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Automated Oxygen Control in Preterms on Non-invasive Ventilation

NCT07622563 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-08-05

No results posted yet for this study

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.

Conditions

  • Infant
  • Premature
  • Airway Morbidity

Interventions

DEVICE

Closed 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.

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Ourania Kaltsogianni · King's College Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-12
Primary Completion
2027-06-30
Completion
2027-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07622563 on ClinicalTrials.gov