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Can a simple color change improve breathing support for preemies?

NCT ID NCT07754032

Disease control Sponsor: Leiden University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether using a colorimetric carbon dioxide (CO₂) detector to guide non-invasive breathing support (ventilation) improves care for premature infants born before 32 weeks. The detector changes color to show how well the baby is exhaling CO₂, which may help doctors adjust support more accurately. The study will compare this approach to standard care in over 1,800 infants across multiple centers, looking at how quickly breathing support is adjusted and whether it reduces the need for more intensive interventions.

What this could mean

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

Active substance
Colorimetric carbon dioxide (CO₂) detector-guided non-invasive ventilation
What this could lead to
If effective, this simple, low-cost tool could help doctors adjust breathing support more precisely, potentially reducing the need for more invasive procedures and improving outcomes for premature infants.
What could go wrong
This is a large trial, but the intervention involves a behavioral change in how clinicians respond to the detector, which may vary. The benefit over standard care is not yet proven, and there is always a risk that the detector may not improve outcomes as hoped.

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 1,860 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Mar 2028

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

Up to 32 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: * Born before 32 weeks of gestation * Received non-humidified face-mask support in the first 10 minutes of life * Parental consent obtained Exclusion Criteria: * Congenital diaphragmatic hernia * Tracheo-oesophageal fistula * Cyanotic heart disease * Surfactant protein deficiency * Any other congenital abnormality or condition with an adverse effect on breathing, ventilation, or oxygenation. Many of the infants enrolled in the study will later be diagnosed with respiratory distress syndrome (RDS); this will not render them ineligible for inclusion.

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Conditions

The condition(s) this trial relates to.

Hyaline Membrane Disease Infant, Premature, Diseases neonatal respiratory failure newborn respiratory distress syndrome Premature Birth

As listed by the trial registrant

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

Birth, preterm Infant, premature, diseases Respiratory distress neonatal

How to take part

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

  1. 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 ↗

  2. 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.

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