Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).
NCT ID: NCT04372953
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
906 participants
INTERVENTIONAL
2021-05-04
2028-05-30
Brief Summary
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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.
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Detailed Description
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The Investigators will undertake an international multi-centre randomised controlled trial to address in extremely preterm infants, whether the use of a high, dynamic PEEP level strategy to support the lung during stabilisation ('resuscitation') at birth, compared to the current practice of a static PEEP level, will reduce the rate of death or bronchopulmonary dysplasia (BPD).
This trial will address the following four key knowledge gaps:
1. Assessing whether individualising (dynamic) PEEP is superior to static PEEP
2. The uncertainty regarding applied pressure strategies to support the lung during stabilisation at birth arising from the lack of a properly powered, well-designed randomised trial specifically addressing important outcomes for respiratory support in the Delivery Room
3. The optimal PEEP strategy to use
4. Determining the differential effects of PEEP at different gestational ages.
For this study, the term PEEP refers to the delivery of positive pressure (via a bias flow of gas) to the lungs during expiration by any method of assisted respiratory support, this includes:
1. Continuous Positive Applied Pressure (CPAP; a method of 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. PEEP during CPAP has also been called 'continuous distending pressure.
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).
3. High-frequency oscillatory ventilation (HFOV) or high-frequency jet ventilation. These are modes of invasive PPV in which PIP is delivered at very fast rates (\>120 inflations per minute) and at very small tidal volumes. During HFOV a mean airway pressure is determined by the clinician which is equivalent to the PEEP during other modes. During high-frequency jet ventilation the clinician sets a PEEP similar to CMV.
As all of these modes of ventilation have a similar goal of applying a pressure to the lung during expiration (usually to prevent lung collapse) the term PEEP has the same physiological result despite different methods of application.
The specific aim of the trial is to establish whether the use of a high, dynamic 8-12 cmH2O PEEP level ('dynamic') strategy to support the lung during stabilisation at birth, compared with a static 5-6 cmH2O PEEP level ('static') strategy, increases the rate of survival without bronchopulmonary dysplasia (BPD) in extremely preterm infants born \<29 weeks' PMA, and reduces rates of common neonatal morbidities.
The Investigators hypothesise that in preterm infants born \<29 weeks PMA who receive respiratory support during stabilisation at birth, a high, dynamic PEEP strategy (i.e. PEEP 8-12 cmH2O individualised to clinical need) as compared to a standard, static PEEP of 5-6 cmH2O, will:
1. Increase survival without BPD (primary outcome); and
2. Reduce rates of common neonatal morbidities such as failure of non-invasive respiratory support in the first 72 hours of life (secondary outcome).
This trial is a phase III/IV, two parallel group, non-blinded, 1:1 randomised controlled, multi-national, multi-centre study comparing dynamic PEEP (dynamic group) with standard PEEP strategy (static group).
The intervention will take place in the Delivery Room. The intervention period will be from the time of birth until 20 minutes of life or transfer from Delivery Room to NICU (whatever comes first). The follow-up period will extend to 36 weeks PMA (primary endpoint), and 24 months corrected GA to determine important long-term neurodevelopmental and respiratory outcomes.
The clinical team within the Delivery Room managing enrolled and randomised infants will not be masked/blinded to the intervention. Clinicians need to be able to see the PEEP delivery device to assess efficacy of pressure delivery. The Research Coordinator/Study team at site will also not be masked/blinded to the intervention, as they will be entering trial data into the data management system.
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.
There will be a total of 906 infants recruited (453 in the Dynamic group, 453 in the Static group), over 25 recruitment centres across Australia, Europe, the United Kingdom, the Middle East, Canada and North America.
The study will have Regional Coordinating Centres (RCCs) established in the following jurisdictions:
1. Australia - The Murdoch Children's Research Institute/Royal Women's Hospital, Melbourne, AUS
2. The Netherlands - Amsterdam University Medical Centre, Netherlands, EU
3. The United Kingdom - The University of Oxford / National Perinatal Epidemiology Unit (NPEU), Oxford, UK, and
4. North America - the Hospital of the University of Pennsylvania, Pennsylvania, USA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
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.
Study Groups
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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.
Positive End-Expiratory Pressure (PEEP)
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).
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.
Positive End-Expiratory Pressure (PEEP)
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).
Interventions
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Positive End-Expiratory Pressure (PEEP)
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
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
23 Weeks
28 Weeks
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
University of Oxford
OTHER
Murdoch Childrens Research Institute
OTHER
Responsible Party
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Principal Investigators
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David Tingay, MBBS FRACP
Role: PRINCIPAL_INVESTIGATOR
Royal Children's Hospital
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
Indiana University / Riley Children Health at Indiana University Health
Indianapolis, Indiana, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Mater Misericordiae
South Brisbane, Queensland, Australia
Women & Childrens Hospital Adelaide
Adelaide, South Australia, Australia
Joan Kirner Women & Children's Hospital - VIC
Melbourne, Victoria, Australia
The Royal Women's Hospital, Melbourne Australia
Parkville, Victoria, Australia
King Edward Memorial Hospital
Subiaco, Western Australia, Australia
Academic Teaching Hospital
Feldkirch, Feldkirch, Austria
Antoine Beclere Medical Center / South Paris University Hospitals
Paris, Paris, France
Careggi Hospital
Florence, Florence, Italy
Ospedale Maggiore Policlinico
Milan, Milan, Italy
Vittore Buzzi Children's Hospital / Ospedale dei Bambini
Milan, Milan, Italy
San Gerardo Hospital
Monza, Milan, Italy
Filippo del Ponte Hospital
Varese, Milan, Italy
Gemelli University Hospital
Rome, Rome, Italy
Amsterdam University Medical Centre
Amsterdam, Amsterdam, Netherlands
Amalia Children's Hospital Radboudumc
Nijmegen, Nijmegen, Netherlands
Maxima Medical Centre
Veldhoven, Veldhoven, Netherlands
Poznan University of Medical Sciences
Poznan, Poznan, Poland
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Southmead Hospital
Bristol, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Royal Infirmary Edinburgh
Edinburgh, Scotland, United Kingdom
Royal Hospital for Children
Glasgow, Scotland, United Kingdom
University Hospital Wishaw
Wishaw, Scotland, United Kingdom
University Hospitals Leicester
Leicester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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POLAR #60303
Identifier Type: -
Identifier Source: org_study_id
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