RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-05-04
Study Completion:2028-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04372953

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:23 Weeks to 28 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Infants born between 23 weeks 0 days and 28 weeks 6 days PMA (by best obstetric estimate).
  2. * 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.
  3. * 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).
  1. * Not for active care based on assessment of the attending clinician or family decision
  2. * Anticipated severe pulmonary hypoplasia due to rupture of membranes \<22 weeks with anhydramnios or fetal hydrops
  3. * Major congenital anomaly or anticipated alternative cause for respiratory failure
  4. * Refusal of informed consent by their legally acceptable representative
  5. * Does not have a guardian who can provide informed consent.

Contacts and Locations

Study Contact

David Tingay, MBBS FRACP
CONTACT
+61 3 9345 4023
david.tingay@rch.org.au
Laura Galletta, BSc
CONTACT
+61 3 9936 6448
laura.galletta@mcri.edu.au

Principal Investigator

David Tingay, MBBS FRACP
PRINCIPAL_INVESTIGATOR
Royal Children's Hospital, Melbourne, Australia

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Rady Children's at Scripps Memorial Hospital La Jolla/UCSD
San Diego, California, 92037
United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
United States
Rady Children's at Rancho Springs Medical Center/UCSD
San Diego, California, 92562
United States
Indiana University / Riley Children Health at Indiana University Health
Indianapolis, Indiana, 46202
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Murdoch Childrens Research Institute

  • David Tingay, MBBS FRACP, PRINCIPAL_INVESTIGATOR, Royal Children's Hospital, Melbourne, Australia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-04
Study Completion Date2028-05-30

Study Record Updates

Study Start Date2021-05-04
Study Completion Date2028-05-30

Terms related to this study

Keywords Provided by Researchers

  • Resuscitation
  • Positive End-Expiratory Pressure (PEEP)
  • Bronchopulmonary Dysplasia

Additional Relevant MeSH Terms

  • Lung Injury
  • Preterm Birth