GentleFit Non-Invasive Ventilation (NIV) Interface Trial

Pilot of New GentleFit NIV Interfaces for Size and Fit With Pediatric Patients

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.

Study Overview

• Status: Terminated
• Conditions: Device Ineffective; Device Induced Injury
• Intervention / Treatment: Device: 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
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• 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.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Children requiring Non-Invasive Ventilation (NIV); Children with corrected gestational age ≥ 38 weeks through 3 years old weighing > 3.5kg requiring NIV.

Device: GentleFit Mask, GentleFit Prong, Standard of Care Interface; The subject will be randomized to sequence of interfaces. The subject will wear each of three NIV interfaces for 8 cumulative hours, for a total of 24 hours. Pressure achieved using each GentleFit interface will be compared to pressure achieved by standard of care interface. In the event either the GentleFit nasal mask or nasal prong does not appropriately fit the subject, a standard of care interface will be substituted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure delivered by GentleFit Nasal Mask	To compare pressure achieved by GentleFit Non-invasive Ventilation (NIV) nasal mask compared to standard of care interface. Set Peak End Expiratory Pressure (PEEP) and Peak Inspiratory Pressure (PIP) settings and delivered PEEP, PIP and Mean Airway Pressure (MAP) will be monitored over 24 hours. Data collected from the ventilator on each interface, will be compared to the same values with standard of care interface.	24 hours
Pressure delivered by GentleFit Nasal Prongs	To compare pressure achieved by GentleFit NIV nasal prong compared to standard of care interface. Set PEEP and PIP settings and delivered PEEP, PIP and Mean Airway Pressure (MAP) will be monitored over 24 hours. Data collected from the ventilator on each interface, will be compared to the same values with standard of care interface.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Integrity	To monitor skin integrity in compliance with Respiratory Care Procedure "Non- Invasive Ventilation Interface Skin Assessment". Skin assessments will be conducted per hospital policy as standard of care and be monitored over 24 hours. When a pressure injury is present, clinicians will use a pressure injury staging system from the National Pressure Injury Advisory Panel (NPIAP) to grade severity of skin injury when indicated. Pressure injuries will be numerically staged ( Stage 1, 2, 3 or 4), if the type of tissue injured can be visualized or directly palpated. If the wound base cannot be evaluated, classify as: a) Deep Tissue Pressure Injury (DTPI) b) Unstageable. If on a mucosal membrane, document, but do not stage. The numerical staging system does NOT imply linear progression of pressure injuries from Stage 1 through Stage 4, nor does it imply healing from Stage 4 through Stage 1.	24 hours
Usability - Ease of Use	To evaluate clinician opinion of ease of use of GentleFit NIV interfaces and headgear in pediatric subjects. Clinicians will complete a 5 question REDCap survey on GentleFit NIV interfaces compared to standard of care interfaces the subject is using. The clinician will rate ease of use on a scale of 1-5 with 1 rating as difficult, up to 5 being easiest over 24 hours. Comment sections are provided for free text.	24 hours
Usability - Overall Fit	To evaluate clinician opinion of the overall fit GentleFit NIV interfaces and headgear in pediatric subjects. Clinicians will complete a 5 question REDCap survey on GentleFit NIV interfaces compared to standard of care interfaces the subject is using. The clinician will evaluate the overall fit and appropriate of size of headgear and interfaces with yes/no questions over 24 hours. Comment sections are provided for free text.	24 hours
Clinical Parameters - Vital Sign - Oxygen Saturation	To monitor and record Oxygen Saturation (SpO2), per non-invasive ventilation standard of care, over 24 hours.	24 hours
Clinical Parameters - Vital Sign - Respiratory Rate	To monitor and record Respiratory Rate (RR), per non-invasive ventilation standard of care, over 24 hours.	24 hours
Clinical Parameters - Vital Sign - Heart Rate	To monitor and record Heart Rate (HR), per non-invasive ventilation standard of care, over 24 hours.	24 hours
Clinical Parameters - Vital Sign - Transcutaneous Carbon Dioxide	To monitor and record Transcutaneous Carbon Dioxide (TcPCO2) when applicable, over 24 hours.	24 hours
Clinical Parameters - Ventilator Values	Accurate fit is assessed by ensuring that the ventilator pressures set are delivered with accuracy while preventing skin breakdown due to inaccurate fit. Ordered verses measured ventilator settings will be recorded over 24 hours.	24 hours
Occurrence of Adverse Events	Presence or increased frequency/severity of events that would necessitate discontinuation of an interface. The frequencies of Adverse Events (AE)s by type, body system, severity, and relationship to study interface will be summarized over 24 hours. AE incidence will be summarized along with the corresponding exact binomial 95% two-sided confidence intervals.	24 hours

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Natalie Napolitano, PhD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2025
• Primary Completion (Actual): January 20, 2026
• Study Completion (Actual): January 20, 2026

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 23-021144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No