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PEEP Levels for Premature Birth (POLAR Trial)

N/A

Recruiting

Led By Louise Owen

Research Sponsored by Murdoch Childrens Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Infants born between 23 weeks 0 days and 28 weeks 6 days PMA (by best obstetric estimate)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of birth through transfer to nicu (within two hours from birth)

Awards & highlights

POLAR Trial Summary

This trial is testing two different ways of giving a baby air after it's born prematurely, to see which is better.

Who is the study for?

The POLAR trial is for very premature infants born between 23 and 28 weeks who need help breathing at birth. It's not for babies with severe lung problems, major birth defects, or those whose families decide against aggressive care.Check my eligibility

What is being tested?

This study tests two ways of using PEEP in resuscitation: a constant level versus starting high then lowering it. The goal is to see which method better prevents lung collapse without increasing the risk of chronic lung disease.See study design

What are the potential side effects?

PEEP can cause side effects like overinflating the lungs (barotrauma), affecting blood circulation, or causing air leaks around the lungs. However, these are monitored closely during treatment.

POLAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My newborn needed breathing support right after birth due to being premature.

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My baby was born between 23 and 28 weeks of pregnancy.

POLAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours of age.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours of age.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours of age. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The prevalence of the composite outcome of either death or bronchopulmonary dysplasia (BPD), as assessed by standard oxygen reduction test.

Secondary outcome measures

Airleak

Duration of respiratory support

Highest PEEP used during non-invasive ventilation

+20 more

POLAR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dynamic PEEP GroupExperimental Treatment1 Intervention

Dynamic delivery of PEEP at 8 cmH2O via a T-piece resuscitator using an initial fraction of inspired oxygen (FiO2) of 0.30 via local standard interface (facemask, nasopharyngeal tube or nasal prong). PEEP levels increased step-wise to 10 and/or 12 cmH2O if FiO2/respiratory care needs to be escalated as per a standardised resuscitation algorithm. If an infant shows evidence of respiratory improvement during resuscitative care, PEEP will be reduced in a stepwise method by 2 cmH2O each reduction, but to no lower than 8 cmH2O.

Group II: Static PEEP GroupActive Control1 Intervention

Delivery of PEEP at 5-6 cmH2O via a T-piece resuscitator using an initial fraction of inspired oxygen (FiO2) of 0.30 via local standard interface (facemask, nasopharyngeal tube or nasal prong). FiO2 and other aspects of respiratory care are then titrated using a standardised resuscitation algorithm.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER

2,005 Previous Clinical Trials

42,881,303 Total Patients Enrolled

22 Trials studying Premature Birth

11,176 Patients Enrolled for Premature Birth

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)OTHER

664 Previous Clinical Trials

2,675,979 Total Patients Enrolled

9 Trials studying Premature Birth

2,072,580 Patients Enrolled for Premature Birth

University of OxfordOTHER

1,055 Previous Clinical Trials

16,201,640 Total Patients Enrolled

10 Trials studying Premature Birth

5,641 Patients Enrolled for Premature Birth

Media Library

Positive End-Expiratory Pressure (PEEP) Clinical Trial Eligibility Overview. Trial Name: NCT04372953 — N/A

Premature Birth Research Study Groups: Dynamic PEEP Group, Static PEEP Group

Premature Birth Clinical Trial 2023: Positive End-Expiratory Pressure (PEEP) Highlights & Side Effects. Trial Name: NCT04372953 — N/A

Positive End-Expiratory Pressure (PEEP) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04372953 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current cap in terms of participants for this experiment?

"Affirmative, the trial's listing on clinicaltrials.gov confirms that it is actively recruiting patients; its first posting was on May 4th 2021 and there has been an update as recent as November 22nd 2022. This research project requires 906 participants to be enrolled from 3 distinct sites."

Answered by AI

Is this experiment open to new volunteers?

"Confirmed. According to clinicaltrials.gov, this experiment which was initially published on May 4th 2021 is still in the process of recruiting participants with 906 needed from 3 separate sites."

Answered by AI

Recent research and studies

American Journal of Respiratory and Critical Care MedicineJournal

The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach

Jensen, Erik A., Kevin Dysart, Marie G. Gantz, Scott McDonald, Nicolas A. Bamat, Martin Keszler, Haresh Kirpalani, et al.. 2019. “The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.201812-2348oc.

American Journal of Respiratory and Critical Care MedicineJournal

The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach

clinicaltrials.govStudy

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

2021. "Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04372953.