Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO2 0.21 or 1.0

Valerie Thamrin, Ola D. Saugstad, William Tarnow-Mordi, Yueping Alex Wang, Kei Lui, Ian M. Wright, Koert De Waal, Javeed Travadi, John P. Smyth, Paul Craven, Rowena McMullan, Elisabeth Coates, Meredith Ward, Parag Mishra, Kwee Ching See, Irene G.S. Cheah, Chin Theam Lim, Yao Mun Choo, Azanna Ahmad Kamar, Cheah Fook ChoeAhmed Masoud, Ju Lee Oei

Research output: Contribution to journalArticle

7 Citations (Scopus)

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whom outcomes at age 2 years were available, 1 child had a lethal congenital anomaly, 1 child had consent for follow-up withdrawn, and 23 children died.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.

Original languageEnglish
Pages (from-to)55-61.e1
JournalJournal of Pediatrics
Volume201
DOIs
Publication statusPublished - 1 Oct 2018

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Random Allocation
Premature Infants
Resuscitation
Registries
Oxygen
Pregnancy
Child Development
New Zealand
Survivors
Appointments and Schedules
Randomized Controlled Trials
Clinical Trials
Mortality
Research

Keywords

  • death
  • neurodevelopmental injury
  • oxygen
  • preterm
  • resuscitation

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Thamrin, V., Saugstad, O. D., Tarnow-Mordi, W., Wang, Y. A., Lui, K., Wright, I. M., ... Oei, J. L. (2018). Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO2 0.21 or 1.0. Journal of Pediatrics, 201, 55-61.e1. https://doi.org/10.1016/j.jpeds.2018.05.053

Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO2 0.21 or 1.0. / Thamrin, Valerie; Saugstad, Ola D.; Tarnow-Mordi, William; Wang, Yueping Alex; Lui, Kei; Wright, Ian M.; De Waal, Koert; Travadi, Javeed; Smyth, John P.; Craven, Paul; McMullan, Rowena; Coates, Elisabeth; Ward, Meredith; Mishra, Parag; See, Kwee Ching; Cheah, Irene G.S.; Lim, Chin Theam; Choo, Yao Mun; Kamar, Azanna Ahmad; Fook Choe, Cheah; Masoud, Ahmed; Oei, Ju Lee.

In: Journal of Pediatrics, Vol. 201, 01.10.2018, p. 55-61.e1.

Research output: Contribution to journalArticle

Thamrin, V, Saugstad, OD, Tarnow-Mordi, W, Wang, YA, Lui, K, Wright, IM, De Waal, K, Travadi, J, Smyth, JP, Craven, P, McMullan, R, Coates, E, Ward, M, Mishra, P, See, KC, Cheah, IGS, Lim, CT, Choo, YM, Kamar, AA, Fook Choe, C, Masoud, A & Oei, JL 2018, 'Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO2 0.21 or 1.0', Journal of Pediatrics, vol. 201, pp. 55-61.e1. https://doi.org/10.1016/j.jpeds.2018.05.053
Thamrin, Valerie ; Saugstad, Ola D. ; Tarnow-Mordi, William ; Wang, Yueping Alex ; Lui, Kei ; Wright, Ian M. ; De Waal, Koert ; Travadi, Javeed ; Smyth, John P. ; Craven, Paul ; McMullan, Rowena ; Coates, Elisabeth ; Ward, Meredith ; Mishra, Parag ; See, Kwee Ching ; Cheah, Irene G.S. ; Lim, Chin Theam ; Choo, Yao Mun ; Kamar, Azanna Ahmad ; Fook Choe, Cheah ; Masoud, Ahmed ; Oei, Ju Lee. / Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO2 0.21 or 1.0. In: Journal of Pediatrics. 2018 ; Vol. 201. pp. 55-61.e1.
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AU - Thamrin, Valerie

AU - Saugstad, Ola D.

AU - Tarnow-Mordi, William

AU - Wang, Yueping Alex

AU - Lui, Kei

AU - Wright, Ian M.

AU - De Waal, Koert

AU - Travadi, Javeed

AU - Smyth, John P.

AU - Craven, Paul

AU - McMullan, Rowena

AU - Coates, Elisabeth

AU - Ward, Meredith

AU - Mishra, Parag

AU - See, Kwee Ching

AU - Cheah, Irene G.S.

AU - Lim, Chin Theam

AU - Choo, Yao Mun

AU - Kamar, Azanna Ahmad

AU - Fook Choe, Cheah

AU - Masoud, Ahmed

AU - Oei, Ju Lee

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N2 - 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.

AB - 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.

KW - death

KW - neurodevelopmental injury

KW - oxygen

KW - preterm

KW - resuscitation

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