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New mask fit study for kids on breathing support

NCT ID NCT06833294

Knowledge-focused Sponsor: Children's Hospital of Philadelphia 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 new GentleFit non-invasive ventilation masks and prongs in children up to 3 years old. Researchers compared how well these interfaces delivered air pressure and monitored skin health over 24 hours. The goal was to see if the new designs fit better and work as well as standard masks.

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.

Participants

4 people

The number who actually took part.

Started

Oct 2025

Finished

Jan 2026

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.

Who is studied

Children with corrected gestational age ≥ 38 weeks through 3 years old weighing \> 3.5kg, requiring respiratory support via NIV.

Ages

38 weeks to 3 years

Sex

Anyone

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: 1. Children with corrected gestational age ≥ 38 weeks through 3 years old weighing \> 3.5kg. 2. Children who are on clinically stable Non-Invasive Ventilation (NIV) settings, defined as no escalation in support in the last 6-8 hours. 3. Children whose nares, face, or head fit at least one of the GentleFit NIV interfaces. 4. Parental/guardian permission (informed consent). Exclusion Criteria: 1. Children whose nares, face, or head do not fit the manufacturer sizing guide for nasal mask and nasal prongs. 2. Facial anomalies (e.g. cleft lip). 3. Existing skin injury present in an area where GentleFit NIV interfaces or headgear would contact skin. 4. Patient's emergent condition. \-

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Conditions

The condition(s) this trial relates to.

injury

As listed by the trial registrant

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

Device induced injury Device ineffective

Contacts and locations

Locations

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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