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Smart oxygen monitoring could help preterm babies breathe easier

NCT ID NCT07161908

Disease control Sponsor: Institute of Health Information and Statistics of the Czech Republic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a remote monitoring system using pulse oximeters to optimize oxygen therapy in premature infants with bronchopulmonary dysplasia (BPD). Researchers aim to reduce the time babies need oxygen and prevent complications like pulmonary hypertension. The trial involves 70 infants born before 32 weeks, and parents will adjust oxygen flow at home based on saturation readings.

What this could mean

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

Active substance
pulse oximeter (device)
What this could lead to
If successful, this could establish a standard method for safely weaning preterm infants off oxygen therapy, reducing lung damage and improving long-term health.
What could go wrong
This is a small pilot study with only 70 infants, so results may not apply broadly. The device itself does not treat the disease, and oxygen adjustments carry risks of hypoxia or over-oxygenation.

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 70 people

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

Started

Aug 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

Up to 36 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: * infants born before 31+6 weeks gestation * signed consent for participation in the project and consent for the processing of personal data * diagnosed with bronchopulmonary dysplasia * type of pulmonary ventilation - low-flow nasal cannulas Exclusion Criteria: * unsigned consent for participation in the project and/or consent for the processing of personal data * child diagnosed with conditions other than bronchopulmonary dysplasia (BPD) at high risk of long-term hypoxia - selected chronic cardiovascular, neurological, and muscular diseases, e.g., significant congenital heart defects, congenital central nervous system developmental disorders, genetic diseases associated with the risk of hypoventilation, central apneas, severe early obstructive sleep apnea * other chronic respiratory diseases besides BPD - e.g., cystic fibrosis, chronic aspiration * insufficient therapy through long-term home oxygen therapy * tracheostomy

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia pulmonary hypertension

As listed by the trial registrant

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

BPD - bronchopulmonary dysplasia Pulmonary hypertension

How to take part

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

  1. The places running it

    4 sites. 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

  • General University Hospital

    RECRUITING

    Prague, Czech Republic, Czechia

  • Institute for the Care of Mother and Child

    RECRUITING

    Prague, Czech Republic, Czechia

  • University Hospital Olomouc

    RECRUITING

    Olomouc, Czech Republic, Czechia

  • České Budějovice Hospital

    RECRUITING

    České Budějovice, Czech Republic, Czechia

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