Respiratory Tract InfectionsNCT05942534
Pediatric Mask Fit Study
An observational study of Respiratory Tract Infections, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This study will evaluate the performance of various face masks and respirators on children by examining their fitted filtration efficiency (FFE) and mask fit. It will also evaluate the impact of different types of mask modifications (for example, twisting the ear loops, tuck and tie) on FFE and mask fit, with the goal… Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jul 2023to 29 Oct 2023
- 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 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children ages 4 to 17 years able to wear a mask
Who may be able to join
- Aged 4-17
- able to tolerate wearing a mask
Who cannot join
- Children will be excluded if they have contraindications to wearing a mask.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Mask Fit Study: Comparing the Performance of Cloth Masks, Procedure Masks With and Without Modifications and Respirators in Children
This study will evaluate the performance of various face masks and respirators on children by examining their fitted filtration efficiency (FFE) and mask fit. It will also evaluate the impact of different types of mask modifications (for example, twisting the ear loops, tuck and tie) on FFE and mask fit, with the goal of determining how to optimize mask performance in children. It will also provide information on mask and respirator comfort and acceptability. This data will help inform public health messaging around mask choice for children and also modifications that can be made to improve fit for children who may not have access to various mask types.
Read the detailed description
This will be a prospective cross-sectional study of 200 children aged 4 to 17 years. Participants will be assigned to either the mask type assessment (Objective 1) or the mask modification assessment (Objective 2) and have a date and time scheduled for testing.
The mask type assessment will compare the FFE and fit factor of a cloth mask, child and adult medical mask, child and adult KN95 respirator, and N95 respirator. The mask modification assessment will compare the FFE and fit factor of a child medical mask, adult medical mask with and without modifications (tuck and tie, twisted ear loops), and child and adult N95 respirator. Quantitative fit testing will be conducted using a TSI Portacount Pro Respirator Fit Tester model 8038+. Testing will be performed in an identified designated area at the hospital or in the community (i.e., schools or community center), monitored for ventilation, temperature and humidity. We will also measure the ambient particles to ensure adequate particle count. The participants will be asked to evaluate the mask, respirator or modification based on a variety of criteria including comfort, breathability and acceptability. This will be completed immediately after the fit assessment.
- Conditions
- Respiratory Tract Infections
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mask type assessment | The mask type assessment will compare a cloth mask, child and adult medical mask, child and adult KN95 respirator, and N95 respirator. | |
| mask modification assessment | The mask modification assessment will compare a child medical mask, adult medical mask with and without modifications (tuck and tie, twisted ear loops), and child and adult N95 respirator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitter filtration efficiency and fit factor
To compare the performance of different mask (cloth and medical) and respirator (KN95 and N95) types and mask modifications in children, as measured by fitted filtration efficiency (FFE) and fit factor.
Measured: First visit (1 hour)
Secondary outcomes (1)
Mask and respirator comfort and acceptability
Evaluate the comfort and acceptability of different masks, mask modifications, and respirators as experienced by children
Measured: First visit (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start5 Jul 2023
- Primary completion29 Oct 2023
- Study completion29 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Science, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942534
- Sponsor's protocol ID
- 1000080453
- Status last verified
- Feb 2025
- First submitted
- 16 Jun 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Mask Fit Study: Comparing the Performance of Cloth Masks, Procedure Masks With and Without Modifications and Respirators in Children
- ClinicalTrials.gov ID
- NCT05942534
- Acronym / sponsor ID
- 1000080453
- Conditions
- Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 29 Oct 2023 (actual)
- Study completion
- 29 Oct 2023 (actual)
- First posted
- 12 Jul 2023 (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.
This study will evaluate the performance of various face masks and respirators on children by examining their fitted filtration efficiency (FFE) and mask fit. It will also evaluate the impact of different types of mask modifications (for example, twisting the ear loops, tuck and tie) on FFE and mask fit, with the goal of determining how to optimize mask performance in children. It will also provide information on mask and respirator comfort and acceptability. This data will help inform public health messaging around mask choice for children and also modifications that can be made to improve fit for children who may not have access to various mask types.
Detailed description
This will be a prospective cross-sectional study of 200 children aged 4 to 17 years. Participants will be assigned to either the mask type assessment (Objective 1) or the mask modification assessment (Objective 2) and have a date and time scheduled for testing.
The mask type assessment will compare the FFE and fit factor of a cloth mask, child and adult medical mask, child and adult KN95 respirator, and N95 respirator. The mask modification assessment will compare the FFE and fit factor of a child medical mask, adult medical mask with and without modifications (tuck and tie, twisted ear loops), and child and adult N95 respirator. Quantitative fit testing will be conducted using a TSI Portacount Pro Respirator Fit Tester model 8038+. Testing will be performed in an identified designated area at the hospital or in the community (i.e., schools or community center), monitored for ventilation, temperature and humidity. We will also measure the ambient particles to ensure adequate particle count. The participants will be asked to evaluate the mask, respirator or modification based on a variety of criteria including comfort, breathability and acceptability. This will be completed immediately after the fit assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mask type assessment | – | –The mask type assessment will compare a cloth mask, child and adult medical mask, child and adult KN95 respirator, and N95 respirator. |
| mask modification assessment | – | –The mask modification assessment will compare a child medical mask, adult medical mask with and without modifications (tuck and tie, twisted ear loops), and child and adult N95 respirator. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children ages 4 to 17 years able to wear a mask
Key inclusion criteria (2 listed)
- Aged 4-17
- able to tolerate wearing a mask
Key exclusion criteria (1 listed)
- Children will be excluded if they have contraindications to wearing a mask.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fitter filtration efficiency and fit factor
Time frame: First visit (1 hour)
To compare the performance of different mask (cloth and medical) and respirator (KN95 and N95) types and mask modifications in children, as measured by fitted filtration efficiency (FFE) and fit factor.
1 secondary outcome
Mask and respirator comfort and acceptability
Time frame: First visit (1 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Respiratory Tract Infections, run by The Hospital for Sick Children at 1 site in Canada.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Feb 2025. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fitter filtration efficiency and fit factor (time frame: First visit (1 hour)). 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 24 Feb 2025.