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GentleFit Non-Invasive Ventilation (NIV) Interface Trial

NCT ID: NCT06833294

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-24

Study Completion Date

2026-10-30

Brief Summary

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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

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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.

Conditions

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Device Ineffective Device Induced Injury

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Children requiring Non-Invasive Ventilation (NIV)

Children with corrected gestational age ≥ 38 weeks through 3 years old weighing \> 3.5kg requiring NIV.

GentleFit Mask, GentleFit Prong, Standard of Care Interface

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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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Minimum Eligible Age

38 Weeks

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Napolitano, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica Potterton

Role: CONTACT

Phone: 267-425-5483

Email: [email protected]

Amanda Nickel

Role: CONTACT

Phone: 267-425-5483

Email: [email protected]

Facility Contacts

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Jessica Potterton

Role: primary

Other Identifiers

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23-021144

Identifier Type: -

Identifier Source: org_study_id