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JAMA. 2018 Jun 5;319(21):2190-2201. doi: 10.1001/jama.2018.5725.

Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration.

Author information

1
National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.
2
Department of Paediatrics, University of Otago, Christchurch, New Zealand.
3
Department of Pediatrics, University of California, San Diego.
4
Division of Neonatology, University of Pennsylvania, Philadelphia.
5
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
6
Department of Neonatology, Royal Infirmary of Edinburgh, Edinburgh, Scotland.
7
Newborn Research, Royal Women's Hospital, Departments of Obstetrics and Gynaecology, and Paediatrics, University of Melbourne, Melbourne, Australia.
8
Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Australia.
9
Department of Pediatrics, University of Alabama, Birmingham.
10
Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, England.
11
National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, England.
12
Statistics and Epidemiology Unit, RTI International, Rockville, Maryland.
13
Statistics and Epidemiology Unit, RTI International, Research Triangle Park, North Carolina.
14
Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.
15
Department of Neonatology, Tuebingen University Hospital, Tuebingen, Germany.
16
Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada.
17
Newborn Services, Auckland City Hospital, Auckland, New Zealand.
18
Royal Maternity Hospital, Belfast, Ireland.
19
Department of Child Health, Queen's University, Belfast, Ireland.
20
EGA Institute for Women's Health, University College London, London, England.
21
Department of Neonatal Medicine, James Cook University, Middlesbrough, England.
22
University of Cambridge, Department of Obstetrics and Gynaecology, Cambridge, England.

Abstract

Importance:

There are potential benefits and harms of hyperoxemia and hypoxemia for extremely preterm infants receiving more vs less supplemental oxygen.

Objective:

To compare the effects of different target ranges for oxygen saturation as measured by pulse oximetry (Spo2) on death or major morbidity.

Design, Setting, and Participants:

Prospectively planned meta-analysis of individual participant data from 5 randomized clinical trials (conducted from 2005-2014) enrolling infants born before 28 weeks' gestation.

Exposures:

Spo2 target range that was lower (85%-89%) vs higher (91%-95%).

Main Outcomes and Measures:

The primary outcome was a composite of death or major disability (bilateral blindness, deafness, cerebral palsy diagnosed as ≥2 level on the Gross Motor Function Classification System, or Bayley-III cognitive or language score <85) at a corrected age of 18 to 24 months. There were 16 secondary outcomes including the components of the primary outcome and other major morbidities.

Results:

A total of 4965 infants were randomized (2480 to the lower Spo2 target range and 2485 to the higher Spo2 range) and had a median gestational age of 26 weeks (interquartile range, 25-27 weeks) and a mean birth weight of 832 g (SD, 190 g). The primary outcome occurred in 1191 of 2228 infants (53.5%) in the lower Spo2 target group and 1150 of 2229 infants (51.6%) in the higher Spo2 target group (risk difference, 1.7% [95% CI, -1.3% to 4.6%]; relative risk [RR], 1.04 [95% CI, 0.98 to 1.09], P = .21). Of the 16 secondary outcomes, 11 were null, 2 significantly favored the lower Spo2 target group, and 3 significantly favored the higher Spo2 target group. Death occurred in 484 of 2433 infants (19.9%) in the lower Spo2 target group and 418 of 2440 infants (17.1%) in the higher Spo2 target group (risk difference, 2.8% [95% CI, 0.6% to 5.0%]; RR, 1.17 [95% CI, 1.04 to 1.31], P = .01). Treatment for retinopathy of prematurity was administered to 220 of 2020 infants (10.9%) in the lower Spo2 target group and 308 of 2065 infants (14.9%) in the higher Spo2 target group (risk difference, -4.0% [95% CI, -6.1% to -2.0%]; RR, 0.74 [95% CI, 0.63 to 0.86], P < .001). Severe necrotizing enterocolitis occurred in 227 of 2464 infants (9.2%) in the lower Spo2 target group and 170 of 2465 infants (6.9%) in the higher Spo2 target group (risk difference, 2.3% [95% CI, 0.8% to 3.8%]; RR, 1.33 [95% CI, 1.10 to 1.61], P = .003).

Conclusions and Relevance:

In this prospectively planned meta-analysis of individual participant data from extremely preterm infants, there was no significant difference between a lower Spo2 target range compared with a higher Spo2 target range on the primary composite outcome of death or major disability at a corrected age of 18 to 24 months. The lower Spo2 target range was associated with a higher risk of death and necrotizing enterocolitis, but a lower risk of retinopathy of prematurity treatment.

PMID:
29872859
PMCID:
PMC6583054
DOI:
10.1001/jama.2018.5725
[Indexed for MEDLINE]
Free PMC Article

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