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

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.