317 - Face Or Nasal Device Use in Early life, the FONDUE RCT in Very Preterm Infants

In recent studies, 90% of very preterm infants (VPTIs, < 32 weeks gestational age) will initiate spontaneous breathing within 1 minute of birth, yet over 60% receive positive pressure ventilation (PPV) and 25% will be intubated prior to transfer to the NICU. There is growing evidence that facemask application stimulates the trigeminal nerve reflex (TGR), resulting in a spiral of apnea, vocal cord closure, and hypoxia, further depressing newborn respiratory drive. Spontaneous breathing VPTIs are more likely to achieve a stable cardiopulmonary transition.

Objective: We hypothesize that a higher proportion of VPTIs who receive nasal continuous positive airway pressure (nCPAP) as the initial respiratory support at birth will maintain spontaneous breathing without escalation beyond CPAP (i.e., PPV, intubation, etc.) prior to NICU admission than infants who receive facemask CPAP (fCPAP).

Design/Methods:

This is a single-center, RCT at Monash Medical Centre, Melbourne, Australia, enrolling inborn infants 23^0/7 to 31^6/7 weeks gestation with antenatal consent. Both nCPAP and fCPAP are set up with independent circuits prior to all births of VPTIs (Figure A) with births attended by the neonatal team as standard of care. Immediately prior to birth, infants are randomized to initiate respiratory support with either nCPAP or fCPAP (Figure B and C). Treatment is considered successful if the infant is supported without escalation beyond CPAP between birth and admission to the NICU. Assuming an alpha of 0.05 and 90% power, and accounting for 10% of infants who are born with apnea and need immediate PPV, we plan to enroll 150 infants to detect an increase in the successful management of infants with CPAP only from 45% to 75%. Secondary outcomes include intubation rates and supplemental oxygen between birth and admission to the NICU.

Results: Since December 2020, 138/150 infants have been studied, including 45 infants born at < 28 weeks gestational age. Enrolment in the study will be complete by March 2023. An independent data safety monitoring committee evaluated the trial for safety after studying 80 infants, and determined the trial to be safe and recommended completion as planned.

Conclusion(s):

This is the first RCT to compare nasal versus facemask CPAP as the initial mode of respiratory support immediately after birth to promote spontaneous breathing. Supporting spontaneous breathing in VPTIs at birth may improve clinical stability and reduce the need to escalate care with risky procedures and supplemental oxygen at birth. Nasal CPAP may be more effective than facemask CPAP to maintain spontaneous breathing at birth.