Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04372953 · ClinicalTrials.gov registry record · NA

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

A NA study of Preterm Birth and Lung Injury, sponsored by Murdoch Childrens Research Institute.

Active
Registry status
NA
Development phase
906
Enrollment target
20
Study locations

NCT04372953: Active NA study of Preterm Birth and Lung Injury, sponsored by Murdoch Childrens Research Institute.

NCT04372953 is a NA study of Preterm Birth and Lung Injury that is active but no longer recruiting, run by Murdoch Childrens Research Institute. The registered enrollment target is 906 participants, below the 4,386-participant average among 39 other Preterm Birth trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04372953, a NA study of Preterm Birth and Lung Injury, is active but no longer recruiting, sponsored by Murdoch Childrens Research Institute.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
906 participants
Enrollment target
20
Study locations

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.

Primary Outcome

This is defined as the proportion of participants in the analysis set with a confirmed death date or a diagnosis of bronchopulmonary dysplasia (BPD), at 36 weeks post menstrual age.

Conditions Studied

Preterm Birth Lung Injury

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

FieldValue
Enrollment Target 906 participants
Start Date 2021-05-04
Est. Completion 2028-05-30
Phase NA
Murdoch Childrens Research Institute

4 total trials

What the registry record for NCT04372953 still lists

NCT04372953 is an interventional study that assigns participants to a tested intervention. The registered 906 participants enrollment target is mid-sized for trials with a published cap, below the 4,386-participant average among 39 other Preterm Birth trials with a reported enrollment target (79% lower).

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.

NCT04372953 names 20 study sites across 10 states, led by Other, Victoria, Milan.

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.

What interventions are being tested in trial NCT04372953?

The interventions under investigation include: Positive End-Expiratory Pressure (PEEP) (PROCEDURE).

Who is sponsoring clinical trial NCT04372953?

This trial is sponsored by Murdoch Childrens Research Institute, which has 4 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Preterm Birth

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04372953's enrollment target sits among peer trials

906 10th of 39 higher than 30 of 39 other Preterm Birth trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Preterm Birth trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT05658497 · 908 participants

    Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

  • NCT06216548 · 909 participants · NA

    E-PRIME For Children With Medical Complexity

  • NCT05769777 · 901 participants · Phase 2

    Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

  • NCT02352116 · 900 participants · NA

    Evaluation of Post-PACU Pain Management in Pediatric Surgery

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT04372953, the US trial registry maintained by the National Library of Medicine. NCT04372953 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.