Automated oxygen control for preterm babies on non-invasive support
Official title: Randomised Controlled Trial of Closed-loop Automated Oxygen Control in Preterm Infants Receiving Non-invasive Respiratory Support
Run by King's College Hospital NHS Trust · NCT07622563 · Data updated 2026-11-12
This trial tests whether closed-loop automated oxygen control helps preterm babies on non-invasive ventilation reach target oxygen levels more often and spend less time on supplemental oxygen compared with manual control.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Weeks to 34 Weeks |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | June 12, 2026 |
| Main results expected | June 2027 |
| Study ends | September 2027 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT07622563 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Preterm infants under 34 weeks gestation on non-invasive respiratory support (NIPPV, nasal CPAP, or HHFNC), at any postnatal age, whose guardians consent to participate.
✕Probably not a fit
Infants with complex congenital heart disease or major congenital abnormalities may not benefit from automated oxygen control.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares closed-loop automated oxygen control (CLAC) with manual oxygen tuning in preterm infants under 34 weeks gestation receiving non-invasive respiratory support. Conducted at King's College Hospital NICU, eligible families are approached for consent. Infants are assigned to CLAC or manual FiO2 adjustments, with outcomes including time on supplemental oxygen, time in target oxygen saturation, frequency of FiO2 changes, and rates of adverse events such as bronchopulmonary dysplasia. Background data notes that CLAC in prior studies improved saturation control and reduced oxygen exposure, potentially shortening oxygen and ventilation durations. The study seeks to determine if such benefits extend to non-invasive support settings and influence longer-term respiratory outcomes.
Why it matters
Potential benefit: If successful, CLAC could help preterm infants maintain stable oxygen levels more consistently and reduce exposure to respiratory support.
How similar studies have gone: Prior randomized studies in similar populations showed improved oxygen targeting and shorter oxygen/ventilation durations with CLAC, including reductions in BPD in some cohorts.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
King's College Hospital NHS Foundation Trust
London, United Kingdom Recruiting
Study contacts
- Principal investigator: Ourania Kaltsogianni — King's College Hospital NHS Trust
- Study coordinator: Ourania Kaltsogianni, MD (Res)
- Email: ourania.kaltsogianni@nhs.net
- Phone: +44020 3299 9000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.