Targeted oxygenation in the respiratory care of premature infants at delivery-effects on outcome: a randomised controlled trial (Torpido 3060) study protocol.

Abstract

Introduction: The safest oxygen levels needed for preterm infant respiratory support at birth are uncertain. We aimed to compare the outcomes of infants up to 28⁶ weeks gestation who had respiratory care initiated at birth with fractional inspired oxygen (FiO₂) 0.3 or 0.6, which was adjusted to meet specific oxygen saturations (SpO₂).

Methods: This randomised controlled phase III trial was stratified by (1) site, (2) gestation and (3) multiplicity. Infants between 23+0 to 28+6 weeks gestation were randomised to initial respiratory support with FiO₂ 0.3 or 0.6, adjusted to meet common SpO₂ targets for the first 10 min.

Primary outcome: Survival to 36 weeks gestation without documented brain injury.

Assessments: FiO₂, SpO₂ and heart rate were recorded each minute from delivery for 10 min. Assessments were obtained at baseline, 36 weeks, discharge and at 2 years corrected gestation, along with a parent questionnaire.

Statistical analysis plan: Assuming 32% of infants would die or survive with brain injury by 36 weeks, 735 infants per arm (1470 total) were needed to detect a risk difference of 8% (25% relative risk reduction), with 10% non-adherence to protocol, 85% β and 5% α.

Ethics: Approved by the John Hunter Human Research Ethics Committee (2019/ETH/3837) for waiver of consent for all Australian sites for randomised allocation and primary outcome.

Conclusion: Recruitment started in 2018 and was achieved on 30 September 2024. The Data and Safety Committee review found no major safety concerns at 50% recruitment.

Trial registration number: ACTRN 12618000879268.