GentleFit Non-Invasive Ventilation (NIV) Interface Trial

NCT06833294 | Terminated FDA Device

• 1 other identifier: 23-021144
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Device Ineffective; Device Induced Injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Skin Integrity

  24 hours

• Usability - Ease of Use

  24 hours

• Usability - Overall Fit

  24 hours

• Clinical Parameters - Vital Sign - Oxygen Saturation

  24 hours

• Clinical Parameters - Vital Sign - Respiratory Rate

  24 hours

Study Arms (1)

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

Interventions

GentleFit Mask, GentleFit Prong, Standard of Care Interface DEVICE

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.

Children requiring Non-Invasive Ventilation (NIV)

Eligibility Criteria

• Age: 38 Weeks - 3 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Natalie Napolitano, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 18, 2025
• Study Start: October 24, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)