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Background:  Infants are currently stabilized at birth with initial low FiO 2  which increases the risk of hypoxia and suppression of breathing in the first minutes after birth. We hypothesized that initiating stabilization at birth with a high O 2  concentration, followed by titration, would improve breathing effort when compared to a low O 2  concentration, followed by titration.   Methods:  In a bi-center randomized controlled trial, infants <30 weeks gestation were stabilized at birth with an initial O 2  concentration of 30 or 100%, followed by oxygen titration. Primary outcome was minute volume of spontaneous breathing. We also assessed tidal volumes, mean inspiratory flow rate (MIFR) and respiratory rate with a respiratory function monitor in the first 5 min after birth, and evaluated the duration of mask ventilation in the first 10 min after birth. Pulse oximetry was used to measure heart rate and SpO 2  values in the first 10 min. Hypoxemia was defined as SpO 2  < 25th percentile and hyperoxemia as SpO 2  >95%. 8-iso-prostaglandin F2α (8iPGF2α) was measured to assess oxidative stress in cord blood and 1 and 24 h after birth.   Results:  Fifty-two infants were randomized and recordings were obtained in 44 infants (100% O 2 -group:  n  = 20, 30% O 2 -group:  n  = 24). Minute volumes were significantly higher in the 100% O 2 -group (146.34 ± 112.68 mL/kg/min) compared to the 30% O 2 -group (74.43 ± 52.19 mL/kg/min),  p  = 0.014. Tidal volumes and MIFR were significantly higher in the 100% O 2 -group, while the duration of mask ventilation given was significantly shorter. Oxygenation in the first 5 min after birth was significantly higher in infants in the 100% O 2 -group [85 (64–93)%] compared to the 30% O 2 -group [58 (46–67)%],  p  < 0.001. The duration of hypoxemia was significantly shorter in the 100% O 2 -group, while the duration of hyperoxemia was not different between groups. There was no difference in oxidative stress marker 8iPGF2α between the groups.   Conclusion:  Initiating stabilization of preterm infants at birth with 100% O 2  led to higher breathing effort, improved oxygenation, and a shorter duration of mask ventilation as compared to 30% O 2 , without increasing the risk for hyperoxia or oxidative stress.   Clinical Trial Registration:  This study was registered in  www.trialregister.nl , with registration number NTR6878.

The Effect of Initial High vs. Low FiO2 on Breathing Effort in Preterm Infants at Birth: A Randomized Controlled Trial