Brian A Darlow1, Simone L Marschner2, Mark Donoghoe2, Malcolm R Battin3, Roland S Broadbent4, Mark J Elder5, Michael P Hewson6, Michael P Meyer7, Alpana Ghadge2, Patricia Graham8, Nicolette J McNeill8, Carl A Kuschel9, William O Tarnow-Mordi10. 1. Department of Pediatrics, University of Otago, Christchurch, New Zealand. Electronic address: brian.darlow@otago.ac.nz. 2. National Heath and Medical Research Council Clinical Trials Center, University of Sydney, Sydney, Australia. 3. Newborn Services, Auckland City Hospital, Auckland, New Zealand. 4. Women's and Children's Health, University of Otago, Dunedin, New Zealand. 5. Academic Department of Surgery, University of Otago, Christchurch, New Zealand. 6. Neonatal Intensive Care Unit, Wellington Regional Hospital, Wellington South, New Zealand. 7. KidzFirst, Middlemore Hospital, Otahuhu, Auckland, New Zealand. 8. Department of Pediatrics, University of Otago, Christchurch, New Zealand. 9. Newborn Services, Auckland City Hospital, Auckland, New Zealand; Neonatal Services, The Royal Women's Hospital, Melbourne, Victoria, Australia. 10. WINNER Center for Newborn Research, National Health and Medical Research Council Clinical Trials Center, University of Sydney, Sydney, Australia.
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.
RCT Entities:
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.
Authors: Brenda B Poindexter; Rui Feng; Barbara Schmidt; Judy L Aschner; Roberta A Ballard; Aaron Hamvas; Anne Marie Reynolds; Pamela A Shaw; Alan H Jobe Journal: Ann Am Thorac Soc Date: 2015-12
Authors: Hannah C Glass; Andrew T Costarino; Stephen A Stayer; Claire M Brett; Franklyn Cladis; Peter J Davis Journal: Anesth Analg Date: 2015-06 Impact factor: 5.108
Authors: Rosemary D Higgins; Alan H Jobe; Marion Koso-Thomas; Eduardo Bancalari; Rose M Viscardi; Tina V Hartert; Rita M Ryan; Suhas G Kallapur; Robin H Steinhorn; Girija G Konduri; Stephanie D Davis; Bernard Thebaud; Ronald I Clyman; Joseph M Collaco; Camilia R Martin; Jason C Woods; Neil N Finer; Tonse N K Raju Journal: J Pediatr Date: 2018-03-16 Impact factor: 4.406