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Smart oxygen device could help preterm babies breathe easier

NCT ID NCT07622563

Disease control Sponsor: King's College Hospital NHS Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This study tests a closed-loop automated oxygen control device in 76 preterm infants born before 34 weeks who need breathing support. The device automatically adjusts oxygen levels to keep them in a safe range, aiming to reduce the time babies need extra oxygen and lower the risk of lung problems. Researchers will compare outcomes with standard manual oxygen adjustments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OxyGenie closed-loop automated oxygen control device
What this could lead to
If successful, this device could help preterm infants spend more time with safe oxygen levels, potentially reducing lung damage and time on breathing support.
What could go wrong
This is a small, early-stage trial with only 76 infants, so results may not apply widely. The device may not outperform manual control, and technical issues could arise.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 34 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Airway morbidity Infant Premature

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, SE5 9RS, United Kingdom

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