Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial

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

Research output: Contribution to journalArticle

35 Citations (Scopus)

Abstract

BACKGROUND AND OBJECTIVES: Lower concentrations of oxygen (O abstract 2) (≤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.

Original languageEnglish
Article numbere20161452
JournalPediatrics
Volume139
Issue number1
DOIs
Publication statusPublished - 1 Jan 2017

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Premature Infants
Resuscitation
Randomized Controlled Trials
Air
Oxygen
Pregnancy
Clinical Trials Data Monitoring Committees
Delivery Rooms
Oximetry
Hospital Mortality
Brain Ischemia
Respiratory Insufficiency
Cause of Death
Odds Ratio
Confidence Intervals
Safety
Wounds and Injuries

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Oei, J. L., Saugstad, O. D., Lui, K., Wright, I. M., Smyth, J. P., Craven, P., ... Tarnow-Mordi, W. (2017). Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial. Pediatrics, 139(1), [e20161452]. https://doi.org/10.1542/peds.2016-1452

Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial. / Oei, Ju Lee; Saugstad, Ola D.; Lui, Kei; Wright, Ian M.; Smyth, John P.; Craven, Paul; Wang, Yueping Alex; McMullan, Rowena; Coates, Elisabeth; Ward, Meredith; Mishra, Parag; De Waal, Koert; Travadi, Javeed; See, Kwee Ching; Cheah, Irene G S; Lim, Chin Theam; Choo, Yao Mun; Kamar, Azanna Ahmad; Fook Choe, Cheah; Masoud, Ahmed; Tarnow-Mordi, William.

In: Pediatrics, Vol. 139, No. 1, e20161452, 01.01.2017.

Research output: Contribution to journalArticle

Oei, JL, Saugstad, OD, Lui, K, Wright, IM, Smyth, JP, Craven, P, Wang, YA, McMullan, R, Coates, E, Ward, M, Mishra, P, De Waal, K, Travadi, J, See, KC, Cheah, IGS, Lim, CT, Choo, YM, Kamar, AA, Fook Choe, C, Masoud, A & Tarnow-Mordi, W 2017, 'Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial', Pediatrics, vol. 139, no. 1, e20161452. https://doi.org/10.1542/peds.2016-1452
Oei JL, Saugstad OD, Lui K, Wright IM, Smyth JP, Craven P et al. Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial. Pediatrics. 2017 Jan 1;139(1). e20161452. https://doi.org/10.1542/peds.2016-1452
Oei, Ju Lee ; Saugstad, Ola D. ; Lui, Kei ; Wright, Ian M. ; Smyth, John P. ; Craven, Paul ; Wang, Yueping Alex ; McMullan, Rowena ; Coates, Elisabeth ; Ward, Meredith ; Mishra, Parag ; De Waal, Koert ; Travadi, Javeed ; See, Kwee Ching ; Cheah, Irene G S ; Lim, Chin Theam ; Choo, Yao Mun ; Kamar, Azanna Ahmad ; Fook Choe, Cheah ; Masoud, Ahmed ; Tarnow-Mordi, William. / Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial. In: Pediatrics. 2017 ; Vol. 139, No. 1.
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abstract = "BACKGROUND AND OBJECTIVES: Lower concentrations of oxygen (O abstract 2) (≤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.",
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AU - Oei, Ju Lee

AU - Saugstad, Ola D.

AU - Lui, Kei

AU - Wright, Ian M.

AU - Smyth, John P.

AU - Craven, Paul

AU - Wang, Yueping Alex

AU - McMullan, Rowena

AU - Coates, Elisabeth

AU - Ward, Meredith

AU - Mishra, Parag

AU - De Waal, Koert

AU - Travadi, Javeed

AU - See, Kwee Ching

AU - Cheah, Irene G S

AU - Lim, Chin Theam

AU - Choo, Yao Mun

AU - Kamar, Azanna Ahmad

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N2 - BACKGROUND AND OBJECTIVES: Lower concentrations of oxygen (O abstract 2) (≤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.

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