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evident
Original paper
2010NEJMPediatrics

SUPPORT

Target ranges of oxygen saturation in extremely preterm infants

RCTNeonatology

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Overview

In extremely preterm infants, the lower saturation target did not change the composite of severe retinopathy or death; death was higher and retinopathy among survivors lower.

Clinical takeaway

The primary composite of severe retinopathy or death did not differ between 85-89% and 91-95% saturation targets. Death before discharge was higher and severe retinopathy among survivors was lower with the lower target. A lower target is not a net benefit.

Key result

Severe retinopathy or death: 28.3% vs 32.1% (RR 0.90, 95% CI 0.76-1.06; P=0.21). Death: 19.9% vs 16.2% (RR 1.27, 95% CI 1.01-1.60; P=0.04).

Practice impact

Do not lower saturation targets to 85-89% to prevent retinopathy; death was higher, and the primary composite did not improve.

Evidence

Study design

Randomized trial with a 2-by-2 factorial design comparing oxygen-saturation targets of 85 to 89% versus 91 to 95%, with a second randomization to continuous positive airway pressure or intubation and surfactant.

Enrollment

1,316

Follow-up

Until hospital discharge.

Geography

Not listed

Clinical question

Does a lower oxygen-saturation target (85 to 89%) reduce severe retinopathy or death compared with a higher target (91 to 95%) in extremely preterm infants?

Population

  • 1316 infants born between 24 weeks 0 days and 27 weeks 6 days of gestation.

Intervention

Target oxygen saturation 85 to 89%.

Comparator

Target oxygen saturation 91 to 95%.

Primary outcome

Composite of severe retinopathy of prematurity (threshold retinopathy, need for surgical ophthalmologic intervention, or use of bevacizumab), death before discharge from the hospital, or both.

The primary composite did not differ (28.3% vs 32.1%; RR 0.90, 95% CI 0.76-1.06; P=0.21). Death before discharge was higher with lower saturation (19.9% vs 16.2%; RR 1.27, 95% CI 1.01-1.60; P=0.04). Severe retinopathy among survivors was lower (8.6% vs 17.9%; RR 0.52, 95% CI 0.37-0.73; P<0.001).

Relative risk (lower vs higher saturation) / 0.9 / 95% CI 0.76-1.06 / p=0.21

Key results

  • The primary composite of severe retinopathy or death did not differ (28.3% with lower saturation vs 32.1% with higher saturation; RR 0.90, 95% CI 0.76-1.06; P=0.21).
  • Death before discharge was higher in the lower-saturation group (19.9% vs 16.2%; RR 1.27, 95% CI 1.01-1.60; P=0.04).
  • Severe retinopathy among survivors was lower in the lower-saturation group (8.6% vs 17.9%; RR 0.52, 95% CI 0.37-0.73; P<0.001).
  • There were no significant differences in the rates of other adverse events.

Harms

  • Death before discharge was higher with the lower saturation target (19.9% vs 16.2%; RR 1.27, 95% CI 1.01-1.60; P=0.04).
  • There were no significant differences in the rates of other adverse events.

Clinical Use

Practice impact

  • Do not adopt 85-89% saturation targets to prevent retinopathy of prematurity; the primary composite did not improve and mortality increased.

Applicability

  • Most applicable to extremely preterm infants born between 24 weeks 0 days and 27 weeks 6 days of gestation, followed through hospital discharge.

Limitations

  • This report is the oxygen-saturation factorial comparison; all infants were also assigned to CPAP or intubation and surfactant.
  • Severe retinopathy was reported among survivors, so that comparison is not a randomized ITT contrast of the original enrollment.
  • The abstract does not give the analyzed N for each percentage.

Common misinterpretations

  • Do not cite lower retinopathy among survivors as a reason to choose the lower target; death was higher, and the primary composite did not differ.
  • A lower saturation target is not a benefit in SUPPORT; the authors called the mortality increase a major concern.

Related evidence

Caffeine for Apnea of Prematurity - Earlier Trial

Citation

SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network, Carlo WA, Finer NN, et al. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010;362(21):1959-1969. doi:10.1056/NEJMoa0911781

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.