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Breathing battle: which CPAP is best for tiny lungs?

NCT ID NCT07513051

Knowledge-focused Sponsor: Centre Hospitalier Intercommunal Creteil 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two types of CPAP machines that help premature babies breathe. One delivers a constant flow of air, the other a variable flow. Researchers will measure the babies' diaphragm activity to see if constant flow works just as well. The study involves 20 infants born at or before 32 weeks.

What this could mean

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

Active substance
Constant Flow CPAP and Variable Flow CPAP devices
What this could lead to
If constant flow CPAP works as well as variable flow, it could offer a simpler, cheaper option for helping premature babies breathe.
What could go wrong
This is a very small, early study with only 20 babies. It measures breathing effort, not long-term health outcomes, so results may not change practice.

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 20 people

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

Started

Jun 2026

Expected to finish

Dec 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

72 hours to 10 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.

Above mentioned age limits (72 hours to 10 weeks) apply to postnatal age. Inclusion criteria apply to gestational age at birth and postmenstrual age (in weeks). Inclusion Criteria: * Neonates born at ≤ 32 weeks GA (gestational age) * Hospitalized in our tertiary hospital NICU (Neonatal intensive care unit) * Receiving CPAP since \> 24 hours at inclusion * Equipped with EAdi catheters. * Aged more than 72 hours * With parental consent * Affiliated to or benefiting from a social security system Non inclusion Criteria: * More than 1 episode of apnea / hour and/or hypercapnic acidosis (defined as pH \< 7.20 and/or pCO2 \> 65) * FiO2 \> 60% * Neonatal ARDS (acute respiratory distress syndrome) according to the Montreux definition * Pneumothorax/ pneumomediastinum * Nasal lesions contraindicating nasal noninvasive ventilation * Major congenital malformation/Chromosomopathies * Congenital neuromuscular diseases * Hemodynamic instability

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Conditions

The condition(s) this trial relates to.

newborn respiratory distress syndrome Pulmonary Atelectasis

As listed by the trial registrant

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

Neonatal respiratory distress

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

  • Centre Hospitalier Intercommunal de Créteil

    RECRUITING

    Créteil, 94000, France

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