Randomized controlled trial of oxygen saturation targets in very preterm infants: two year outcomes

Brian A. Darlow; Simone L. Marschner; Mark Donoghoe; Malcolm R. Battin; Roland S. Broadbent; Mark J. Elder; Michael P. Hewson; Michael P. Meyer; Alpana Ghadge; Patricia Graham; Nicolette J. McNeill; Carl A. Kuschel; William O. Tarnow-Mordi

doi:10.1016/j.jpeds.2014.01.017

Randomized controlled trial of oxygen saturation targets in very preterm infants: two year outcomes

Brian A. Darlow^*, Simone L. Marschner, Mark Donoghoe, Malcolm R. Battin, Roland S. Broadbent, Mark J. Elder, Michael P. Hewson, Michael P. Meyer, Alpana Ghadge, Patricia Graham, Nicolette J. McNeill, Carl A. Kuschel, William O. Tarnow-Mordi

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

77 Citations (Scopus)

Abstract

OBJECTIVE: To assess whether an oxygen saturation (Spo2) target of 85%-89% compared with 91%-95% reduced the incidence of the composite outcome of death or major disability at 2 years of age in infants born at <28 weeks' gestation.

STUDY DESIGN: A total 340 infants were randomized to a lower or higher target from <24 hours of age until 36 weeks' gestational age. Blinding was achieved by targeting a displayed Spo2 of 88%-92% using a saturation monitor offset by ±3% within the range 85%-95%. True saturations were displayed outside this range. Follow-up at 2 years' corrected age was by pediatric examination and formal neurodevelopmental assessment. Major disability was gross motor disability, cognitive or language delay, severe hearing loss, or blindness.

RESULTS: The primary outcome was known for 335 infants with 33 using surrogate language information. Targeting a lower compared with a higher Spo2 target range had no significant effect on the rate of death or major disability at 2 years' corrected age (65/167 [38.9%] vs 76/168 [45.2%]; relative risk 1.15, 95% CI 0.90-1.47) or any secondary outcomes. Death occurred in 25 (14.7%) and 27 (15.9%) of those randomized to the lower and higher target, respectively, and blindness in 0% and 0.7%.

CONCLUSIONS: Although there was no benefit or harm from targeting a lower compared with a higher saturation in this trial, further information will become available from the prospectively planned meta-analysis of this and 4 other trials comprising a total of nearly 5000 infants.

Original language	English
Pages (from-to)	30-35.e2
Number of pages	8
Journal	Journal of Pediatrics
Volume	165
Issue number	1
DOIs	https://doi.org/10.1016/j.jpeds.2014.01.017
Publication status	Published - Jul 2014
Externally published	Yes

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Darlow, B. A., Marschner, S. L., Donoghoe, M., Battin, M. R., Broadbent, R. S., Elder, M. J., Hewson, M. P., Meyer, M. P., Ghadge, A., Graham, P., McNeill, N. J., Kuschel, C. A., & Tarnow-Mordi, W. O. (2014). Randomized controlled trial of oxygen saturation targets in very preterm infants: two year outcomes. Journal of Pediatrics, 165(1), 30-35.e2. https://doi.org/10.1016/j.jpeds.2014.01.017

@article{da4d45f3c928408e8a5bef79cf361789,

title = "Randomized controlled trial of oxygen saturation targets in very preterm infants: two year outcomes",

abstract = "OBJECTIVE: To assess whether an oxygen saturation (Spo2) target of 85\%-89\% compared with 91\%-95\% reduced the incidence of the composite outcome of death or major disability at 2 years of age in infants born at <28 weeks' gestation.STUDY DESIGN: A total 340 infants were randomized to a lower or higher target from <24 hours of age until 36 weeks' gestational age. Blinding was achieved by targeting a displayed Spo2 of 88\%-92\% using a saturation monitor offset by ±3\% within the range 85\%-95\%. True saturations were displayed outside this range. Follow-up at 2 years' corrected age was by pediatric examination and formal neurodevelopmental assessment. Major disability was gross motor disability, cognitive or language delay, severe hearing loss, or blindness.RESULTS: The primary outcome was known for 335 infants with 33 using surrogate language information. Targeting a lower compared with a higher Spo2 target range had no significant effect on the rate of death or major disability at 2 years' corrected age (65/167 [38.9\%] vs 76/168 [45.2\%]; relative risk 1.15, 95\% CI 0.90-1.47) or any secondary outcomes. Death occurred in 25 (14.7\%) and 27 (15.9\%) of those randomized to the lower and higher target, respectively, and blindness in 0\% and 0.7\%.CONCLUSIONS: Although there was no benefit or harm from targeting a lower compared with a higher saturation in this trial, further information will become available from the prospectively planned meta-analysis of this and 4 other trials comprising a total of nearly 5000 infants.",

author = "Darlow, \{Brian A.\} and Marschner, \{Simone L.\} and Mark Donoghoe and Battin, \{Malcolm R.\} and Broadbent, \{Roland S.\} and Elder, \{Mark J.\} and Hewson, \{Michael P.\} and Meyer, \{Michael P.\} and Alpana Ghadge and Patricia Graham and McNeill, \{Nicolette J.\} and Kuschel, \{Carl A.\} and Tarnow-Mordi, \{William O.\}",

year = "2014",

month = jul,

doi = "10.1016/j.jpeds.2014.01.017",

language = "English",

volume = "165",

pages = "30--35.e2",

journal = "Journal of Pediatrics",

issn = "0022-3476",

publisher = "Elsevier",

number = "1",

}

Darlow, BA, Marschner, SL, Donoghoe, M, Battin, MR, Broadbent, RS, Elder, MJ, Hewson, MP, Meyer, MP, Ghadge, A, Graham, P, McNeill, NJ, Kuschel, CA & Tarnow-Mordi, WO 2014, 'Randomized controlled trial of oxygen saturation targets in very preterm infants: two year outcomes', Journal of Pediatrics, vol. 165, no. 1, pp. 30-35.e2. https://doi.org/10.1016/j.jpeds.2014.01.017

TY - JOUR

T1 - Randomized controlled trial of oxygen saturation targets in very preterm infants

T2 - two year outcomes

AU - Darlow, Brian A.

AU - Marschner, Simone L.

AU - Donoghoe, Mark

AU - Battin, Malcolm R.

AU - Broadbent, Roland S.

AU - Elder, Mark J.

AU - Hewson, Michael P.

AU - Meyer, Michael P.

AU - Ghadge, Alpana

AU - Graham, Patricia

AU - McNeill, Nicolette J.

AU - Kuschel, Carl A.

AU - Tarnow-Mordi, William O.

PY - 2014/7

Y1 - 2014/7

N2 - OBJECTIVE: To assess whether an oxygen saturation (Spo2) target of 85%-89% compared with 91%-95% reduced the incidence of the composite outcome of death or major disability at 2 years of age in infants born at <28 weeks' gestation.STUDY DESIGN: A total 340 infants were randomized to a lower or higher target from <24 hours of age until 36 weeks' gestational age. Blinding was achieved by targeting a displayed Spo2 of 88%-92% using a saturation monitor offset by ±3% within the range 85%-95%. True saturations were displayed outside this range. Follow-up at 2 years' corrected age was by pediatric examination and formal neurodevelopmental assessment. Major disability was gross motor disability, cognitive or language delay, severe hearing loss, or blindness.RESULTS: The primary outcome was known for 335 infants with 33 using surrogate language information. Targeting a lower compared with a higher Spo2 target range had no significant effect on the rate of death or major disability at 2 years' corrected age (65/167 [38.9%] vs 76/168 [45.2%]; relative risk 1.15, 95% CI 0.90-1.47) or any secondary outcomes. Death occurred in 25 (14.7%) and 27 (15.9%) of those randomized to the lower and higher target, respectively, and blindness in 0% and 0.7%.CONCLUSIONS: Although there was no benefit or harm from targeting a lower compared with a higher saturation in this trial, further information will become available from the prospectively planned meta-analysis of this and 4 other trials comprising a total of nearly 5000 infants.

AB - OBJECTIVE: To assess whether an oxygen saturation (Spo2) target of 85%-89% compared with 91%-95% reduced the incidence of the composite outcome of death or major disability at 2 years of age in infants born at <28 weeks' gestation.STUDY DESIGN: A total 340 infants were randomized to a lower or higher target from <24 hours of age until 36 weeks' gestational age. Blinding was achieved by targeting a displayed Spo2 of 88%-92% using a saturation monitor offset by ±3% within the range 85%-95%. True saturations were displayed outside this range. Follow-up at 2 years' corrected age was by pediatric examination and formal neurodevelopmental assessment. Major disability was gross motor disability, cognitive or language delay, severe hearing loss, or blindness.RESULTS: The primary outcome was known for 335 infants with 33 using surrogate language information. Targeting a lower compared with a higher Spo2 target range had no significant effect on the rate of death or major disability at 2 years' corrected age (65/167 [38.9%] vs 76/168 [45.2%]; relative risk 1.15, 95% CI 0.90-1.47) or any secondary outcomes. Death occurred in 25 (14.7%) and 27 (15.9%) of those randomized to the lower and higher target, respectively, and blindness in 0% and 0.7%.CONCLUSIONS: Although there was no benefit or harm from targeting a lower compared with a higher saturation in this trial, further information will become available from the prospectively planned meta-analysis of this and 4 other trials comprising a total of nearly 5000 infants.

UR - https://www.scopus.com/pages/publications/84903388236

U2 - 10.1016/j.jpeds.2014.01.017

DO - 10.1016/j.jpeds.2014.01.017

M3 - Article

C2 - 24560181

AN - SCOPUS:84903388236

SN - 0022-3476

VL - 165

SP - 30-35.e2

JO - Journal of Pediatrics

JF - Journal of Pediatrics

IS - 1

ER -

Randomized controlled trial of oxygen saturation targets in very preterm infants: two year outcomes

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