Resuscitation of term or near term infants at birth with air or 100% oxygen (Resair 3) A Randomised Controlled Trial

Resair 3 is a phase 3 pragmatic multicentre, consent waiver, cluster randomised cross-over study of 51 hospitals in 9 countries that will recruit 481,774 term or near term infants (gestation >35 weeks) within 12 months to initial respiratory support with either air (21% O2) or pure (100% O2). O2 concentrations will be titrated according to preductal O2 saturations (SpO2) of healthy, full-term infants (1). The primary outcome is the need for advanced resuscitation interventions (one or more of the following: 1. Endotracheal intubation/supraglottic airway 2. Cardiac compressions 3. Adrenaline) and death before hospital discharge. Resair 3 will use interventions and data collection methods that are part of routine care. The hypothesis is that initiating resuscitation of term/near term infants with 100% oxygen and then titrating according to clinical condition and oxygen saturations will lead to reduction in the need for advanced resuscitation interventions and death before hospital discharge, compared to initiating resuscitation with 21% oxygen and then titrating upwards.