Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).

Running, not enrolling · Not applicable

Conditions studied: Lung Injury, Preterm Birth

In brief

Premature babies often need help immediately after birth to open their lungs to air, start breathing and keep their hearts beating. Opening their lungs can be difficult, and once open the under-developed lungs of premature babies will often collapse again between each breath. To prevent this nearly all premature babies receive some form of mechanical respiratory support to aid breathing. Common to all types of respiratory support is the delivery of a treatment called positive end-expiratory pressure, or PEEP. PEEP gives air, or a mixture of air and oxygen, to the lung between each breath to keep the lungs open and stop them collapsing. Currently, clinicians do not have enough evidence on the right amount, or level, of PEEP to give at birth. As a result, doctors around the world give different amounts (or levels) of PEEP to premature babies at birth. In this study, the Investigators will look at 2 different approaches to PEEP to help premature babies during their first breaths at birth. At the moment, the Investigators do not know if one is better than the other. One is to give the same PEEP level to the lungs. The others is to give a high PEEP level at birth when the lungs are hardest to open and then decrease the PEEP later once the lungs are opened and the baby is breathing. Very premature babies have a risk of long-term lung disease (chronic lung disease). The more breathing support a premature baby needs, the more likely the risk of developing chronic lung disease. The Investigators want to find out whether one method of opening the baby's lungs at birth results in them needing less breathing support. This research has been initiated by a group of doctors from Australia, the Netherlands and the USA, all who look after premature babies.

Key facts

Study ID

NCT04372953

Run by

Murdoch Childrens Research Institute

People needed

906

Starts

2021-05-04

Expected to finish

2028-05-30

Last updated by the study team

2026-02-19

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants born between 23 weeks 0 days and 28 weeks 6 days PMA (by best obstetric estimate).
• Receives respiratory intervention (resuscitation) at birth with CPAP and/or positive pressure ventilation in the Delivery Room, to support transition and/or respiratory failure related to prematurity.
• Has a parent or other legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf either prospectively or after birth and randomisation if prenatal consent was not possible (at sites where the Ethics Committee permits waiver of prospective consent).

You may not qualify if…

• Not for active care based on assessment of the attending clinician or family decision
• Anticipated severe pulmonary hypoplasia due to rupture of membranes <22 weeks with anhydramnios or fetal hydrops
• Major congenital anomaly or anticipated alternative cause for respiratory failure
• Refusal of informed consent by their legally acceptable representative
• Does not have a guardian who can provide informed consent.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States
• Indiana University / Riley Children Health at Indiana University Health — Indianapolis, Indiana, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Mater Misericordiae — South Brisbane, Queensland, Australia
• Women & Childrens Hospital Adelaide — Adelaide, South Australia, Australia
• Joan Kirner Women & Children's Hospital - VIC — Melbourne, Victoria, Australia
• The Royal Women's Hospital, Melbourne Australia — Parkville, Victoria, Australia
• King Edward Memorial Hospital — Subiaco, Western Australia, Australia
• Academic Teaching Hospital — Feldkirch, Austria
• Antoine Beclere Medical Center / South Paris University Hospitals — Paris, France
• San Gerardo Hospital — Monza, Milan, Italy
• Filippo del Ponte Hospital — Varese, Milan, Italy
• Careggi Hospital — Florence, Italy
• Ospedale Maggiore Policlinico — Milan, Italy
• Vittore Buzzi Children's Hospital / Ospedale dei Bambini — Milan, Italy
• Gemelli University Hospital — Rome, Italy
• Amsterdam University Medical Centre — Amsterdam, Netherlands
• Amalia Children's Hospital Radboudumc — Nijmegen, Netherlands
• Maxima Medical Centre — Veldhoven, Netherlands
• Birmingham Heartlands Hospital — Birmingham, England, United Kingdom
• Southmead Hospital — Bristol, England, United Kingdom
• James Cook University Hospital — Middlesbrough, England, United Kingdom
• Royal Infirmary Edinburgh — Edinburgh, Scotland, United Kingdom
• Royal Hospital for Children — Glasgow, Scotland, United Kingdom

Full record on ClinicalTrials.gov

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