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Tiny noses, big difference: study tests CPAP masks to prevent pressure sores in preemies

NCT ID NCT07521410

Symptom relief Sponsor: Istanbul University - Cerrahpasa 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares three types of CPAP masks (binasal prong, nasal cannula, and nasal mask) to see which causes fewer nasal pressure injuries in preterm infants. 75 babies in the NICU will be randomly assigned to one mask type and monitored for 4 days. The goal is to find the gentlest interface to protect delicate skin.

What this could mean

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

Active substance
Continuous positive airway pressure (CPAP) delivered via binasal prong, nasal cannula, or nasal mask
What this could lead to
If one interface works better, it could reduce painful nasal injuries in preterm babies on breathing support.
What could go wrong
This is a small, early-stage study (75 infants) that only looks at short-term skin effects, not long-term outcomes. Results may not apply to all preterm infants.

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 75 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

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

0 minutes to 28 days

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 with a gestational age between 28 and 37 weeks * Receiving non-invasive ventilation support in a neonatal intensive care unit * Receiving non-invasive ventilation for at least 4 days * Parental consent obtained Exclusion Criteria: * Infants requiring intubation * Presence of congenital anomalies * Pre-existing nasal injury or trauma * Presence of skin disease * Nasal lesions due to previous nasotracheal intubation * Upper airway malformations * Infants transferred from another center after receiving more than 24 hours of non-invasive ventilation

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Conditions

The condition(s) this trial relates to.

decubitus ulcer Premature Birth

As listed by the trial registrant

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

Medical device-related pressure injury Prematurity

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

  • Tekirdag Ismail Fehmi Cumalioglu City Hospital, Neonatal Intensive Care Unit

    Tekirdağ, Turkey (Türkiye)

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