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

Journal Article


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.

UOW Authors


  •   Oei, Ju Lee (external author)
  •   Saugstad, Ola (external author)
  •   Lui, Kei (external author)
  •   Wright, Ian
  •   Smyth, John (external author)
  •   Craven, P D. (external author)
  •   Wang, Yueping (external author)
  •   McMullan, Rowena (external author)
  •   Coates, Elisabeth (external author)
  •   Ward, Meredith (external author)
  •   Mishra, Parag (external author)
  •   de Waal, Koert (external author)
  •   Travadi, Javeed (external author)
  •   See, Kwee (external author)
  •   Cheah, Irene (external author)
  •   Lim, Kai
  •   Choo, Yao (external author)
  •   Kamar, Azanna (external author)
  •   Cheah, Fook (external author)
  •   Masoud, Ahmed (external author)
  •   Tarnow-Mordi, William O. (external author)

Publication Date


  • 2017

Citation


  • Oei, J., Saugstad, O., Lui, K., Wright, I., Smyth, J. P., Craven, P., Wang, Y. Alex., McMullan, R., Coates, E., Ward, M., Mishra, P., De Waal, K., Travadi, J., See, K. Ching., Cheah, I. G.S., Lim, C. Theam., Choo, Y. Mun., Kamar, A. Ahmad., Cheah, F. Choe., Masoud, A. & Tarnow-Mordi, W. (2017). Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial. Pediatrics, 139 (1), 1-11.

Scopus Eid


  • 2-s2.0-85009083436

Ro Metadata Url


  • http://ro.uow.edu.au/ihmri/1061

Has Global Citation Frequency


Number Of Pages


  • 10

Start Page


  • 1

End Page


  • 11

Volume


  • 139

Issue


  • 1

Place Of Publication


  • United States

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.

UOW Authors


  •   Oei, Ju Lee (external author)
  •   Saugstad, Ola (external author)
  •   Lui, Kei (external author)
  •   Wright, Ian
  •   Smyth, John (external author)
  •   Craven, P D. (external author)
  •   Wang, Yueping (external author)
  •   McMullan, Rowena (external author)
  •   Coates, Elisabeth (external author)
  •   Ward, Meredith (external author)
  •   Mishra, Parag (external author)
  •   de Waal, Koert (external author)
  •   Travadi, Javeed (external author)
  •   See, Kwee (external author)
  •   Cheah, Irene (external author)
  •   Lim, Kai
  •   Choo, Yao (external author)
  •   Kamar, Azanna (external author)
  •   Cheah, Fook (external author)
  •   Masoud, Ahmed (external author)
  •   Tarnow-Mordi, William O. (external author)

Publication Date


  • 2017

Citation


  • Oei, J., Saugstad, O., Lui, K., Wright, I., Smyth, J. P., Craven, P., Wang, Y. Alex., McMullan, R., Coates, E., Ward, M., Mishra, P., De Waal, K., Travadi, J., See, K. Ching., Cheah, I. G.S., Lim, C. Theam., Choo, Y. Mun., Kamar, A. Ahmad., Cheah, F. Choe., Masoud, A. & Tarnow-Mordi, W. (2017). Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial. Pediatrics, 139 (1), 1-11.

Scopus Eid


  • 2-s2.0-85009083436

Ro Metadata Url


  • http://ro.uow.edu.au/ihmri/1061

Has Global Citation Frequency


Number Of Pages


  • 10

Start Page


  • 1

End Page


  • 11

Volume


  • 139

Issue


  • 1

Place Of Publication


  • United States