Automated oxygen control in preterms on non-invasive ventilation
Research type
Research Study
Full title
Randomised controlled trial of closed-loop automated oxygen control in preterm infants receiving non-invasive respiratory support
IRAS ID
366356
Contact name
Anne Greenough
Contact email
Sponsor organisation
King's College Hospital
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Preterm infants frequently require supplemental oxygen but its use has been associated with complications. In addition, maintaining oxygen saturations within target range can be difficult as neonates experience frequent episodes of intermittent hypoxia or hyperoxia that correlate poorly with clinical outcomes. Closed-loop automated oxygen control (CLAC) systems may represent a solution to the poor compliance and reduce complications. In preterm ventilated infants, CLAC improves achievement of oxygen saturation targets and has been associated with shorter durations of mechanical ventilation and supplemental oxygen .
Preterm infants are increasingly managed on non-invasive respiratory support with an aim to minimise lung injury and reduce respiratory morbidity. CLAC could further improve respiratory outcomes in this population.
This randomised controlled trial aims to investigate the effectiveness of CLAC in preterm infants receiving non-invasive respiratory support. The study will take place at a tertiary unit. Parents of infants born at less than 34 weeks of gestation and receiving non-invasive respiratory support will be approached, informed and if appropriate consented to join the trial.
Participants will be randomised to receiving either automated or manual oxygen control from enrollment until weaning non-invasive ventilation.
The study will measure outcomes including the durations of non invasive ventilation and supplementary oxygen treatment, the percentage of time spent within oxygen saturation targets, the incidences of hypoxia and hyperoxia, the number of manual FiO2 adjustments required, the length of neonatal unit stay, and the incidence of bronchopulmonary dysplasia at 36 weeks postmenstrual age. Results will be compared between the two groups.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
26/WM/0075
Date of REC Opinion
15 May 2026
REC opinion
Further Information Favourable Opinion