The Face Or Nasal Device Use in Early life, the FONDUE trial

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Non-invasive, continuous positive airway pressure (CPAP) immediately after birth of a very preterm infant (“VPTI,” <32 weeks’ gestational age at birth) is currently recommended as the standard of care during the stabilisation of preterm infants following birth. After birth, the infant must rapidly transition from a fluid filled lung, and dependence on the placenta for oxygenation and the elimination of carbon dioxide, to an aerated lung that successfully exchanges gases. CPAP supports the transition from fetal to newborn physiology by providing a distending pressure to the lung, thus maintaining a functional residual capacity (FRC) and enabling oxygenation and ventilation. Preterm infants who are successfully managed with CPAP versus mechanical ventilation via an endotracheal tube have increased survival without chronic lung disease, which improves long-term neurodevelopmental outcomes. Caffeine, and minimally invasive surfactant therapy (MIST) are other key treatments after admission to the NICU to avoid intubation and mechanical ventilation. Following stabilisation on CPAP, caffeine and MIST may be administered to further optimise respiratory support and reduce the risk of requiring intubation and mechanical ventilation, ultimately reducing the incidence of death and chronic lung disease in our patients. 97% of VPTIs at Monash require respiratory support to facilitate stabilisation. Current neonatal resuscitation training programs advocate a trial of CPAP via a facemask that covers the infant’s nose and mouth. An adequate seal is difficult to achieve and the use of a facemask has the additional adverse effect of high compressive forces being applied to the infant’s face and head during resuscitation regardless of which brand of facemask is used, and even with the use of adjunct respiratory monitoring. Ninety percent of VPTIs will initiate spontaneous breathing by 1 minute after birth. Despite VPTIs commonly having a good respiratory drive, respiratory support is nearly always indicated because of respiratory distress syndrome caused by the immature lungs. In this situation, facemask CPAP has a high failure rate due to stimulation of the trigeminal nerves which cause apnea, bradycardia, and hypoxia. Our multidisciplinary team has over a year of experience with nasal CPAP at birth and we have equipoise between providing initial respiratory support in the delivery room with nasal CPAP versus facemask CPAP. We believe that nasal CPAP may be a more effective method of supporting the VPTI than facemask CPAP, specifically maintaining adequate spontaneous breathing and reducing the need for PPV, supplemental oxygen, and intubation in the delivery room. We believe a randomised controlled trial is warranted to test this hypothesis, in order to improve outcomes for high-risk, preterm infants, inform local practice, and provide critically important evidence to the global neonatal community.