Despite decades of neonatal research, the optimal fraction of inspired oxygen (FiO₂) for resuscitating very preterm infants remains an area of uncertainty. While clinicians aim to avoid both hypoxia and hyperoxia, clear evidence guiding the choice of initial oxygen concentration has been limited. The TORPIDO 30/60 trial sought to address this question by comparing outcomes between two commonly used starting FiO₂ levels.
Conducted across 31 maternity hospitals in six countries, the trial enrolled newborns expected to deliver between 23 and 28 weeks of gestation. Infants with congenital conditions that could affect survival or neurodevelopment were excluded. Randomization occurred shortly before birth, assigning infants to begin resuscitation with either FiO₂ 0.6 or FiO₂ 0.3. Oxygen levels were then adjusted during the first 10 minutes of life according to standard saturation targets. The study spanned from September 2018 to September 2024, with follow-up continuing through 2026.
The trial led to the following findings:
- Out of 1641 infants randomized, 1469 were included in the primary analysis after exclusions.
- Baseline characteristics were comparable between the two oxygen groups, and clinicians were aware of the assigned FiO₂ levels.
- The need to escalate oxygen to FiO₂ 1.0 was similar in both groups—41% in the FiO₂ 0.6 group and 38% in the FiO₂ 0.3 group—indicating that initial oxygen level did not significantly influence escalation requirements.
- The primary outcome of death or brain injury by 36 weeks’ corrected gestational age occurred in 46.9% of infants started on FiO₂ 0.6 and 47.8% of those started on FiO₂ 0.3, showing no statistically significant difference.
- A higher initial oxygen concentration did not improve or worsen major neonatal outcomes such as survival or risk of brain injury.
- Infants receiving FiO₂ 0.6 experienced fewer early episodes of hypoxemia and bradycardia and required less advanced resuscitation.
- However, these early physiological benefits did not lead to improvements in key clinical outcomes, underscoring persistent uncertainty about the most effective initial oxygen strategy for preterm infant resuscitation.
The researchers noted several limitations. The trial did not examine FiO₂ 0.4—a level commonly used in practice—nor did it test even higher starting levels such as FiO₂ 1.0. In addition, it was not designed to assess the influence of other delivery room interventions that affect oxygenation, such as delayed cord clamping or specific respiratory support techniques.
"Overall, the study adds important evidence to the ongoing debate and lays the groundwork for future trials. Determining whether different initial oxygen strategies can improve survival and long-term neurodevelopmental outcomes remains a critical question for neonatal care worldwide," the authors concluded.
Reference:
Oei JL, Kirby A, Travadi J, et al. Targeted Oxygen for Initial Resuscitation of Preterm Infants: The TORPIDO 30/60 Randomized Clinical Trial. JAMA. Published online December 10, 2025. doi:10.1001/jama.2025.23327
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