Pediatric Mask Fit Study

Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942534
• Other study ID #: 1000080453
• Status: Recruiting
• Start date: July 5, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: December 2023
• Source: The Hospital for Sick Children
• Contact: Jenny Wang
• Phone: 4168137654
• Email: jenny.wang1[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Tract Infections

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	First visit (1 hour)
Secondary	Mask and respirator comfort and acceptability	Evaluate the comfort and acceptability of different masks, mask modifications, and respirators as experienced by children	First visit (1 hour)