RecruitingNot ApplicableNCT07622563

Automated Oxygen Control in Preterms on Non-invasive Ventilation

Randomised Controlled Trial of Closed-loop Automated Oxygen Control in Preterm Infants Receiving Non-invasive Respiratory Support


Sponsor

King's College Hospital NHS Trust

Enrollment

76 participants

Start Date

Jun 12, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 22 WeeksMax Age: 34 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Closed loop automated oxygen control for people with airway morbidity, infant, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEClosed loop automated oxygen control

The OxyGenie closed-loop oxygen saturation monitoring software (Inspiration Healthcare) uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study if deemed appropriate by the clinical team.


Locations(1)

King's College Hospital NHS Foundation Trust

London, United Kingdom

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NCT07622563


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