TerminatedNot Applicable

GentleFit Non-Invasive Ventilation (NIV) Interface Trial

Stopped: The study was terminated due to feasibility challenges related to device compatibility with the intended patient population.

United States4 participantsStarted 2025-10-24

Plain-language summary

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.

Who can participate

Age range38 Weeks – 3 Years

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

Pressure delivered by GentleFit Nasal Mask

Timeframe: 24 hours

Pressure delivered by GentleFit Nasal Prongs

Timeframe: 24 hours

Trial details

NCT IDNCT06833294

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01-20

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