Non-invasive open lung strategy in delivery room: randomized controlled trial (OpenCPAP-DR).

UNLABELLED: The study aimed to compare the effects of individualized nasal continuous positive airway pressure (nCPAP) therapy using different positive end-expiratory pressure (PEEP) levels on heart rate, SpO2, and surfactant requirement in very preterm infants at birth. This multicenter, randomized controlled trial is designed in the settings of delivery room and level 3-4 neonatal intensive care units of two hospitals. Infants < 31 weeks of gestation were randomized to receive initial nCPAP pressures of 6 cmH2O for the standard and 8 cmH2O for the open CPAP groups. Unless the target heart rate and SpO2 were met, the pressures were increased to 8 for the standard group and 10 for the open CPAP group. FiO2 was titrated if the targets were not achieved. NIPPV and surfactant therapy indicated if FiO2 > 40%. The primary outcomes were SpO2/FiO2 ratio and Oxygen Saturation Index (OSI) at 5 and 10 min, as well as the need for surfactant within 72 h. A total of 145 infants were enrolled (standard CPAP, n = 76; open CPAP, n = 69). The need for PEEP adjustment to the upper limit was higher in the standard CPAP group. Although there was no difference in the S/F ratio after 5 or 10 min, the OSI was higher in the open CPAP group due to the higher pressure. There was no difference between the groups in terms of the other primary outcomes.

CONCLUSION

This randomized clinical trial evaluated the effects of different PEEP levels in the delivery room management of very preterm infants. Initiating CPAP support at 6 cmH2O, as commonly practiced, required escalation to higher pressures in nearly half of very preterm infants to achieve target oxygen saturation levels. These findings suggest that an individualized approach using higher initial pressures may facilitate more effective lung recruitment and warrant further investigation in the delivery room setting.

TRIAL REGISTRATION: Open lung strategy during non-invasive respiratory support of very preterm infants in the delivery room (OpenCPAP-DR), NCT05031650, 26 August 2021 https://clinicaltrials.gov/study/NCT05031650?term=Nuray%20duman&rank=1 , deidentified individual participant data will not be made available.

WHAT IS KNOWN: • There is no specific evidence-based pressure level for early nCPAP recommended in the delivery room for very preterm infants.

WHAT IS NEW: • When stabilizing very preterm infants in the delivery room, it has been found prudent to increase pressure rather than increase oxygen first when using nCPAP if the target oxygen saturation is not reached.