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Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).
Sponsor: Murdoch Childrens Research Institute
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
Conditions
Interventions
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