An observational study in Respiratory Tract Infections, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 4 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by The Hospital for Sick Children · Observational
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.
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.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 102 is below the median of 300 across 295 observational studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children ages 4 to 17 years able to wear a mask
Exclusion Criteria:
The mask type assessment will compare a cloth mask, child and adult medical mask, child and adult KN95 respirator, and N95 respirator.
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.
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.
Time frame: First visit (1 hour)
Mask and respirator comfort and acceptability
Evaluate the comfort and acceptability of different masks, mask modifications, and respirators as experienced by children
Time frame: First visit (1 hour)
Plan to share: No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children