Not Yet RecruitingNot Applicable

Automated Oxygen Control in Preterms on Non-invasive Ventilation

United Kingdom76 participantsStarted 2026-06-01

Plain-language summary

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.

Who can participate

Age range

22 Weeks – 34 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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. Exclusion Criteria: * Infants with congenital cyanotic heart disease. * Infants with other know major congenital abnormalities.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The length of non-invasive ventilation

Timeframe: Through study completion, up to 36 weeks post menstrual age

Trial details

NCT IDNCT07622563

SponsorKing's College Hospital NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Ourania Kaltsogianni, MD (Res)

+44020 3299 9000 ourania.kaltsogianni@nhs.net

View on ClinicalTrials.gov More Infant trials