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Positive end-expiratory pressure levels during resuscitation of preterm infants at birth (POLAR): study protocol for
David G Tingay1,2,3, Laura Galletta4,5, Louise S Owen4,6,7
1Neonatal Research, Murdoch Children's Research Institute, Parkville, VIC, Australia. David.tingay@mcri.edu.au.
Insights
The POLAR trial investigates a dynamic positive end-expiratory pressure (PEEP) strategy for extremely preterm infants, aiming to reduce death or bronchopulmonary dysplasia. This approach uses higher, responsive PEEP levels during resuscitation compared to standard static PEEP.
Area of Science:
- Neonatal Resuscitation
- Respiratory Support in Preterm Infants
- Clinical Trial Methodology
Background:
- Optimal positive end-expiratory pressure (PEEP) for extremely preterm infants during stabilization at birth is undetermined.
- Observational studies suggest a dynamic PEEP strategy may improve outcomes compared to current static PEEP practices.
- The POLAR trial aims to evaluate a novel dynamic PEEP strategy in this vulnerable population.
Purpose of the Study:
- To assess the efficacy and safety of a dynamic PEEP strategy versus a static PEEP strategy in extremely preterm infants.
- To determine if dynamic PEEP reduces the incidence of death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age.
- To evaluate short-term respiratory morbidity and potential harm outcomes within the first 10 days of life.
Main Methods:
- International multicentre prospective open-label randomised controlled trial.
- Randomization of extremely preterm infants requiring respiratory support at birth to either dynamic PEEP or static PEEP.
- Dynamic PEEP strategy starts at 8 cmH2O, titrated to 12 cmH2O; static PEEP is 5-6 cmH2O.
Main Results:
- Primary outcome: death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age.
- Secondary outcomes: short-term respiratory morbidity and potential harm in the first 10 days.
- The trial is registered (NCT04372953) and aims to recruit 906 infants.
Conclusions:
- The POLAR trial will provide crucial data on the optimal PEEP strategy for extremely preterm infants.
- A successful dynamic PEEP strategy could significantly advance neonatal care by reducing mortality and morbidity.
- Findings will inform clinical practice guidelines for respiratory support at birth.
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 cmH2O, but individualised to clinical need to a maximum PEEP 12 cmH2O during stabilisation in the delivery room. The control arm is a standard, static PEEP (5-6 cmH2O). 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 cmH2O PEEP at birth, then titrated between 8 and 12 cmH2O to response, against a static, lower, 6 cmH2O 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.
