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

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 6 months
Healthy Volunteers: f
View:

• 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).

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
California
Sharp Mary Birch Hospital for Women & Newborns
RECRUITING
San Diego
Indiana
Indiana University / Riley Children Health at Indiana University Health
RECRUITING
Indianapolis
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Other Locations
Australia
Women & Childrens Hospital Adelaide
RECRUITING
Adelaide
Joan Kirner Women & Children's Hospital - VIC
RECRUITING
Melbourne
The Royal Women's Hospital, Melbourne Australia
RECRUITING
Parkville
Mater Misericordiae
RECRUITING
South Brisbane
King Edward Memorial Hospital
RECRUITING
Subiaco
Austria
Academic Teaching Hospital
RECRUITING
Feldkirch
France
Antoine Beclere Medical Center / South Paris University Hospitals
RECRUITING
Paris
Italy
Careggi Hospital
RECRUITING
Florence
Ospedale Maggiore Policlinico
RECRUITING
Milan
Vittore Buzzi Children's Hospital / Ospedale dei Bambini
RECRUITING
Milan
San Gerardo Hospital
RECRUITING
Monza
Gemelli University Hospital
RECRUITING
Rome
Filippo del Ponte Hospital
RECRUITING
Varese
Netherlands
Amsterdam University Medical Centre
ACTIVE_NOT_RECRUITING
Amsterdam
Amalia Children's Hospital Radboudumc
RECRUITING
Nijmegen
Maxima Medical Centre
RECRUITING
Veldhoven
Poland
Poznan University of Medical Sciences
WITHDRAWN
Poznan
United Kingdom
Birmingham Heartlands Hospital
RECRUITING
Birmingham
Southmead Hospital
RECRUITING
Bristol
Royal Infirmary Edinburgh
NOT_YET_RECRUITING
Edinburgh
Royal Hospital for Children
RECRUITING
Glasgow
University Hospitals Leicester
RECRUITING
Leicester
James Cook University Hospital
RECRUITING
Middlesbrough
University Hospital Wishaw
RECRUITING
Wishaw
Contact Information
Primary
David Tingay, MBBS FRACP
david.tingay@rch.org.au
+61 3 9345 4023
Backup
Laura Galletta, BSc
laura.galletta@mcri.edu.au
+61 3 9936 6448
Time Frame
Start Date: 2021-05-04
Estimated Completion Date: 2028-05-30
Participants
Target number of participants: 906
Treatments
Active_comparator: Static PEEP Group
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.
Experimental: Dynamic PEEP Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Oxford, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Pennsylvania
Leads: Murdoch Childrens Research Institute

This content was sourced from clinicaltrials.gov