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Trial registered on ANZCTR
Registration number
ACTRN12625001100482
Ethics application status
Approved
Date submitted
15/09/2025
Date registered
9/10/2025
Date last updated
9/10/2025
Date data sharing statement initially provided
9/10/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Assessing the use of the Juno Monitor on mask leak during Neonatal Resuscitation Training
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Scientific title
Assessing the use of the Juno Monitor on mask leak during Neonatal Resuscitation Training of non-specialist healthcare professionals
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Secondary ID [1]
315287
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
JUMP START
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neonatal resuscitation
338887
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Prematurity
338888
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Condition category
Condition code
Reproductive Health and Childbirth
335178
335178
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0
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Complications of newborn
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Emergency medicine
335309
335309
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0
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Resuscitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Training will be delivered on a premature mannequin (Lifecast Body Simulation Ltd, London, UK) will be used, which resembles a 28-week gestation newborn. Ventilation will be delivered using a small size Fisher and Paycal (Auckland, New Zealand) facemask and T-piece resuscitaire (Neopuff, Fisher & Paykel Healthcare, Auckland, New Zealand) with settings of 8l/min gas flow, Peak Inspiratory Pressure (PIP) 25cmH20 and Peak End Expiratory Pressure (PEEP) 5cmH20, which are standard settings for a preterm newborn.
Intervention arm will receive the JUNO training device. In the intervention group each healthcare professional (HCP) will be demonstrated standard facemask technique. Training will be delivered by a Neonatologist from the Newborn Emergency Transfer Service of Western Australia (NETS-WA). The facilitator will assist the HCP to achieve good chest rise determined via visual inspection. In addition to this standard training, the intervention group will receive Juno monitor training. During the Juno monitor training, the “training mode” will be displayed to give real-time feedback. The facilitator will use this information to assist the HCP until “no leak” has been achieved, as well as achieving appropriate volumes and respiratory rates for the estimated weight of the baby.
The Juno training monitor (ResusRight™, Sydney, Australia) has been designed specifically for education. This device fits in-line to a self-inflating bag or pressure limited flow regulator. It provides real time feedback on leak percentage, tidal volume and respiratory rate.
Training will be delivered in a group format to between 8-10 participants at a time. Each participant will then have the opportunity to practice with the Juno monitor one-on-one during the airway station of the NeoStars course which is 45-minutes in duration.
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Intervention code [1]
332077
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Treatment: Devices
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Comparator / control treatment
Training will be delivered on a premature mannequin (Lifecast Body Simulation Ltd, London, UK) will be used, which resembles a 28-week gestation newborn. Ventilation will be delivered using a small size Fisher and Paycal (Auckland, New Zealand) facemask and T-piece resuscitaire (Neopuff, Fisher & Paykel Healthcare, Auckland, New Zealand) with settings of 8l/min gas flow, Peak Inspiratory Pressure (PIP) 25cmH20 and Peak End Expiratory Pressure (PEEP) 5cmH20, which are standard settings for a preterm newborn
Control arm will receive standard training. Each healthcare professional (HCP) will be demonstrated standard facemask technique. Training will be delivered by a Neonatologist from the Newborn Emergency Transfer Service of Western Australia (NETS-WA). The facilitator will assist the HCP to achieve good chest rise determined via visual inspection. Training will be delivered in a group format to between 8-10 participants at a time. Each participant will then have the opportunity to practice one-on-one during the airway station of the NeoStars course which is 45-minutes in duration.
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Control group
Active
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Outcomes
Primary outcome [1]
342797
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Mask leak
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Assessment method [1]
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Percentage of time spent with a mask leak <30% as determined by the Juno Training Monitor analytics which provides a downloadable data table
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Timepoint [1]
342797
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Post training Simulation Test completed within 4-hours of the intervention.
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Secondary outcome [1]
452145
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Mild mask leak
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Assessment method [1]
452145
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Percentage of time spent with some mild mask leak (30-60%) as determined by the Juno Training Monitor analytics which provides a downloadable data table
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Timepoint [1]
452145
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Post training Simulation Test completed within 4-hours of the intervention.
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Secondary outcome [2]
452146
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Tidal volume
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Assessment method [2]
452146
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Time spent in the target 4-6ml/kg volume range as determined by the Juno Training Monitor analytics which provides a downloadable data table
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Timepoint [2]
452146
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Post training Simulation Test completed within 4-hours of the intervention.
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Secondary outcome [3]
452147
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Respiratory rate
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Assessment method [3]
452147
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Time spent In target respiratory rate range (30-60 breaths per minute) determined by the Juno Training Monitor analytics which provides a downloadable data table
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Timepoint [3]
452147
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Post training Simulation Test completed within 4-hours of the intervention.
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Secondary outcome [4]
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Severe mask leak
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Assessment method [4]
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Percentage of time spent with severe mask leak (>60%) determined by the Juno Training Monitor analytics which provides a downloadable data table
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Timepoint [4]
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Post training Simulation Test completed within 4-hours of the intervention.
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Eligibility
Key inclusion criteria
i. Healthcare professional participating in a NeoStars stabilisation and resuscitation course
ii. Signed informed consent from participant.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
i. RACP recognised neonatologist.
ii. Refusal of consent
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed. Allocation involved contacting the holder of the allocation schedule who was at central administration site.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table created by computer software. Stratified according to clinical role.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
An equal allocation of 30 HCPs per group (60 in total) is required to observe a statistically significant (alpha equal to 0.05) difference in the proportion of participants achieving at least 10% improvement with greater than 80% power, assuming standard training alone will increase the “no leak” time for all participants by 10%. The estimate is calculated via simulation using parameters from a prior study using the Juno RFM with a T-piece resuscitator on pre-term manikins in a sample of experienced neonatal staff. Using this study’s parameters, we assume a baseline level of 65% time with no leak (standard deviation equals 15%), and 85% time with no leak in the Juno group after training (standard deviation equals 15%). For those in the control group), we assume a 10% improvement due to training resulting in 71.5% time with no leak (standard deviation equals 15%). We ran 1000 simulations, using these parameters, and calculated whether each participant achieved an improvement of more than 10% from their individual baseline score. The resulting dichotomous variable was compared to group assignment by means of Chi-squared test. After accounting for 10% drop out per group, we maintain at least 80% power.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
11/04/2025
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Date of last participant enrolment
Anticipated
21/11/2025
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Actual
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Date of last data collection
Anticipated
21/11/2025
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Actual
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Sample size
Target
60
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Accrual to date
32
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
28491
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Perth Children's Hospital - Nedlands
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Recruitment postcode(s) [1]
44726
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
319859
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Government body
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Name [1]
319859
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Child and Adolescent Health Service (CAHS)
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Address [1]
319859
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Country [1]
319859
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Australia
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Primary sponsor type
Hospital
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Name
Perth Children's Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
322385
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None
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Name [1]
322385
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Address [1]
322385
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Country [1]
322385
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318413
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Child and Adolescent Health Service Human Research Ethics Committee
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Ethics committee address [1]
318413
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https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval
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Ethics committee country [1]
318413
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Australia
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Date submitted for ethics approval [1]
318413
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11/12/2024
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Approval date [1]
318413
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07/01/2025
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Ethics approval number [1]
318413
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Summary
Brief summary
Background: Transition to breathing at birth is dependent on sufficient entry of air into the lungs and is the cornerstone of neonatal resuscitation. For the 5-10% of babies that require assistance at birth, the equipment used includes a self-inflating bag or pressure limited flow regulator. Good mask technique is essential to reduce leak and provide effective ventilation. In preterm resuscitation, the rate of respiration and tidal volume delivered are also key in reducing air leak and protecting against volutrauma to the preterm lung. Newborn resuscitation training performed on preterm mannequins relies on the visual feedback from instructors on chest rise and fall. The JUNO respiratory function monitor is an in-line device that serves as a training aid. It provides real-time feedback on percentage of leak, respiratory rate and tidal volume delivered with each breath administered. There is emerging evidence of its utility in the training of neonatal resuscitation within the neonatal community. This study aims to assess its effectiveness in reducing facemask leak within the non-specialist community. Objectives: The aim of this project is to assess whether the Juno Training Monitor is superior to current training methods at reducing mask leak during neonatal resuscitation within the non-neonatal specialist community. Project Plan: Candidates attending a neonatal stabilisation course will be randomised to either facemask ventilation training with real-time feedback from the JUNO training monitor, or to standard training. A 30-second simulation post-training with the monitor blinded will then be performed. The primary outcome will be the amount of time spent with a mask lead <30%. Secondary outcomes will include the rate of respiration and tidal volume administered.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
144106
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Dr Adam Heathcote
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Address
144106
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King Edward Memorial Hospital, 374 Bagot Rd, Subiaco, WA, 6008
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Country
144106
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Australia
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Phone
144106
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+61 08 6458 1262
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Fax
144106
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Email
144106
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[email protected]
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Contact person for public queries
Name
144107
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Adam Heathcote
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Address
144107
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King Edward Memorial Hospital, 374 Bagot Rd, Subiaco, WA, 6008
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Country
144107
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Australia
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Phone
144107
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+61 08 6458 2222
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Fax
144107
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Email
144107
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[email protected]
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Contact person for scientific queries
Name
144108
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Adam Heathcote
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Address
144108
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King Edward Memorial Hospital, 374 Bagot Rd, Subiaco, WA, 6008
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Country
144108
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Australia
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Phone
144108
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+61 08 6458 2222
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Fax
144108
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Email
144108
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
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Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
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Requires a scientifically sound proposal or protocol
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Requires approval by an ethics committee
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Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
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De-identified individual participant data:
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All outcomes data
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Published results
What types of analyses could be done with individual participant data?
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Systematic reviews and meta-analyses
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Studies exploring new research questions
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Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
JUMP START PROTOCOL.pdf
Informed consent form
265629_JUMP START PICF v1.1 6JAN2025 clean.pdf
Ethical approval
JUNO Ethics Letter.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF