen saturation is increasingly being advocated to prevent retinopathy of prematurity. (ClinicalTrials.gov number, NCT00233324.) N Engl J Med 2010;362:1959-69.

引用

页码：1959 / 1969

页数：11

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