Automated Oxygen Control in Preterms on Non-invasive Ventilation

May 27, 2026 updated by: King's College Hospital NHS Trust

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Preterm infants frequently require supplemental oxygen to achieve adequate oxygen delivery to the tissues and allow for normal cell metabolism. Oxygen treatment, although life-saving, can further increase the risk of complications. Hyperoxia leads to the development of reactive oxide species (ROS) and increases oxidative stress for the neonates due to their immature antioxidant defence systems. Oxidative stress increases the risk of complications such as bronchopulmonary dysplasia and retinopathy of prematurity (ROP). On the other hand, hypoxia increases morbidity and mortality.

Studies have demonstrated that automated compared to manual oxygen control systems in preterm ventilated infants result in an improvement in the achievement of oxygen saturation targets, reduced time spent in hypoxia and hyperoxia and fewer manual adjustments to the inspired oxygen concentration. In addition, CLAC has been associated with earlier weaning of the inspired oxygen. In a RCT in preterm ventilated infants, CLAC was associated with shorter durations of mechanical ventilation (MV) and supplemental oxygen and reductions in the incidence of BPD and the proportion of infants discharged on home oxygen.

Preterm infants are increasingly managed on non-invasive respiratory support with an aim to minimise lung injury and reduce respiratory morbidity. Optimisation of supplemental oxygen treatment could further improve respiratory outcomes in this population. Previous studies on CLAC that included preterm infants on non invasive respiratory support showed promising results but they were of short duration. In addition, they did not report on the effect of CLAC on longer term outcomes. These limitations highlighted the need for an adequately powered randomised controlled trial (RCT) of CLAC versus manual oxygen control in preterm non-ventilated infants and for the whole duration of non-invasive respiratory support.

This study's hypothesis is that the use of CLAC in preterm infants < 34 weeks of gestation receiving non-invasive respiratory support will reduce the duration of non-invasive ventilation (NIV). The investigators will also evaluate the time spent within oxygen saturation targets, the incidences of hypoxemia and hyperoxemia, the number of manual adjustments required by clinical staff, the total duration of supplemental oxygen treatment, the length of neonatal unit stay and the incidence of BPD at 36 weeks postmenstrual age (PMA).

This is a single centre, non-blinded, randomised controlled trial in preterm infants born at less than 34 weeks of gestation requiring non-invasive respiratory support at any postnatal age.

The investigators aim to recruit a minimum of 76 preterm infants (39 in each group) and over 12 months.

Informed written consent will be requested from the parents or legal guardians of the infants.

Eligible infants whose parents' consent to the study will be enrolled within 48 hours of initiation of non-invasive respiratory support. Infants who have not been eligible for recruitment within 48 hours of initiation of non-invasive support (for example outborn infants transferred to our unit at a later date) but who remain on it on day seven of life and beyond, they will be enrolled to the study immediately after obtaining parental consent and if less than fourteen days old.

Randomisation will be performed using an online randomisation generator. Patients will be receiving non-invasive support using SLE6000 ventilators or SLE6000N non-invasive respiratory device. Non-invasive support will include nasal continuous positive airway pressure (CPAP), non-invasive positive pressure ventilation (NIPPV) or humidified high flow nasal cannula oxygen (HHFNC). Settings will be manually adjusted by the clinical team as per unit's protocol. All participants will be connected to the standard bedside monitor (Philips IntelliVue MX750) that uses the Nellcor Neonatal SpO2 sensor. The intervention group, in addition to standard care will be also connected to the OxyGenie closed-loop oxygen saturation monitoring software (Inspiration Healthcare, Croydon, UK). Manual adjustments including the percentage of FiO2 will be allowed at any point during the study if deemed appropriate by the clinical team.

The nurse-to-patient ratio will be according to the unit's protocol that is determined on the patient's acuity.

Patients will be studied from enrolment until weaning of non-invasive ventilation or 36 weeks PMA or discharge. If an infant is weaned to low flow nasal cannula oxygen or room air and subsequently requires resuming non-invasive ventilation, they will be studied in their initial arm if less than 36 weeks PMA. Therefore, for those infants randomised at the intervention group CLAC will resume. Preterm infants that remain on non-invasive respiratory support beyond 36 weeks PMA will continue at their study arm (CLAC or manual oxygen control) till their first weaning attempt.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Automated oxygen control
Automated oxygen titration
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.
No Intervention: Manual oxygen control
Manual oxygen titration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The length of non-invasive ventilation
Time Frame: Through study completion, up to 36 weeks post menstrual age
Number of days participant receives non-invasive ventilation
Through study completion, up to 36 weeks post menstrual age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in the time spent within oxygen saturation targets
Time Frame: Through study completion, up to 36 weeks post menstrual age
Percentage of time with oxygen saturation levels between 91-95%.
Through study completion, up to 36 weeks post menstrual age
The change in the time spent in hypoxia (SpO2<80%)
Time Frame: Through study completion, up to 36 weeks post menstrual age
Percentage of time with oxygen saturation levels below 80%
Through study completion, up to 36 weeks post menstrual age
The change in the time spent in hyperoxia
Time Frame: Through study completion, up to 36 weeks post menstrual age
Percentage of time with oxygen saturation levels above 98%.
Through study completion, up to 36 weeks post menstrual age
The change in the number of manual adjustments required
Time Frame: Through study completion, up to 36 weeks post menstrual age
Absolute difference in number of manual FiO2 adjustments
Through study completion, up to 36 weeks post menstrual age
The change in the duration of supplemental oxygen treatment
Time Frame: Through study completion, up to 36 weeks post menstrual age
Number of days infants received supplemental oxygen
Through study completion, up to 36 weeks post menstrual age
The change in the length of neonatal unit stay
Time Frame: Through study completion, up to 36 weeks post menstrual age
Number of days spent in neonatal unit
Through study completion, up to 36 weeks post menstrual age
The change in the incidence of BPD at 36 weeks postmenstrual age
Time Frame: Through study completion, up to 36 weeks post menstrual age
The number of diagnosed cases of BPD among participants
Through study completion, up to 36 weeks post menstrual age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Investigators

  • Principal Investigator: Ourania Kaltsogianni, King's College Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 366356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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