Effect of Aerosol Filtering on Infectious Diseases in Day... | NCT05569330

Studies
Effect of Aerosol Filtering on Infectious Diseases in Day Care

NCT05569330

Sponsor

Helsinki University Central Hospital

Status

Unknown status

Last Update Posted

May 11, 2023Actual

Enrollment

92Actual

Phase

Not Applicable

Conditions

Upper Respiratory Tract Infection
Diarrhea

Interventions

Air purification

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Actual

Primary Completion Date

Apr 30, 2024Estimated

Completion Date

Apr 30, 2024Estimated

First Submitted Date

Sep 28, 2022

First Submission Date that Met QC Criteria

Oct 3, 2022

First Posted Date

Oct 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2023

Last Update Posted Date

May 11, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ville Vartiainen, MD, PhD, MSc, researhcer, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Effect of aerosol flitration and removal on typical infectious diseases such as upper respiratory tract infectinos is studied in day care. Many filtration methods such as filters and electrical filtering are used to remove aerosol particles from room air.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Other	Two of the four participating day care units are allocated in arm 1	Other: Air purification
Arm 2	Other	Two of the four participating day care units are allocated in arm 2	Other: Air purification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Air purification	Other	Aerosol particles are removed from room air by several methods	Arm 1 Arm 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incident infections	Incident infections among subjects	During the study periods 11/22-4/23 and 11/23-4/24. These are identical for every subject.

Secondary Outcomes

Measure	Description	Time Frame
Days absent from work	Days absent from work by the parents of sick children	During the study periods 11/22-4/23 and 11/23-4/24. These are identical for every subject.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is expected to be in the same day care unit for the duration of the study

Exclusion Criteria:

Subject is known not to be in the same day care unit for the duration of the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ville Vartiainen, MD, PhD	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City of Helsinki Day care		Helsinki			Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012141	Respiratory Tract Infections
D003967	Diarrhea

Ancestor Terms

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided