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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
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
Secondary ID [1] 312669 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm Babies 334646 0
Bronchopulmonary Dysplasia 334647 0
Hypoxemia 334648 0
Condition category
Condition code
Reproductive Health and Childbirth 331226 331226 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 331227 331227 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 329195 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 338999 0
Proportion of infants with at least one hospitalisation (any cause)
Timepoint [1] 338999 0
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.
Secondary outcome [1] 438212 0
Proportion of infants alive at 1 year corrected postnatal age
Timepoint [1] 438212 0
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.
Secondary outcome [2] 438213 0
Rate of hospitalisations (any cause)
Timepoint [2] 438213 0
Infants will be followed until 1 year of corrected postnatal age. The rate of hospitalisations will be evaluated at the conclusion of the study.
Secondary outcome [3] 438214 0
Mean duration of hospitalisations (any cause)
Timepoint [3] 438214 0
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.
Secondary outcome [4] 438215 0
Rate of emergency department presentations (any cause)
Timepoint [4] 438215 0
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.
Secondary outcome [5] 438216 0
Rate of general practitioner/paediatrician presentations (any cause)
Timepoint [5] 438216 0
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.
Secondary outcome [6] 438217 0
Cost of health service use
Timepoint [6] 438217 0
1 year corrected postnatal age.
Secondary outcome [7] 438218 0
Infant growth velocity
Timepoint [7] 438218 0
From randomisation to 1 year corrected postnatal age
Secondary outcome [8] 438219 0
Quality of infant sleep, as reported by the Brief Infant Sleep Questionnaire Short Form (BISQ-R-SF)
Timepoint [8] 438219 0
1 year corrected postnatal age.
Secondary outcome [9] 438220 0
Infant neurodevelopment
Timepoint [9] 438220 0
1 year corrected postnatal age.
Secondary outcome [10] 438221 0
Rate of respiratory-related hospitalisations
Timepoint [10] 438221 0
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.
Secondary outcome [11] 438222 0
Mean duration of respiratory-related hospitalisations
Timepoint [11] 438222 0
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.
Secondary outcome [12] 438224 0
Rate of respiratory-related emergency department presentations
Timepoint [12] 438224 0
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.
Secondary outcome [13] 438598 0
Proportion of infants commenced on home oxygen therapy (HOT) after hospital discharge
Timepoint [13] 438598 0
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.
Secondary outcome [14] 438599 0
Mean corrected postnatal age at discontinuation of supplemental oxygen
Timepoint [14] 438599 0
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.
Secondary outcome [15] 438600 0
Acceptability and feasibility of home oximetry
Timepoint [15] 438600 0
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).

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.
Minimum age
0 Days
Maximum age
32 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
1/04/2027
Actual
Date of last data collection
Anticipated
1/04/2028
Actual
Sample size
Target
262
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 317104 0
Government body
Name [1] 317104 0
Medical Research Future Fund, National Health and Medical Research Council
Country [1] 317104 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319362 0
None
Name [1] 319362 0
Address [1] 319362 0
Country [1] 319362 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315853 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 315853 0
Ethics committee country [1] 315853 0
Australia
Date submitted for ethics approval [1] 315853 0
30/05/2024
Approval date [1] 315853 0
03/07/2024
Ethics approval number [1] 315853 0
2024/ETH01183

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

Contacts
Principal investigator
Name 135998 0
Prof Ju Lee Oei
Address 135998 0
c/o Lungs for Life Coordinating Centre, NHMRC Clinical Trials Centre, University of Sydney, 92-94 Parramatta Road, Camperdown NSW 2050
Country 135998 0
Australia
Phone 135998 0
+61 409 223 005
Fax 135998 0
Email 135998 0
ju-lee.oei@sydney.edu.au
Contact person for public queries
Name 135999 0
Sarah Finalyson
Address 135999 0
NHMRC Clinical Trials Centre, University of Sydney, 92-92 Parramatta Road, Camperdown NSW 2050
Country 135999 0
Australia
Phone 135999 0
+61 2 9562 5347
Fax 135999 0
Email 135999 0
lungsforlife.study@sydney.edu.au
Contact person for scientific queries
Name 136000 0
Ju Lee Oei
Address 136000 0
c/o Lungs for Life Coordinating Centre, NHMRC Clinical Trials Centre, University of Sydney, 92-94 Parramatta Road, Camperdown NSW 2050
Country 136000 0
Australia
Phone 136000 0
+61 2 9562 5000
Fax 136000 0
Email 136000 0
ju-lee.oei@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.