Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial). (NCT04372953)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arkansas for Medical Sciences — Little Rock, Arkansas
Age range: 23 Weeks to 28 Weeks
🧪 Interventions in This Study
- Positive End-Expiratory Pressure (PEEP) (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (27 Sites)
Showing the first 25 of 27 sites.
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Sharp Mary Birch Hospital for Women & Newborns — San Diego, California
- Indiana University / Riley Children Health at Indiana University Health — Indianapolis, Indiana
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
- Mater Misericordiae — South Brisbane, Queensland
- Women & Childrens Hospital Adelaide — Adelaide, South Australia
- Joan Kirner Women & Children's Hospital - VIC — Melbourne, Victoria
- The Royal Women's Hospital, Melbourne Australia — Parkville, Victoria
- King Edward Memorial Hospital — Subiaco, Western Australia
- Academic Teaching Hospital — Feldkirch,
- Antoine Beclere Medical Center / South Paris University Hospitals — Paris,
- San Gerardo Hospital — Monza, Milan
- Filippo del Ponte Hospital — Varese, Milan
- Careggi Hospital — Florence,
- Ospedale Maggiore Policlinico — Milan,
- Vittore Buzzi Children's Hospital / Ospedale dei Bambini — Milan,
- Gemelli University Hospital — Rome,
- Amsterdam University Medical Centre — Amsterdam,
- Amalia Children's Hospital Radboudumc — Nijmegen,
- Maxima Medical Centre — Veldhoven,
- Birmingham Heartlands Hospital — Birmingham, England
- Southmead Hospital — Bristol, England
- James Cook University Hospital — Middlesbrough, England
- Royal Infirmary Edinburgh — Edinburgh, Scotland
- Royal Hospital for Children — Glasgow, Scotland
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.