GentleFit Non-Invasive Ventilation (NIV) Interface Trial

Stopped early

Conditions studied: Device Ineffective, Device Induced Injury

In brief

The primary objective is to compare pressure achieved by GentleFit Non-Invasive Ventilation (NIV) nasal mask and nasal prong to standard of care interface. Secondary objectives include to monitor skin integrity, clinical parameters, and adverse events. Additionally, to evaluate clinician opinion of ease of application and overall fit of GentleFit NIV interfaces and headgear.

Key facts

Study ID

NCT06833294

Run by

Children's Hospital of Philadelphia

People needed

4

Starts

2025-10-24

Expected to finish

2026-01-20

Last updated by the study team

2026-02-09

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children with corrected gestational age ≥ 38 weeks through 3 years old weighing > 3.5kg.
• Children who are on clinically stable Non-Invasive Ventilation (NIV) settings, defined as no escalation in support in the last 6-8 hours.
• Children whose nares, face, or head fit at least one of the GentleFit NIV interfaces.
• Parental/guardian permission (informed consent).

You may not qualify if…

• Children whose nares, face, or head do not fit the manufacturer sizing guide for nasal mask and nasal prongs.
• Facial anomalies (e.g. cleft lip).
• Existing skin injury present in an area where GentleFit NIV interfaces or headgear would contact skin.
• Patient's emergent condition.

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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