Ju Lee Oei1,2,3, Ola D Saugstad4, Kei Lui5,2, Ian M Wright6,7,8, John P Smyth5,2, Paul Craven8, Yueping Alex Wang9, Rowena McMullan10, Elisabeth Coates3, Meredith Ward5,2, Parag Mishra5,2, Koert De Waal8, Javeed Travadi8, Kwee Ching See11, Irene G S Cheah12, Chin Theam Lim13, Yao Mun Choo13, Azanna Ahmad Kamar13, Fook Choe Cheah14, Ahmed Masoud15, William Tarnow-Mordi3. 1. School of Women's and Children's Health, the University of New South Wales, Australia; j.oei@unsw.edu.au. 2. Department of Newborn Care, Royal Hospital for Women, Australia. 3. Westmead International Network for Neonatal Education and Research, (WINNER Centre), NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia. 4. Department of Pediatric Research, Olso University Hospital, University of Oslo, Oslo, Norway. 5. School of Women's and Children's Health, the University of New South Wales, Australia. 6. Illawarra Health and Medical Research Institute and Graduate Medicine, The University of Wollongong, Australia. 7. Hunter Medical Research Institute, University of Newcastle, Australia. 8. Department of Neonatology, John Hunter Hospital, Australia. 9. Faculty of Health, University of Technology Sydney, Australia. 10. Department of Neonatology, Royal Prince Alfred Hospital, Australia. 11. Sungai Buloh Hospital, Selangor, Malaysia. 12. Department of Paediatrics, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia. 13. Department of Paediatrics, University Malaya, Kuala Lumpur, Malaysia. 14. Department of Paediatrics, Universiti Kebangsaan Malaysia Medical Center, Kuala Lumpar, Malaysia; and. 15. Hamad Medical Corporation, Qatar.
Abstract
BACKGROUND AND OBJECTIVES:Lower concentrations of oxygen (O2) (≤30%) are recommended for preterm resuscitation to avoid oxidative injury and cerebral ischemia. Effects on long-term outcomes are uncertain. We aimed to determine the effects of using room air (RA) or 100% O2 on the combined risk of death and disabilityat 2 years in infants <32 weeks' gestation. METHODS: A randomized, unmasked study designed to determine major disability and deathat 2 years in infants <32 weeks' gestation after delivery room resuscitation was initiated with either RA or 100% O2 and which were adjusted to target pulse oximetry of 65% to 95% at 5 minutes and 85% to 95% until NICU admission. RESULTS: Of 6291 eligible patients, 292 were recruited and 287 (mean gestation: 28.9 weeks) were included in the analysis (RA: n = 144; 100% O2: n = 143). Recruitment ceased in June 2014, per the recommendations of the Data and Safety Monitoring Committee owing to loss of equipoise for the use of 100% O2. In non-prespecified analyses, infants <28 weeks who received RA resuscitation had higher hospital mortality (RA: 10 of 46 [22%]; than those given 100% O2: 3 of 54 [6%]; risk ratio: 3.9 [95% confidence interval: 1.1-13.4]; P = .01). Respiratory failure was the most common cause of death (n = 13). CONCLUSIONS: Using RA to initiate resuscitation was associated with an increased risk of death in infants <28 weeks' gestation. This study was not a prespecified analysis, and it was underpowered to address this post hoc hypothesis reliably. Additional data are needed.
RCT Entities:
BACKGROUND AND OBJECTIVES: Lower concentrations of oxygen (O2) (≤30%) are recommended for preterm resuscitation to avoid oxidative injury and cerebral ischemia. Effects on long-term outcomes are uncertain. We aimed to determine the effects of using room air (RA) or 100% O2 on the combined risk of death and disability at 2 years in infants <32 weeks' gestation. METHODS: A randomized, unmasked study designed to determine major disability and death at 2 years in infants <32 weeks' gestation after delivery room resuscitation was initiated with either RA or 100% O2 and which were adjusted to target pulse oximetry of 65% to 95% at 5 minutes and 85% to 95% until NICU admission. RESULTS: Of 6291 eligible patients, 292 were recruited and 287 (mean gestation: 28.9 weeks) were included in the analysis (RA: n = 144; 100% O2: n = 143). Recruitment ceased in June 2014, per the recommendations of the Data and Safety Monitoring Committee owing to loss of equipoise for the use of 100% O2. In non-prespecified analyses, infants <28 weeks who received RA resuscitation had higher hospital mortality (RA: 10 of 46 [22%]; than those given 100% O2: 3 of 54 [6%]; risk ratio: 3.9 [95% confidence interval: 1.1-13.4]; P = .01). Respiratory failure was the most common cause of death (n = 13). CONCLUSIONS: Using RA to initiate resuscitation was associated with an increased risk of death in infants <28 weeks' gestation. This study was not a prespecified analysis, and it was underpowered to address this post hoc hypothesis reliably. Additional data are needed.
Authors: Vishal S Kapadia; Charitharth V Lal; Venkat Kakkilaya; Roy Heyne; Rashmin C Savani; Myra H Wyckoff Journal: J Pediatr Date: 2017-12 Impact factor: 4.406