Valerie Thamrin1, Ola D Saugstad2, William Tarnow-Mordi3, Yueping Alex Wang4, Kei Lui5, Ian M Wright6, Koert De Waal7, Javeed Travadi7, John P Smyth8, Paul Craven7, Rowena McMullan9, Elisabeth Coates10, Meredith Ward5, Parag Mishra5, Kwee Ching See11, Irene G S Cheah12, Chin Theam Lim13, Yao Mun Choo13, Azanna Ahmad Kamar13, Fook Choe Cheah14, Ahmed Masoud15, Ju Lee Oei16. 1. School of Women's and Children's Health, The University of New South Wales, Sydney, NSW, Australia. 2. Department of Pediatric Research, The University of Oslo, Oslo, Norway. 3. NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia; Westmead International Network for Neonatal Education and Research, Sydney, NSW, Australia. 4. Faculty of Health, University of Technology Sydney, Sydney, NSW, Australia. 5. School of Women's and Children's Health, The University of New South Wales, Sydney, NSW, Australia; Department of Newborn Care, The Royal Hospital for Women, Sydney, NSW, Australia. 6. Illawarra Health and Medical Research Institute and Graduate School of Medicine, The University of Wollongong, Wollongong, NSW, Australia; Hunter Medical Research Institute, University of Newcastle, Newcastle, NSW, Australia. 7. Hunter Medical Research Institute, University of Newcastle, Newcastle, NSW, Australia; Department of Neonatology, The John Hunter Hospital, Newcastle, NSW, Australia. 8. School of Women's and Children's Health, The University of New South Wales, Sydney, NSW, Australia; Department of Pediatric Research, The University of Oslo, Oslo, Norway. 9. Department of Neonatology, Royal Prince Alfred Hospital, Sydney, NSW, Australia. 10. NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia. 11. Department of Neonatology, Sungai Buloh Hospital, Selangor, Malaysia. 12. Department of Neonatology, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia. 13. Department of Neonatology, University of Malaya Medical Centre, Kuala Lumpur, Malaysia. 14. Department of Paediatrics, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia. 15. Hamad Medical Corporation, Doha, Qatar. 16. School of Women's and Children's Health, The University of New South Wales, Sydney, NSW, Australia; NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia; Department of Newborn Care, The Royal Hospital for Women, Sydney, NSW, Australia. Electronic address: j.oei@unsw.edu.au.
Abstract
OBJECTIVE: To determine rates of death or neurodevelopmental impairment (NDI) at 2 years corrected age (primary outcome) in children <32 weeks' gestation randomized to initial resuscitation with a fraction of inspired oxygen (FiO2) value of 0.21 or 1.0. STUDY DESIGN: Blinded assessments were conducted at 2-3 years corrected age with the Bayley Scales of Infant and Toddler Development, Third Edition or the Ages and Stages Questionnaire by intention to treat. RESULTS: Of the 290 children enrolled, 40 could not be contacted and 10 failed to attend appointments. Among the 240 children for whom outcomes at age 2 years were available, 1 child had a lethal congenital anomaly, 1 child had consent for follow-up withdrawn, and 23 children died. The primary outcome, which was available in 238 (82%) of those randomized, occurred in 47 of the 117 (40%) children assigned to initial FiO2 0.21 and in 38 of the 121 (31%) assigned to initial FiO2 1.0 (OR, 1.47; 95% CI, 0.86-2.5; P = .16). No difference in NDI was found in 215 survivors randomized to FiO2 0.21 vs 1.0 (OR, 1.26; 95% CI, 0.70-2.28; P = .11). In post hoc exploratory analyses in the whole cohort, children with a 5-minute blood oxygen saturation (SpO2) <80% were more likely to die or to have NDI (OR, 1.85; 95% CI, 1.07-3.2; P = .03). CONCLUSIONS: Initial resuscitation of infants <32 weeks' gestation with initial FiO2 0.21 had no significant effect on death or NDI compared with initial FiO2 1.0. Further evaluation of optimum initial FiO2, including SpO2 targeting, in a large randomized controlled trial is needed. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Network Registry ACTRN 12610001059055 and the National Malaysian Research Registry NMRR-07-685-957.
RCT Entities:
OBJECTIVE: To determine rates of death or neurodevelopmental impairment (NDI) at 2 years corrected age (primary outcome) in children <32 weeks' gestation randomized to initial resuscitation with a fraction of inspired oxygen (FiO2) value of 0.21 or 1.0. STUDY DESIGN: Blinded assessments were conducted at 2-3 years corrected age with the Bayley Scales of Infant and Toddler Development, Third Edition or the Ages and Stages Questionnaire by intention to treat. RESULTS: Of the 290 children enrolled, 40 could not be contacted and 10 failed to attend appointments. Among the 240 children for whom outcomes at age 2 years were available, 1 child had a lethal congenital anomaly, 1 child had consent for follow-up withdrawn, and 23 children died. The primary outcome, which was available in 238 (82%) of those randomized, occurred in 47 of the 117 (40%) children assigned to initial FiO2 0.21 and in 38 of the 121 (31%) assigned to initial FiO2 1.0 (OR, 1.47; 95% CI, 0.86-2.5; P = .16). No difference in NDI was found in 215 survivors randomized to FiO2 0.21 vs 1.0 (OR, 1.26; 95% CI, 0.70-2.28; P = .11). In post hoc exploratory analyses in the whole cohort, children with a 5-minute blood oxygen saturation (SpO2) <80% were more likely to die or to have NDI (OR, 1.85; 95% CI, 1.07-3.2; P = .03). CONCLUSIONS: Initial resuscitation of infants <32 weeks' gestation with initial FiO2 0.21 had no significant effect on death or NDI compared with initial FiO2 1.0. Further evaluation of optimum initial FiO2, including SpO2 targeting, in a large randomized controlled trial is needed. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Network Registry ACTRN 12610001059055 and the National Malaysian Research Registry NMRR-07-685-957.
Authors: Vishal Kapadia; Ju Lee Oei; Neil Finer; Wade Rich; Yacov Rabi; Ian M Wright; Denise Rook; Marijn J Vermeulen; William O Tarnow-Mordi; John P Smyth; Kei Lui; Steven Brown; Ola D Saugstad; Maximo Vento Journal: Resuscitation Date: 2021-08-20 Impact factor: 6.251
Authors: Anup C Katheria; Jeff M Szychowski; Jochen Essers; Marc R Mendler; Eugene M Dempsey; Georg M Schmölzer; Kathy Arnell; Wade D Rich; Kasim Hassen; Phillip Allman; Michael Varner; Gary R Cutter; Neil Finer Journal: J Pediatr Date: 2020-05-29 Impact factor: 4.406
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