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Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).
NCT04372953 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Positive End-Expiratory Pressure (PEEP)
Study Locations (20)
Other
- Academic Teaching Hospital — Feldkirch
- Antoine Beclere Medical Center / South Paris University Hospitals — Paris
- 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
Victoria
- Joan Kirner Women & Children's Hospital - VIC — Melbourne
- The Royal Women's Hospital, Melbourne Australia — Parkville
Milan
- San Gerardo Hospital — Monza
- Filippo del Ponte Hospital — Varese
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
California
- Sharp Mary Birch Hospital for Women & Newborns — San Diego
Indiana
- Indiana University / Riley Children Health at Indiana University Health — Indianapolis
Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia
Queensland
- Mater Misericordiae — South Brisbane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 906 participants |
| Start Date | 2021-05-04 |
| Est. Completion | 2028-05-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04372953
The ClinicalTrials.gov registry entry for NCT04372953 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 906 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Murdoch Childrens Research Institute, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Preterm Birth appearing as the primary indexed condition, and to 1 intervention — of which Positive End-Expiratory Pressure (PEEP) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04372953 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Victoria, Milan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04372953 about?
NCT04372953 is a clinical study titled "Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).". 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 ...
What is the current status of trial NCT04372953?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 906 participants. The study started on 2021-05-04. Estimated completion is 2028-05-30.
What conditions does trial NCT04372953 study?
This clinical trial studies the following conditions: Preterm Birth, Lung Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04372953?
The interventions under investigation include: Positive End-Expiratory Pressure (PEEP) (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04372953?
This trial is sponsored by Murdoch Childrens Research Institute, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04372953 being conducted?
This trial has 20 study locations across Arkansas, California, Indiana, Pennsylvania, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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