Status:
RECRUITING
Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).
Lead Sponsor:
Murdoch Childrens Research Institute
Collaborating Sponsors:
University of Pennsylvania
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Lung Injury
Preterm Birth
Eligibility:
All Genders
23-28 years
Phase:
NA
Brief 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-develo...
Detailed Description
All infants born \<29 weeks' postmenstrual age (PMA) require positive end-expiratory pressure (PEEP) at birth. PEEP is a simple, feasible and cost-effective therapy to support extremely preterm infant...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2028
Estimated Enrollment :
906 Patients enrolled
Trial Details
Trial ID
NCT04372953
Start Date
May 4 2021
End Date
May 30 2028
Last Update
September 9 2025
Active Locations (28)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States, 92123
3
Indiana University / Riley Children Health at Indiana University Health
Indianapolis, Indiana, United States, 46202
4
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104