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ACTIVE NOT RECRUITING
NCT04372953
NA

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

Sponsor: Murdoch Childrens Research Institute

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

23 Weeks - 28 Weeks

Study Type

INTERVENTIONAL

Enrollment

906

Start Date

2021-05-04

Completion Date

2028-05-30

Last Updated

2026-02-19

Healthy Volunteers

No

Interventions

PROCEDURE

Positive End-Expiratory Pressure (PEEP)

PEEP is the delivery of any level of positive pressure to the lungs during expiration, by any method of assisted respiratory support. As the intervention in the Delivery Room PEEP will be administered via any of: 1. Continuous Positive Applied Pressure (CPAP; non-invasive respiratory support) During CPAP, no other type of positive pressure is delivered as the infant supports tidal ventilation using her/his own spontaneous breathing effort. 2. Positive Pressure Ventilation (PPV) During PPV, PEEP is delivered between periods of an applied inflating pressure (PIP) delivered at a clinician-determined rate. PPV can be delivered via a mask or other non-invasive interface (also termed non-invasive positive pressure ventilation; NIPPV), or via an endotracheal tube (often termed continuous mechanical ventilation; CMV).

Locations (27)

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

University Hospital Wishaw

Wishaw, Scotland, United Kingdom

University Hospitals Leicester

Leicester, United Kingdom