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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04372953




Registration number
NCT04372953
Ethics application status
Date submitted
27/04/2020
Date registered
4/05/2020

Titles & IDs
Public title
Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).
Scientific title
Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).
Secondary ID [1] 0 0
POLAR #60303
Universal Trial Number (UTN)
Trial acronym
POLAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Injury 0 0
Preterm Birth 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Positive End-Expiratory Pressure (PEEP)

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.


Treatment: Surgery: 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).
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The prevalence of the composite outcome of either death or bronchopulmonary dysplasia (BPD), as assessed by standard oxygen reduction test.
Timepoint [1] 0 0
At 36 weeks post menstrual age.
Secondary outcome [1] 0 0
The rate/incidence of failure of non-invasive ventilation in first 72 hours, as assessed by intubation status.
Timepoint [1] 0 0
From the time of birth until 72 hours post birth.
Secondary outcome [2] 0 0
The rate/incidence of death within the first 10 days of life, as assessed by date of death.
Timepoint [2] 0 0
From the time of birth until 10 days post birth.
Secondary outcome [3] 0 0
Oxygen requirement =50% for 3 or more consecutive hours in first 72 hours
Timepoint [3] 0 0
From the time of birth until 72 hours post birth.
Secondary outcome [4] 0 0
Supplementary oxygen use
Timepoint [4] 0 0
From the time of birth until 10 days of age.
Secondary outcome [5] 0 0
The rate/incidence of surfactant therapy requirement within the first 72 hours of life, as assessed by surfactant therapy status.
Timepoint [5] 0 0
From the time of birth until 72 hours post birth.
Secondary outcome [6] 0 0
The rate/incidence of grade 3 and 4 intraventricular haemorrhage within the first 72 hours of life, as defined via imaging.
Timepoint [6] 0 0
From the time of birth until 72 hours post birth.
Secondary outcome [7] 0 0
The rate/incidence of treatment failure within the delivery room, as assessed by intubation status.
Timepoint [7] 0 0
From the time of birth through transfer to NICU (within two hours from birth)
Secondary outcome [8] 0 0
The grade of bronchopulmonary dysplasia (BPD), based on the results of an oxygen reduction test.
Timepoint [8] 0 0
At 36 weeks post menstrual age.
Secondary outcome [9] 0 0
Incidence of Death at 36 week PMA
Timepoint [9] 0 0
At 36 weeks post menstrual age.
Secondary outcome [10] 0 0
Incidence of Bronchopulmonary dysplasia (BPD) at 36 week PMA
Timepoint [10] 0 0
At 36 weeks post menstrual age.
Secondary outcome [11] 0 0
Incidence of air leak and/or pulmonary interstitial emphysema (defined on chest radiograph; CXR) in the first 10 days after birth
Timepoint [11] 0 0
Birth to 10 days of age.
Secondary outcome [12] 0 0
Airleak
Timepoint [12] 0 0
During hospital stay, on average until 36 weeks PMA.
Secondary outcome [13] 0 0
Retinopathy of prematurity (stage 3 or higher or requiring treatment)
Timepoint [13] 0 0
36-week corrected PMA.
Secondary outcome [14] 0 0
Significant brain injury (IVH grade 3 or 4, periventricular leukomalacia)
Timepoint [14] 0 0
36-week corrected PMA.
Secondary outcome [15] 0 0
Invasive ventilation at day 10 of age
Timepoint [15] 0 0
First 10 days after birth.
Secondary outcome [16] 0 0
Highest PEEP used during non-invasive ventilation
Timepoint [16] 0 0
Birth to 10 days of age.
Secondary outcome [17] 0 0
Duration of respiratory support
Timepoint [17] 0 0
36 week PMA.
Secondary outcome [18] 0 0
Postnatal steroid use
Timepoint [18] 0 0
36 week PMA.
Secondary outcome [19] 0 0
Inotrope use
Timepoint [19] 0 0
36 week PMA.
Secondary outcome [20] 0 0
Length of stay in hospital
Timepoint [20] 0 0
Up to 44 weeks PMA
Secondary outcome [21] 0 0
Oxygen requirement at discharge to home
Timepoint [21] 0 0
Up to 44 weeks PMA
Secondary outcome [22] 0 0
Patent ductus arteriosus requiring medical or surgical therapy in first 72 hours
Timepoint [22] 0 0
72 hours of age.
Secondary outcome [23] 0 0
Meeting the protocol criteria for failure of non-invasive ventilation during the intervention period
Timepoint [23] 0 0
Up to the first 20 minutes after commencing respiratory support following birth.

Eligibility
Key inclusion criteria
* 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).
Minimum age
23 Weeks
Maximum age
28 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2028
Actual
Sample size
Target
906
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Mater Misericordiae - South Brisbane
Recruitment hospital [2] 0 0
Women & Childrens Hospital Adelaide - Adelaide
Recruitment hospital [3] 0 0
Joan Kirner Women & Children's Hospital - VIC - Melbourne
Recruitment hospital [4] 0 0
The Royal Women's Hospital, Melbourne Australia - Parkville
Recruitment hospital [5] 0 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
3021 - Melbourne
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Austria
State/province [5] 0 0
Feldkirch
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
Italy
State/province [7] 0 0
Milan
Country [8] 0 0
Italy
State/province [8] 0 0
Florence
Country [9] 0 0
Italy
State/province [9] 0 0
Rome
Country [10] 0 0
Netherlands
State/province [10] 0 0
Amsterdam
Country [11] 0 0
Netherlands
State/province [11] 0 0
Nijmegen
Country [12] 0 0
Netherlands
State/province [12] 0 0
Veldhoven
Country [13] 0 0
Poland
State/province [13] 0 0
Poznan
Country [14] 0 0
United Kingdom
State/province [14] 0 0
England
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Scotland
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Leicester

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Pennsylvania
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Oxford
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Tingay, MBBS FRACP
Address 0 0
Royal Children's Hospital, Melbourne, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Tingay, MBBS FRACP
Address 0 0
Country 0 0
Phone 0 0
+61 3 9345 4023
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 [email protected] and [email protected].

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
6 months after publication of primary outcome.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04372953