Pediatric Mask Fit Study

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.

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Key information

Conditions

Respiratory Tract Infections Infections Respiratory Tract Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 4-17
able to tolerate wearing a mask

Exclusion criteria

Children will be excluded if they have contraindications to wearing a mask.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Mask and respirator comfort and acceptability

Time frame: First visit (1 hour)

Evaluate the comfort and acceptability of different masks, mask modifications, and respirators as experienced by children

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Pediatric Mask Fit Study: Comparing the Performance of Cloth Masks, Procedure Masks With and Without Modifications and Respirators in Children

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jul 12, 2023
Registry last updated: Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed