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Trial registered on ANZCTR
Registration number
ACTRN12624001080516
Ethics application status
Approved
Date submitted
16/08/2024
Date registered
6/09/2024
Date last updated
6/09/2024
Date data sharing statement initially provided
6/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Lungs for Life: Effect of using wearable oximeters at home, supported by a virtual digital care package, on health in preterm babies
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Scientific title
Lungs for Life: Effect of using wearable oximeters at home, supported by a virtual digital care package, on health and hospitalisation events in preterm babies with bronchopulmonary dysplasia
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Secondary ID [1]
312669
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Preterm Babies
334646
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Bronchopulmonary Dysplasia
334647
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Hypoxemia
334648
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Condition category
Condition code
Reproductive Health and Childbirth
331226
331226
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0
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Childbirth and postnatal care
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Reproductive Health and Childbirth
331227
331227
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0
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Complications of newborn
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study intervention (“digital care group”) is comprised of a digital care package including continuous home oximetry monitoring from discharge until 6 months corrected postnatal age, weekly telehealth review and 24/7 central clinical telehealth support. Participants may receive home oxygen therapy as per local clinical standard of care.
Continuous home oximetry monitoring will be performed using Masimo SafetyNet equipment, including a remote Bluetooth device worn on infant's wrist from hospital discharge to 6 months postnatal corrected age.
Central Telehealth reviews will take approximately 10 minutes per session and will be comprised of a clinical review of oximetry data and discussion of tolerability, any technical or other study-related issues. Telehealth reviews will be performed by a delegated study physician or nurse.
Oximetry data are synced to a central server every minute and can be access by local site teams, sponsor staff and central 24/7 clinical support services. Adherence will also be monitored by local site staff.
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Intervention code [1]
329195
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Treatment: Devices
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Comparator / control treatment
The control group will receive usual care alone as per local clinical standard of care. Usual care does not involve home oximetry monitoring but may include remote and/or outpatient clinical reviews, depending on health service.
Participants may receive home oxygen therapy as per local clinical standard of care.
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Control group
Active
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Outcomes
Primary outcome [1]
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Proportion of infants with at least one hospitalisation (any cause)
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Assessment method [1]
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As determined by administrative data linkage
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Timepoint [1]
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Infants will be followed until 1 year of corrected postnatal age. The proportion of infants with at least one hospitalisation will be evaluated at the conclusion of the study.
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Secondary outcome [1]
438212
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Proportion of infants alive at 1 year corrected postnatal age
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Assessment method [1]
438212
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As determined by administrative data linkage. Infants will be deemed alive is death is not recorded at or prior to assessment timepoint.
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Timepoint [1]
438212
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Infants will be followed until 1 year of corrected postnatal age. The proportion of infants alive at 1 year corrected postnatal age will be evaluated at the conclusion of the study.
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Secondary outcome [2]
438213
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Rate of hospitalisations (any cause)
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Assessment method [2]
438213
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As determined by administrative data linkage.
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Timepoint [2]
438213
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Infants will be followed until 1 year of corrected postnatal age. The rate of hospitalisations will be evaluated at the conclusion of the study.
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Secondary outcome [3]
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Mean duration of hospitalisations (any cause)
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Assessment method [3]
438214
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As determined by administrative data linkage.
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Timepoint [3]
438214
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Infants will be followed until 1 year of corrected postnatal age. The mean duration of hospitalisations will be evaluated at the conclusion of the study.
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Secondary outcome [4]
438215
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Rate of emergency department presentations (any cause)
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Assessment method [4]
438215
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As determined by administrative data linkage.
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Timepoint [4]
438215
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Infants will be followed until 1 year of corrected postnatal age. The rate of emergency department presentations will be evaluated at the conclusion of the study.
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Secondary outcome [5]
438216
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Rate of general practitioner/paediatrician presentations (any cause)
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Assessment method [5]
438216
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As determined by administrative data linkage.
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Timepoint [5]
438216
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Infants will be followed until 1 year of corrected postnatal age. The rate of general practitioner/paediatrician presentations will be evaluated at the conclusion of the study.
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Secondary outcome [6]
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Cost of health service use
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Assessment method [6]
438217
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Health outcomes will be measured using natural units i.e. number of hospitalisations avoided. For the cost-effectiveness analysis, the incremental cost effectiveness ratio per hospitalisation avoided for the digital care group compared with usual care will be calculated. Health utilisation data will be sourced from administrative data linkage, and out-of-pocket costs from parent questionnaire report.
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Timepoint [6]
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1 year corrected postnatal age.
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Secondary outcome [7]
438218
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Infant growth velocity
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Assessment method [7]
438218
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Change in infant growth velocity, as measured in composite from bare weight, length and head circumference z-scores by weight scales, infant length board and measuring tape, respectively.
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Timepoint [7]
438218
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From randomisation to 1 year corrected postnatal age
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Secondary outcome [8]
438219
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Quality of infant sleep, as reported by the Brief Infant Sleep Questionnaire Short Form (BISQ-R-SF)
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Assessment method [8]
438219
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Responses to each item on the BISQ-R-SF will be compared between groups
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Timepoint [8]
438219
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1 year corrected postnatal age.
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Secondary outcome [9]
438220
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Infant neurodevelopment
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Assessment method [9]
438220
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Ages and Stages Questionnaire
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Timepoint [9]
438220
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1 year corrected postnatal age.
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Secondary outcome [10]
438221
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Rate of respiratory-related hospitalisations
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Assessment method [10]
438221
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As determined by administrative data linkage. Respiratory-related hospital admissions are defined as admissions for a condition coded in the World Health Organisation (WHO) International Classification of Disease (ICD) version 10 as J00-99. Information collected will include duration of admission, outcome of admission (deceased/discharged from hospital) and diagnosis.
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Timepoint [10]
438221
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Infants will be followed until 1 year of corrected postnatal age. The rate of respiratory-related hospitalisations will be evaluated at the conclusion of the study.
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Secondary outcome [11]
438222
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Mean duration of respiratory-related hospitalisations
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Assessment method [11]
438222
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As determined by administrative data linkage. Respiratory-related hospital admissions are defined as admissions for a condition coded in the World Health Organisation (WHO) International Classification of Disease (ICD) version 10 as J00-99. Information collected will include duration of admission, outcome of admission (deceased/discharged from hospital) and diagnosis.
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Timepoint [11]
438222
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Infants will be followed until 1 year of corrected postnatal age. The mean duration of respiratory-related hospitalisations will be evaluated at the conclusion of the study.
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Secondary outcome [12]
438224
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Rate of respiratory-related emergency department presentations
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Assessment method [12]
438224
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As determined by administrative data linkage. Respiratory-related emergency department presentations are defined as presentations for a condition coded in the World Health Organisation (WHO) International Classification of Disease (ICD) version 10 as J00-99. Information collected will include duration of admission, outcome of admission (deceased/discharged from hospital) and diagnosis.
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Timepoint [12]
438224
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Infants will be followed until 1 year of corrected postnatal age. The rate of respiratory-related emergency department presentations will be evaluated at the conclusion of the study.
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Secondary outcome [13]
438598
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Proportion of infants commenced on home oxygen therapy (HOT) after hospital discharge
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Assessment method [13]
438598
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Proportions will be compared between the two groups. By definition, infants discharged on HOT are not included in this outcome. Data is per parent questionnaire report.
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Timepoint [13]
438598
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Infants will be followed until 1 year of corrected postnatal age. The proportion of infants commenced on home oxygen therapy will be evaluated at the conclusion of the study.
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Secondary outcome [14]
438599
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Mean corrected postnatal age at discontinuation of supplemental oxygen
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Assessment method [14]
438599
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Interval between the calculated estimated date of delivery of the date of last dose of fraction of inspired oxygen (FiO2) greater than 0.21. Infants who do not receive home oxygen therapy are not included in this outcome. Data is per parent questionnaire report.
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Timepoint [14]
438599
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Infants will be followed until 1 year of corrected postnatal age. The mean corrected postnatal age will be evaluated at the conclusion of the study.
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Secondary outcome [15]
438600
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Acceptability and feasibility of home oximetry
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Assessment method [15]
438600
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Mixed methods approach assessed in composite as a single secondary outcome. Quantitative assessments will be made via a 5-point ordinal scale using the Acceptability of Intervention Measure (AIM), the Implementation Appropriateness Measure (IAM) and the Feasibility of Intervention Measure (FIM). Higher scores indicate greater acceptability, appropriateness and feasibility respectively. Qualitative assessments will be made via parent and clinician interview, guided by an interview guide.
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Timepoint [15]
438600
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AIM/IAM/FIM will be performed at end of treatment (approximately 6 months corrected age). Parent interviews will be performed following randomisation, and at end of treatment (approximately 6 months corrected age). Clinician interviews will be performed during the intervention and follow-up period (to approximately 9 months corrected postnatal age).
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Eligibility
Key inclusion criteria
1. Infants born before 32 weeks postmenstrual age who are diagnosed with Bronchopulmonary Dysplasia (BPD).
2. Smartphone access compatible with Masimo SafetyNet smartphone application: iOS v11.0+ or Android v6.0+, with Bluetooth 4.2+
3. Signed, written informed parent or guardian consent.
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Minimum age
0
Days
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Maximum age
32
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Infants greater than 41+6 weeks postmenstrual age at randomisation
2. No internet (minimum 3G) (<1% Australian adults) or compatible smartphone (<7% all Australians) access at usual place of residence
3. Infants with congenital abnormalities that could affect survival, growth, respiratory status or oxygenation or complex respiratory needs
4. Infants with known allergic reactions to foam rubber products and/or adhesive tape
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Study design
Purpose of the study
Treatment
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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)
Central randomisation by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation with 1:1 allocation, stratified by study site, usual place of residence and postmenstrual age at birth. Infants of multiple births will be assigned to the same intervention.
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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
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
1/04/2027
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Actual
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Date of last data collection
Anticipated
1/04/2028
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Actual
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Sample size
Target
262
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Funding & Sponsors
Funding source category [1]
317104
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Government body
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Name [1]
317104
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Medical Research Future Fund, National Health and Medical Research Council
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Address [1]
317104
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Country [1]
317104
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
319362
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None
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Name [1]
319362
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Address [1]
319362
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Country [1]
319362
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315853
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
315853
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https://www.hnehealth.nsw.gov.au/research-office/research_ethics
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Ethics committee country [1]
315853
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Australia
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Date submitted for ethics approval [1]
315853
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30/05/2024
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Approval date [1]
315853
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03/07/2024
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Ethics approval number [1]
315853
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2024/ETH01183
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Summary
Brief summary
Doctors do not currently know the best way to care for babies with BPD after they go home from hospital. The Lungs for Life study will compare two ways of caring for babies with Bronchopulmonary Dysplasia (BPD) after they go home from hospital. Babies in the study will receive either (a) a digital care package including oxygen monitoring; or (b) the usual care for babies with BPD. We want to find out whether the digital care package helps babies, their families and healthcare professionals. If it does, we may be able to standardise care and improve the treatment of BPD.
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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
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Prof Ju Lee Oei
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Address
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c/o Lungs for Life Coordinating Centre, NHMRC Clinical Trials Centre, University of Sydney, 92-94 Parramatta Road, Camperdown NSW 2050
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Country
135998
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Australia
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Phone
135998
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+61 409 223 005
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Fax
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Email
135998
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[email protected]
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Contact person for public queries
Name
135999
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Sarah Finalyson
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Address
135999
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NHMRC Clinical Trials Centre, University of Sydney, 92-92 Parramatta Road, Camperdown NSW 2050
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Country
135999
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Australia
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Phone
135999
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+61 2 9562 5347
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Fax
135999
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Email
135999
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[email protected]
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Contact person for scientific queries
Name
136000
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Ju Lee Oei
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Address
136000
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c/o Lungs for Life Coordinating Centre, NHMRC Clinical Trials Centre, University of Sydney, 92-94 Parramatta Road, Camperdown NSW 2050
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Country
136000
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Australia
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Phone
136000
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+61 2 9562 5000
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Fax
136000
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Email
136000
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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