Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).
POLAR
1 other identifier
interventional
906
6 countries
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2020
CompletedFirst Posted
Study publicly available on registry
May 4, 2020
CompletedStudy Start
First participant enrolled
May 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2028
February 19, 2026
February 1, 2026
5.6 years
April 27, 2020
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The prevalence of the composite outcome of either death or bronchopulmonary dysplasia (BPD), as assessed by standard oxygen reduction test.
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.
At 36 weeks post menstrual age.
Secondary Outcomes (23)
The rate/incidence of failure of non-invasive ventilation in first 72 hours, as assessed by intubation status.
From the time of birth until 72 hours post birth.
The rate/incidence of death within the first 10 days of life, as assessed by date of death.
From the time of birth until 10 days post birth.
Oxygen requirement ≥50% for 3 or more consecutive hours in first 72 hours
From the time of birth until 72 hours post birth.
Supplementary oxygen use
From the time of birth until 10 days of age.
The rate/incidence of surfactant therapy requirement within the first 72 hours of life, as assessed by surfactant therapy status.
From the time of birth until 72 hours post birth.
- +18 more secondary outcomes
Study Arms (2)
Static PEEP Group
ACTIVE COMPARATORDelivery 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.
Dynamic PEEP Group
EXPERIMENTALDynamic 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.
Interventions
PEEP is the delivery of any level of positive pressure to the lungs during expiration, by any method of assisted respiratory support. As the intervention in the Delivery Room PEEP will be administered via any of: 1. Continuous Positive Applied Pressure (CPAP; non-invasive respiratory support) During CPAP, no other type of positive pressure is delivered as the infant supports tidal ventilation using her/his own spontaneous breathing effort. 2. Positive Pressure Ventilation (PPV) During PPV, PEEP is delivered between periods of an applied inflating pressure (PIP) delivered at a clinician-determined rate. PPV can be delivered via a mask or other non-invasive interface (also termed non-invasive positive pressure ventilation; NIPPV), or via an endotracheal tube (often termed continuous mechanical ventilation; CMV).
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Murdoch Childrens Research Institutelead
- University of Pennsylvaniacollaborator
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)collaborator
- University of Oxfordcollaborator
Study Sites (27)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123, 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
Mater Misericordiae
South Brisbane, Queensland, 4101, Australia
Women & Childrens Hospital Adelaide
Adelaide, South Australia, Australia
Joan Kirner Women & Children's Hospital - VIC
Melbourne, Victoria, 3021, Australia
The Royal Women's Hospital, Melbourne Australia
Parkville, Victoria, 3052, Australia
King Edward Memorial Hospital
Subiaco, Western Australia, 6008, Australia
Academic Teaching Hospital
Feldkirch, 6800, Austria
Antoine Beclere Medical Center / South Paris University Hospitals
Paris, France
San Gerardo Hospital
Monza, Milan, 20090, Italy
Filippo del Ponte Hospital
Varese, Milan, 21100, Italy
Careggi Hospital
Florence, Italy
Ospedale Maggiore Policlinico
Milan, Italy
Vittore Buzzi Children's Hospital / Ospedale dei Bambini
Milan, Italy
Gemelli University Hospital
Rome, Italy
Amsterdam University Medical Centre
Amsterdam, 1105, Netherlands
Amalia Children's Hospital Radboudumc
Nijmegen, 6500, Netherlands
Maxima Medical Centre
Veldhoven, 5504, Netherlands
Birmingham Heartlands Hospital
Birmingham, England, B9 5SS, United Kingdom
Southmead Hospital
Bristol, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Royal Infirmary Edinburgh
Edinburgh, Scotland, EH16 4SA, United Kingdom
Royal Hospital for Children
Glasgow, Scotland, United Kingdom
University Hospital Wishaw
Wishaw, Scotland, United Kingdom
University Hospitals Leicester
Leicester, United Kingdom
Related Publications (1)
Jensen EA, Dysart K, Gantz MG, McDonald S, Bamat NA, Keszler M, Kirpalani H, Laughon MM, Poindexter BB, Duncan AF, Yoder BA, Eichenwald EC, DeMauro SB. The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach. Am J Respir Crit Care Med. 2019 Sep 15;200(6):751-759. doi: 10.1164/rccm.201812-2348OC.
PMID: 30995069BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Tingay, MBBS FRACP
Royal Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The clinical team within the Delivery Room managing enrolled and randomised infants will not be masked/blinded to the intervention. Members of the Research Team at participating sites will also not be masked/blinded to the intervention. Research staff based at the central Trial Coordinating Centre (TCC), the Data Coordinating Centre (DCCe) and the Trial Statistician will be blinded to assigned treatment.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2020
First Posted
May 4, 2020
Study Start
May 4, 2021
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
May 30, 2028
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 6 months after publication of primary outcome.
- Access Criteria
- Prior to releasing any data the following are required: 1. A Data Transfer Agreement must be signed between relevant parties. 2. The MCRI Sponsorship Committee must review and approve your protocol and statistical analysis plan which must include and describe how the data will be used and analysed. 3. An Authorship Agreement to be agreed to and signed between relevant parties. The Agreement must include details regarding appropriate recognition. Authorship may not be justifiable but some form of acknowledgement is requested. 4. Agreement to cover any additional costs relating to the provision of the data. 5. Evidence of ethics approval or waiver of approval, to be compliant with the data transfer agreement and ethics requirements at our end. Data will only be shared with a recognised research institution where the MCRI Sponsorship Committee has approved the proposed analysis plan.
The de-identified data set collected for this analysis of the POLAR trial will be available six months after publication of the primary outcome. The study protocol, statistical analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing david.tingay@rch.org.au and mctc@mcri.edu.au.