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Smart oxygen device may protect tiny lungs in preterm babies

NCT ID NCT06622161

Symptom relief Sponsor: Aga Khan University Hospital, Pakistan Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether an automated oxygen control device (Oxygenie) could keep preterm babies' oxygen levels in a safer range better than manual adjustments by nurses. 26 preterm babies on ventilators were randomly assigned to 12 hours of automated or manual oxygen control, then switched. The main goal was to see how much time their oxygen levels stayed within the target range of 90-94%.

What this could mean

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

Active substance
Oxygenie automated oxygen control device
What this could lead to
If it works, this could help preterm babies avoid dangerous oxygen swings, reducing risks of eye and lung problems.
What could go wrong
This is a small, completed crossover study with only 26 babies, so results may not apply to all preterm infants. The device may not work as well in real-world settings.

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

26 people

The number who actually took part.

Started

Oct 2024

Finished

Aug 2025

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

Up to 13 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: Investigators will include premature babies (born before 37 weeks of pregnancy) who are on SLE 6000 ventilator, and require additional oxygen therapy or respiratory support due to respiratory dysfunction. Preterm babies will be included in the study if they will meet all the following criteria: * Receiving respiratory support via mechanical ventilation, either non-invasive or invasive * Receiving supplemental oxygen at the time of inclusion * Written informed parental consent Exclusion Criteria: * Major Congenital Anomalies such as neural tube defects, neuromuscular disorders, congenital heart diseases, syndromic babies, and so forth. * Resuscitation and termination of mechanical ventilation during the study * Withdrawal of parent consent

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Conditions

The condition(s) this trial relates to.

Hyperoxia Hypoxia Premature Birth

As listed by the trial registrant

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

Preterm

Contacts and locations

Locations

  • Aga Khan University Hospital

    Karachi, Sindh, 74800, Pakistan

More trials for these conditions

Other studies related to the condition(s) this trial covers.