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.

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Journal
Pediatric Research
Published
2026-05-12
DOI
https://doi.org/10.1038/s41390-026-04942-4
Primary Topic
Neonatal Respiratory Health Research
Type
article
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article

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

D Quine, Harsha Gowda, C Dani, B Simma et al.
Pediatric Research
Neonatal Respiratory Health Research
article

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

D Quine, Harsha Gowda, C Dani, B Simma, Richard Hall, Sri Joshi, Francesca Orsini, Martijn Miedema, Wolfgang Stelzl, Haresh Kirpalani, Laura Galletta, Prakash Kannan Loganathan, Francesco Cavigioli, Ilia Bresesti, Sherry E. Courtney, P Davis, Camilla Rigotti, Arun Sett, De Luca, David Stewart, Joyce O’Shea, Hendrik Niemarkt, Elizabeth Foglia, Helen Liley, Xiaofang Wang, David G. Tingay, Michael Stark, Tomasz Szczapa, Gianluca Lista, for the POLAR Trial Investigators, Joseph Fawke, Louise S. Owen, Monique Fatmous, Anton H van Kaam, Willem de Boode, Giovanni Vento, Elizabeth Perkins, Bobbi Byrne, Charles C. Roehr, Omar Kamlin, Andrew Gill, Joanna Bezette, Anna Lavizzari, Karen McCall, Anup Katheria
article en

Abstract

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.

Pediatric Research
Università Cattolica del Sacro Cuore (IT), Poznan University of Medical Sciences (PL), North Bristol NHS Trust (GB), University Hospitals Birmingham NHS Foundation Trust (GB), NHS Lothian (GB), Royal Women's Hospital (AU), Children's Hospital of Philadelphia (US), Radboud University Nijmegen (NL), The University of Melbourne (AU), Université Paris-Saclay (FR), Leicester Royal Infirmary (GB), Royal Hospital for Children (GB), Ospedale Filippo Del Ponte Varese (IT), James Cook University Hospital (GB), Women's and Children's Hospital (AU), King Edward Memorial Hospital (AU), NHS Lanarkshire (GB), University Hospitals of Leicester NHS Trust (GB), Riley Hospital for Children (US), Radboud University Medical Center (NL), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), South Tees Hospitals NHS Foundation Trust (GB), University of Bristol (GB), University of Oxford (GB), Landeskrankenhaus Feldkirch (AT), Emma Kinderziekenhuis (NL), Assistance Publique – Hôpitaux de Paris (FR), Azienda Ospedaliera San Gerardo (IT), Parenting Research Centre (AU), Azienda Ospedaliero-Universitaria Careggi (IT), Indiana University Bloomington (US), Máxima Medisch Centrum (NL), Mater Mothers' Hospital (AU), Ospedale dei Bambini Vittore Buzzi (IT), Sharp Mary Birch Hospital for Women & Newborns (US), Hôpital Antoine-Béclère (FR), Murdoch Children's Research Institute (AU), Amsterdam University Medical Centers (NL), The University of Adelaide (AU), University of Arkansas for Medical Sciences (US)
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Neonatal Respiratory Health Research
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