NCT04518033

Brief Summary

This study will measure the size and quantity of respiratory particle production in children under a variety of conditions, including face coverings/masks and various common activities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

April 3, 2021

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2021

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

20 days

First QC Date

August 12, 2020

Last Update Submit

January 4, 2022

Conditions

Droplet Spread

Outcome Measures

Primary Outcomes (1)

  • Respiratory particle production

    2 hours

Study Arms (1)

Face covering use

EXPERIMENTAL

Participants will be provided various commercially available face coverings

Device: Various commercially available face coverings

Interventions

Various commercially available face coveringsDEVICE

Various commercially available face coverings

Face covering use

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- Age 3 to 17 years

You may not qualify if:

  • Chronic neuromuscular conditions that affect respiration
  • Tracheostomy tube
  • Unable to wear a face mask

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • Peter P Moschovis, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 19, 2020

Study Start

April 3, 2021

Primary Completion

April 23, 2021

Study Completion

April 23, 2021

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)