Target ranges of oxygen saturation in extremely preterm infants

Waldemar A. Carlo, Neil N. Finer, Michele C. Walsh, Wade Rich, Marie G. Gantz, Abbot R. Laptook, Bradley A. Yoder, Roger G. Faix, Abhik Das, W. Kenneth Poole, Kurt Schibler, Nancy S. Newman, Namasivayam Ambalavanan, Ivan D. Frantz, Anthony J. Piazza, Pablo J. Sánchez, Brenda H. Morris, Nirupama Laroia, Dale L. Phelps, Brenda B. PoindexterC. Michael Cotten, Krisa P. Van Meurs, Shahnaz Duara, Vivek Narendran, Beena G. Sood, T. Michael O'Shea, Edward F. Bell, Richard A. Ehrenkranz, Kristi L. Watterberg, Rosemary D. Higgins

Research output: Contribution to journalArticle

586 Citations (Scopus)

Abstract

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.)

Original languageEnglish
Pages (from-to)1959-1969
Number of pages11
JournalNew England Journal of Medicine
Volume362
Issue number21
DOIs
StatePublished - May 27 2010

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Extremely Premature Infants
Oxygen
Retinopathy of Prematurity
Confidence Intervals
Survivors
Continuous Positive Airway Pressure
Mortality
Intubation
Premature Infants
Surface-Active Agents
Pregnancy
Incidence

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Carlo, W. A., Finer, N. N., Walsh, M. C., Rich, W., Gantz, M. G., Laptook, A. R., ... Higgins, R. D. (2010). Target ranges of oxygen saturation in extremely preterm infants. New England Journal of Medicine, 362(21), 1959-1969. https://doi.org/10.1056/NEJMoa0911781

Target ranges of oxygen saturation in extremely preterm infants. / Carlo, Waldemar A.; Finer, Neil N.; Walsh, Michele C.; Rich, Wade; Gantz, Marie G.; Laptook, Abbot R.; Yoder, Bradley A.; Faix, Roger G.; Das, Abhik; Poole, W. Kenneth; Schibler, Kurt; Newman, Nancy S.; Ambalavanan, Namasivayam; Frantz, Ivan D.; Piazza, Anthony J.; Sánchez, Pablo J.; Morris, Brenda H.; Laroia, Nirupama; Phelps, Dale L.; Poindexter, Brenda B.; Cotten, C. Michael; Van Meurs, Krisa P.; Duara, Shahnaz; Narendran, Vivek; Sood, Beena G.; O'Shea, T. Michael; Bell, Edward F.; Ehrenkranz, Richard A.; Watterberg, Kristi L.; Higgins, Rosemary D.

In: New England Journal of Medicine, Vol. 362, No. 21, 27.05.2010, p. 1959-1969.

Research output: Contribution to journalArticle

Carlo, WA, Finer, NN, Walsh, MC, Rich, W, Gantz, MG, Laptook, AR, Yoder, BA, Faix, RG, Das, A, Poole, WK, Schibler, K, Newman, NS, Ambalavanan, N, Frantz, ID, Piazza, AJ, Sánchez, PJ, Morris, BH, Laroia, N, Phelps, DL, Poindexter, BB, Cotten, CM, Van Meurs, KP, Duara, S, Narendran, V, Sood, BG, O'Shea, TM, Bell, EF, Ehrenkranz, RA, Watterberg, KL & Higgins, RD 2010, 'Target ranges of oxygen saturation in extremely preterm infants', New England Journal of Medicine, vol. 362, no. 21, pp. 1959-1969. https://doi.org/10.1056/NEJMoa0911781
Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR et al. Target ranges of oxygen saturation in extremely preterm infants. New England Journal of Medicine. 2010 May 27;362(21):1959-1969. https://doi.org/10.1056/NEJMoa0911781
Carlo, Waldemar A. ; Finer, Neil N. ; Walsh, Michele C. ; Rich, Wade ; Gantz, Marie G. ; Laptook, Abbot R. ; Yoder, Bradley A. ; Faix, Roger G. ; Das, Abhik ; Poole, W. Kenneth ; Schibler, Kurt ; Newman, Nancy S. ; Ambalavanan, Namasivayam ; Frantz, Ivan D. ; Piazza, Anthony J. ; Sánchez, Pablo J. ; Morris, Brenda H. ; Laroia, Nirupama ; Phelps, Dale L. ; Poindexter, Brenda B. ; Cotten, C. Michael ; Van Meurs, Krisa P. ; Duara, Shahnaz ; Narendran, Vivek ; Sood, Beena G. ; O'Shea, T. Michael ; Bell, Edward F. ; Ehrenkranz, Richard A. ; Watterberg, Kristi L. ; Higgins, Rosemary D. / Target ranges of oxygen saturation in extremely preterm infants. In: New England Journal of Medicine. 2010 ; Vol. 362, No. 21. pp. 1959-1969.
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abstract = "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.)",
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T1 - Target ranges of oxygen saturation in extremely preterm infants

AU - Carlo, Waldemar A.

AU - Finer, Neil N.

AU - Walsh, Michele C.

AU - Rich, Wade

AU - Gantz, Marie G.

AU - Laptook, Abbot R.

AU - Yoder, Bradley A.

AU - Faix, Roger G.

AU - Das, Abhik

AU - Poole, W. Kenneth

AU - Schibler, Kurt

AU - Newman, Nancy S.

AU - Ambalavanan, Namasivayam

AU - Frantz, Ivan D.

AU - Piazza, Anthony J.

AU - Sánchez, Pablo J.

AU - Morris, Brenda H.

AU - Laroia, Nirupama

AU - Phelps, Dale L.

AU - Poindexter, Brenda B.

AU - Cotten, C. Michael

AU - Van Meurs, Krisa P.

AU - Duara, Shahnaz

AU - Narendran, Vivek

AU - Sood, Beena G.

AU - O'Shea, T. Michael

AU - Bell, Edward F.

AU - Ehrenkranz, Richard A.

AU - Watterberg, Kristi L.

AU - Higgins, Rosemary D.

PY - 2010/5/27

Y1 - 2010/5/27

N2 - 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.)

AB - 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.)

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