Automated Oxygen Control in Preterms on Non-invasive Ventilation
Recruiting now · Not applicable
Conditions studied: Infant, Premature, Airway Morbidity
In brief
This randomised controlled trial aims to investigate the effectiveness of closed-loop automated oxygen control (CLAC) in preterm infants receiving non-invasive respiratory support and determine if it reduces the duration of supplementary oxygen treatment and improves achievement of oxygen saturation targets, reduces the incidences of hypoxia and hyperoxia, the number of manual adjustments to the inspired oxygen concentration (FiO2), and adverse outcomes including bronchopulmonary dysplasia (BPD). The study will take place at King's College Hospital neonatal intensive care unit (NICU). Parents of preterm 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. The study will measure outcomes including the duration of 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 overall duration of non-invasive respiratory support and length of neonatal unit stay, and the incidence of BPD at 36 weeks postmenstrual age (PMA). Results will be compared between the two groups.
Key facts
- Study ID
- NCT07622563
- Run by
- King's College Hospital NHS Trust
- People needed
- 76
- Starts
- 2026-06-12
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Preterm infants <34 weeks of gestation and at any postnatal age on non-invasive respiratory support including:
- non-invasive positive pressure ventilation (NIPPV)
- nasal CPAP
- HHFNC oxygen, either as primary or post extubation respiratory support.
You may not qualify if…
- Infants with congenital cyanotic heart disease.
- Infants with other know major congenital abnormalities.
Where it is running
- King's College Hospital NHS Foundation Trust — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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