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NCT06833294 | NOT YET RECRUITING | Device Ineffective

GentleFit Non-Invasive Ventilation (NIV) Interface Trial
Sponsor:

Children's Hospital of Philadelphia

Brief 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.

Condition or disease

Device Ineffective

Device Induced Injury

Intervention/treatment

GentleFit Mask, Gentlefit Prong, Standard of Care Interface

Detailed Description:

Current NIV interfaces commercially available do not address all size and anatomical gaps present in the pediatric population. To overcome this challenge, nasal mask and nasal prong prototype interfaces have been designed to fill some of the current size gap. These interfaces, known as GentleFit NIV, need to be trialed to ensure appropriateness of design and patient tolerance for 4-8 hour application intervals, as is standard of practice for current devices on the market.

Study Type : OBSERVATIONAL
Estimated Enrollment : 48 participants
Official Title : Pilot of New GentleFit NIV Interfaces for Size and Fit With Pediatric Patients
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 38 Weeks to 3 Years
Sexes Eligible for Study: ALL
Criteria
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. 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.
  • -
GentleFit Non-Invasive Ventilation (NIV) Interface Trial

Location Details

NCT06833294

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How to Participate

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Locations

Not yet recruiting

United States, Pennsylvania

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104