None listed
Conditions
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.
Interventions
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 hosp
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.
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, fortnightly 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
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, fortnightly 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 centralised, state-based teams of respiratory care providers. Oximetry data are synced to a central server every minute and can be access by local site teams, sponsor staff, central 24/7 clinical support services and centralised, state-based teams of respiratory care providers. Adherence will also be monitored by local site staff.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 32 Weeks
Healthy volunteers
No
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.
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
Outcome results
None listed