The POLAR Trial
Research type
Research Study
Full title
The Positive End-Expiratory Pressure Levels during Resuscitation of Preterm Infants at Birth Trial
IRAS ID
305231
Contact name
David Tingay
Contact email
Sponsor organisation
Murdoch Children's Research Institute
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ACTRN12618001686291, Australia and New Zealand Clinical Trials Registry (ANZCTR) Registry
Duration of Study in the UK
6 years, 6 months, 30 days
Research summary
All premature babies born less than 29 weeks postmenstrual age (PMA) require positive end-expiratory pressure (PEEP) at birth. PEEP is a therapy whereby positive pressure in the baby's lungs is maintained during the end of each breath. In preterm babies the pressure in the lungs at the end of each breath is lower than that of the pressure outside of the body therefore PEEP will assist the lungs by staying inflated enough to help the baby breath. The effective and safe level of PEEP to use after preterm birth remains undetermined. The POLAR Trial will address the following question: in extremely preterm infants, does the use of a high, dynamic PEEP level strategy (babies given a higher level of PEEP with the level adjusted up or down in response to babies needs) to support the lung during stabilization (‘resuscitation’) at birth, compared with the current practice of a static PEEP level (the same level amount of PEEP without adjustment), reduce the rate of death or bronchopulmonary dysplasia (BPD)? All other aspects of clinical care in the delivery room and NICU will be the same. The trial will be recruiting across 25 hospitals in Australia, Europe, the UK and the USA. The trial is funded by the Medical Research Future Fund (Australian Government) International Clinical Trials Collaborations Grant and the Murdoch Children's Research Institute (Australia). Eligible babies are those born prematurely between 23 weeks 0 days and 28 weeks and 6 days in participating study centres and who require respiratory intervention from birth. The trial will recruit 906 infants (453 to static PEEP and 453 to dynamic PEEP) with the intervention given in the Delivery Room (DR) of the NICU. Infants will be followed-up at 24 months of age to assess their neurological and respiratory development and outcomes.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
21/SW/0147
Date of REC Opinion
3 Dec 2021
REC opinion
Further Information Favourable Opinion