Pediatric Mask Fit Study

NCT05942534 | Completed

• 1 other identifier: 1000080453
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mask and respirator comfort and acceptability

  First visit (1 hour)

Study Arms (2)

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.

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children ages 4 to 17 years able to wear a mask

You may qualify if:

• Aged 4-17
• able to tolerate wearing a mask

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 12, 2023
• Study Start: July 5, 2023
• Primary Completion: October 29, 2023
• Study Completion: October 29, 2023
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)