Clinical trial NCT06833294: GentleFit Non-Invasive Ventilation (NIV) Interface Trial
Official title: Pilot of New GentleFit NIV Interfaces for Size and Fit With Pediatric Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Device Ineffective
Device Induced Injury
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 48
Sex: ALL
Minimum age (years): 38
Maximum age (years): 3
Standard ages: CHILD
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with corrected gestational age ≥ 38 weeks through 3 years old weighing \> 3.5kg, requiring respiratory support via NIV.

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.

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.

Eligibility 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.

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Primary outcomes:
measure: Pressure delivered by GentleFit Nasal Mask
timeFrame: 24 hours
measure: Pressure delivered by GentleFit Nasal Prongs
timeFrame: 24 hours
Secondary outcomes:
measure: Skin Integrity
timeFrame: 24 hours
measure: Usability - Ease of Use
timeFrame: 24 hours
measure: Usability - Overall Fit
timeFrame: 24 hours
measure: Clinical Parameters - Vital Sign - Oxygen Saturation
timeFrame: 24 hours
measure: Clinical Parameters - Vital Sign - Respiratory Rate
timeFrame: 24 hours
measure: Clinical Parameters - Vital Sign - Heart Rate
timeFrame: 24 hours
measure: Clinical Parameters - Vital Sign - Transcutaneous Carbon Dioxide
timeFrame: 24 hours
measure: Clinical Parameters - Ventilator Values
timeFrame: 24 hours
measure: Occurrence of Adverse Events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Natalie Napolitano, PhD
role: PRINCIPAL_INVESTIGATOR
References: