RecruitingACTRN12624001080516

Lungs for Life: Effect of using wearable oximeters at home, supported by a virtual digital care package, on health in preterm babies

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

Sponsor

The University of Sydney

Enrollment

262 participants

Start Date

Dec 17, 2025

Study Type

Interventional

Conditions

Preterm Babies Hypoxemia Bronchopulmonary Dysplasia

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.

Eligibility

Sex: Both males and femalesMin Age: 0 DayssMax Age: 32 Weekss

Plain Language Summary

Simplified for easier understanding

This study, called Lungs for Life, is designed to help babies born too early who develop a lung condition called Bronchopulmonary Dysplasia (BPD). BPD occurs when a premature baby's lungs are fragile and become damaged during the time they need breathing support in hospital. Once these babies go home, it can be hard to know when they're struggling to breathe. The study tests whether a digital care package — which includes a wearable oxygen monitor that parents can use at home — leads to better health outcomes for babies with BPD compared to standard care. Families in the digital care group will be connected to healthcare professionals virtually, allowing any problems to be caught early. Your baby may be eligible if they were born before 32 weeks of pregnancy and have been diagnosed with BPD. You'll also need a compatible smartphone (iOS or Android) and internet access at home. Babies with other serious medical conditions affecting breathing or growth are not eligible. This study aims to find the best way to support these vulnerable babies and their families after leaving hospital.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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, 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.