Positive end-expiratory pressure levels during resuscitation of preterm infants at birth (POLAR): study protocol for a randomised controlled trial

Abstract Background The most effective and safe level of positive end-expiratory pressure (PEEP) during stabilisation at birth of extremely preterm infants is unknown. In observational studies, an initial high PEEP level, then titrated to response (dynamic PEEP strategy), improved clinically relevant outcomes compared with current practice using a static, and lower, PEEP level. The Positive End-Expiratory Pressure Levels during Resuscitation of Preterm Infants at Birth (POLAR) trial will evaluate a novel dynamic PEEP strategy at birth. Methods In an international multicentre prospective open-label randomised controlled trial, we will randomise extremely preterm infants who require respiratory support from birth to either dynamic PEEP or a static PEEP. The primary outcomes are death or bronchopulmonary dysplasia at 36 weeks’ postmenstrual age. The experimental intervention of a dynamic PEEP strategy commences at 8 cmH 2 O, but individualised to clinical need to a maximum PEEP 12 cmH 2 O during stabilisation in the delivery room. The control arm is a standard, static PEEP (5–6 cmH 2 O). Important short-term respiratory morbidity and potential harm outcomes in the first 10 days after birth are pre-specified secondary outcomes. Trial registration www.clinicaltrials.gov , Trial Identifier NCT04372953, Registered 4 May 2020. Impact The most effective and safe level of positive end-expiratory pressure (PEEP) during stabilisation at birth of extremely preterm infants remains unknown. The international multicentre randomised controlled Positive End-Expiratory Pressure Levels during Resuscitation of Preterm Infants at Birth (POLAR) trial is designed to evaluate a novel dynamic PEEP strategy. The POLAR Trial will compare starting at 8 cmH 2 O PEEP at birth, then titrated between 8 and 12 cmH 2 O to response, against a static, lower, 6 cmH 2 O PEEP reflecting current practice. We plan to recruit 906 extremely preterm infants from birth. Reducing death or bronchopulmonary dysplasia (primary outcome) would represent a major advance in neonatal care.