NCT07622563 Automated Oxygen Control in Preterms on Non-invasive Ventilation
| NCT ID | NCT07622563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King's College Hospital NHS Trust |
| Condition | Infant |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2026-06-12 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 76 participants in total. It began in 2026-06-12 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Ourania Kaltsogianni
PRINCIPAL INVESTIGATOR
King's College Hospital NHS Trust
Frequently Asked Questions
Who can join the NCT07622563 clinical trial?
This trial is open to participants of all sexes, aged 22 Weeks or older, up to 34 Weeks, studying Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07622563 currently recruiting?
Yes, NCT07622563 is actively recruiting participants. Contact the research team at ourania.kaltsogianni@nhs.net for enrollment information.
Where is the NCT07622563 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07622563 clinical trial?
NCT07622563 is sponsored by King's College Hospital NHS Trust. The principal investigator is Ourania Kaltsogianni at King's College Hospital NHS Trust. The trial plans to enroll 76 participants.