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Testing different PEEP levels for premature infants at birth

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

NA · Murdoch Childrens Research Institute · NCT04372953

This study is testing whether using a new breathing support method for very premature babies at birth can help them breathe better and reduce serious lung problems compared to the usual method.

Quick facts

PhaseNA
Study typeInterventional
Enrollment906 (estimated)
Ages23 Weeks to 28 Weeks
SexAll
SponsorMurdoch Childrens Research Institute (other)
Locations30 sites (Little Rock, Arkansas and 29 other locations)
Trial IDNCT04372953 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of two different approaches to positive end-expiratory pressure (PEEP) during the resuscitation of extremely preterm infants born before 29 weeks of gestation. The study aims to determine whether a high, dynamic PEEP strategy is superior to the current static PEEP practice in reducing the rates of death or bronchopulmonary dysplasia (BPD). Conducted as an international multi-centre randomized controlled trial, it seeks to address key knowledge gaps in neonatal respiratory medicine regarding optimal PEEP strategies. The trial will involve infants receiving respiratory support at birth and will assess outcomes related to lung stabilization.

Who should consider this trial

Good fit: Ideal candidates are infants born between 23 weeks 0 days and 28 weeks 6 days postmenstrual age requiring respiratory support at birth.

Not a fit: Patients not receiving active care or those with severe congenital anomalies or conditions leading to anticipated respiratory failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and reduced incidence of lung injury in extremely preterm infants.

How similar studies have performed: Other studies have explored PEEP strategies, but this trial aims to provide robust evidence specifically for extremely preterm infants, making it a significant advancement in the field.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Little Rock, Arkansas and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Lung Injury, Preterm Birth, Resuscitation, Positive End-Expiratory Pressure, Bronchopulmonary Dysplasia

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.