TORPIDO 30/60 Trial Compares Initial Oxygen in Preterm Resuscitation

Key Takeaways

• The primary composite outcome was similar between the two starting FiO2 groups.
• This was a multicountry randomized comparison across 31 maternity hospitals in 6 countries among infants due at 23 to 28 weeks' gestation.
• Escalation to FiO2 of 1.0 occurred at similar rates, and investigators concluded that starting at 0.6 did not affect the risk of the primary outcome versus 0.3.

In infants due at 23 to 28 weeks' gestation, the TORPIDO 30/60 randomized clinical trial compared starting resuscitation with FiO2 0.6 or 0.3 and found similar rates of death or brain injury at 36 weeks' corrected gestational age. The reported effect estimate for the primary composite outcome was a relative risk of 0.98, with a 95% CI from 0.89 to 1.09. This multicountry trial did not show a measurable difference between the two starting oxygen strategies on its main endpoint.

Researchers randomized 1641 newborns in a 1:1 design shortly before birth across 31 maternity hospitals in 6 countries between September 2018 and September 2024. Infants were assigned to an initial FiO2 of 0.6 or 0.3, then had oxygen adjusted to standard pulse oximetry saturation targets during the first 10 minutes or for clinical needs. Clinicians and outcome assessors were not blinded to group assignment; among newborns included in the primary analysis, 54% were female. The primary endpoint was death and brain injury assessed at 36 weeks' corrected gestational age.

The primary analysis included 728 newborns assigned to FiO2 0.6 and 741 assigned to FiO2 0.3 after 172 newborns were excluded. Most exclusions reflected birth after 28 weeks' gestation or transfer to another hospital before birth. Primary outcome information was available for 1423 newborns, representing 96.9% of the analyzed cohort. Death or brain injury occurred in 330 of 703 newborns in the FiO2 0.6 group and 344 of 720 in the FiO2 0.3 group, with a relative risk of 0.98. The findings were closely aligned between groups in the analyzed population.

Escalation to FiO2 of 1.0 was also similar, occurring in 41% of newborns assigned to FiO2 0.6 and 38% assigned to FiO2 0.3. Investigators concluded that starting resuscitation with FiO2 0.6, rather than 0.3, did not affect the risk of death or brain injury at 36 weeks' corrected gestational age in infants born at 23 to 28 weeks.