Device IneffectiveNCT06833294
GentleFit Non-Invasive Ventilation (NIV) Interface Trial
An observational study of Device Ineffective and Device Induced Injury, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 38 weeks to 3 years
- Conditions the study is for
- Device Ineffective, Device Induced Injury
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2025to 20 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 weeks to 3 years
- All sexes
- Child
Study population: Children with corrected gestational age ≥ 38 weeks through 3 years old weighing > 3.5kg, requiring respiratory support via NIV.
Who may be able to join
- 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).
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Device Ineffective, Device Induced Injury
- Being tested
- GentleFit Mask, GentleFit Prong, Standard of Care Interface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentleFit Mask, GentleFit Prong, Standard of Care InterfaceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Children requiring Non-Invasive Ventilation (NIV) | Children with corrected gestational age ≥ 38 weeks through 3 years old weighing > 3.5kg requiring NIV. Receives: Device: GentleFit Mask, GentleFit Prong, Standard of Care Interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 hours
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours
Clinical Parameters - Vital Sign - Transcutaneous Carbon Dioxide
To monitor and record Transcutaneous Carbon Dioxide (TcPCO2) when applicable, over 24 hours.
Measured: 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.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start24 Oct 2025
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Why it stopped: The study was terminated due to feasibility challenges related to device compatibility with the intended patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device IneffectiveStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie Napolitano, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833294
- Sponsor's protocol ID
- 23-021144
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of New GentleFit NIV Interfaces for Size and Fit With Pediatric Patients
- ClinicalTrials.gov ID
- NCT06833294
- Acronym / sponsor ID
- 23-021144
- Conditions
- Device Ineffective, Device Induced Injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated due to feasibility challenges related to device compatibility with the intended patient population.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children requiring Non-Invasive Ventilation (NIV) | – | Device: GentleFit Mask, GentleFit Prong, Standard of Care InterfaceChildren with corrected gestational age ≥ 38 weeks through 3 years old weighing > 3.5kg requiring NIV. |
Who may qualify
- Ages
- 38 weeks to 3 years
- Sex
- All
- Age groups
- Child
- Study population
- Children with corrected gestational age ≥ 38 weeks through 3 years old weighing > 3.5kg, requiring respiratory support via NIV.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GentleFit Mask, GentleFit Prong, Standard of Care InterfaceThe 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. | Device | Children requiring Non-Invasive Ventilation (NIV) |
Primary outcome
Pressure delivered by GentleFit Nasal Mask
Time frame: 24 hours
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.
Pressure delivered by GentleFit Nasal Prongs
Time frame: 24 hours
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.
9 secondary outcomes
Skin Integrity
Time frame: 24 hours
Usability - Ease of Use
Time frame: 24 hours
Usability - Overall Fit
Time frame: 24 hours
Clinical Parameters - Vital Sign - Oxygen Saturation
Time frame: 24 hours
Clinical Parameters - Vital Sign - Respiratory Rate
Time frame: 24 hours
Clinical Parameters - Vital Sign - Heart Rate
Time frame: 24 hours
Clinical Parameters - Vital Sign - Transcutaneous Carbon Dioxide
Time frame: 24 hours
Clinical Parameters - Ventilator Values
Time frame: 24 hours
Occurrence of Adverse Events
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: The study was terminated due to feasibility challenges related to device compatibility with the intended patient population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Napolitano, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Device Ineffective and Device Induced Injury, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to feasibility challenges related to device compatibility with the intended patient population.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure delivered by GentleFit Nasal Mask (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.