None listed
Conditions
Brief summary
This research proposal seeks funding to conduct a vanguard randomised controlled trial (RCT) of automated control of oxygen therapy in preterm infants <28 weeks gestation in Australian neonatal Units. Our hypothesis is that automated oxygen control using a control device developed by our research team can produce a sustained improvement in time in the desired oxygen saturation (SpO2) target range over many weeks of hospitalisation, reduce blood markers of oxygen toxicity and oxygen debt, and thus have the potential to improve outcome. Background Almost all extremely preterm infants <28 weeks gestation receive supplemental oxygen during their first hospitalisation, with fraction of inspired oxygen (FiO2) titrated to target a preferred SpO2 range. Both hypoxia and hyperoxia are known to be associated with adverse outcomes, including mortality, chronic lung disease, retinopathy and necrotizing enterocolitis. SpO2 targeting is, however, fraught with difficulty, with manual oxygen control targeting the desired SpO2 range less than 50% of the time. Automated oxygen control may offer a solution, and existing control algorithms increase time in target range by around 10% in short term studies. Whether automated control can produce sustained improvements in SpO2 targeting, and do so in all individuals, are unknown. Research Proposal Preterm infants 23+0 to 27+6 weeks gestation (N=180) will be randomly allocated to automated oxygen control, or standard manual control, from early life until 36 weeks post-menstrual age (PMA). Automated control will be applied for as much of the time as possible, and with all manner of respiratory support modalities. FiO2 and SpO2 will be logged continuously, and blood markers of oxygen toxicity and debt examined at days 1, 7, 28 and at 36 weeks PMA. Time in the SpO2 target range (primary outcome), blood markers of oxidation and hypoxia, survival and complications of prematurity will be compared between groups.
Interventions
Automated control of inspired oxygen therapy will be administered using a custom-built device incorporating a novel, adaptive and intuitive control algorithm (VDL1.1.). This device receives SpO2 input from an oximeter, compares the value with the midpoint of the desired SpO2 range, and provides an output, which is an updated value for FiO2. In subjects randomised to automated control, this device will be applied before 48 hours of life (i.e. within 24 hours of randomisation) and used until 36 we
Automated control of inspired oxygen therapy will be administered using a custom-built device incorporating a novel, adaptive and intuitive control algorithm (VDL1.1.). This device receives SpO2 input from an oximeter, compares the value with the midpoint of the desired SpO2 range, and provides an output, which is an updated value for FiO2. In subjects randomised to automated control, this device will be applied before 48 hours of life (i.e. within 24 hours of randomisation) and used until 36 weeks post-menstrual age or until respiratory support has ceased. The SpO2 target range will be 90-94%. Compliance with automated control will be monitored by local research personnel.
Sponsors
Menzies Institute for Medical Research, University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 24 Hours
Healthy volunteers
No
Inclusion criteria
Gestation at birth 23 weeks 0 days to 27 weeks 6 days by best obstetric estimate. Age <24 hours, and managed in room air or supplemental oxygen. Signed parental consent.
Exclusion criteria
Withdrawal of active treatment being considered. Congenital anomaly likely to adversely affect outcome. Lack of availability of automated control device or study personnel.
Outcome results
None listed