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Recruiting NCT07622563

Automated Oxygen Control in Preterms on Non-invasive Ventilation

Conditions: Infant, Premature, Airway Morbidity

Sex: All
Ages: 22 Weeks – 34 Weeks
Healthy volunteers: No
Phase: NA
Enrollment: 76
Sponsor: King's College Hospital NHS Trust

Location: King's College Hospital NHS Foundation Trust London

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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07622563). StuddyBuddy aggregates publicly available trial information.