Automated Oxygen Control in Preterms on Non-invasive Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-34
SponsorKing's College Hospital NHS Trust
About this trial
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
This trial does not accept healthy volunteersQualifiers
non-invasive positive pressure ventilation (NIPPV)
nasal CPAP
HHFNC oxygen, either as primary or post extubation respiratory support.
Disqualifiers
Infants with congenital cyanotic heart disease.
Infants with other know major congenital abnormalities.
Trial design
Design model
Parallel
Treatments tested in this trial
Closed loop automated oxygen control
DeviceThe 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Automated oxygen controlExperimental treatment 1 intervention
Group B: Manual oxygen controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The length of non-invasive ventilation
Number of days participant receives non-invasive ventilation
Time frame
Through study completion, up to 36 weeks post menstrual ageSecondary outcomes
1
The change in the time spent within oxygen saturation targets
Percentage of time with oxygen saturation levels between 91-95%.
Time frame
Through study completion, up to 36 weeks post menstrual age2
The change in the time spent in hypoxia (SpO2<80%)
Percentage of time with oxygen saturation levels below 80%
Time frame
Through study completion, up to 36 weeks post menstrual age3
The change in the time spent in hyperoxia
Percentage of time with oxygen saturation levels above 98%.
Time frame
Through study completion, up to 36 weeks post menstrual age4
The change in the number of manual adjustments required
Absolute difference in number of manual FiO2 adjustments
Time frame
Through study completion, up to 36 weeks post menstrual ageSponsors and contacts
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Source ClinicalTrials.gov