NCT03788330

Brief Summary

A randomized crossover trial will be conducted in 90 primary school children in 3 classrooms in Shanghai, China. The effects of fresh air ventilation/filtration system, fresh air ventilation system with no filtration and natual ventilation will be compared on the effects of reducing indoor PM2.5 and chilhood health. Biological samples of children are going to be collected to investigate the associations between indoor air pollution and biomarkes of certain health effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

December 7, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 27, 2018

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2019

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

1 month

First QC Date

December 5, 2018

Last Update Submit

March 28, 2019

Conditions

Keywords

exhaled nitric oxideSick building syndromeindoor air

Outcome Measures

Primary Outcomes (3)

  • Exhaled nitric oxide

    Airway inflammation biomarker

    within 2 hours of the end of intervention in each week

  • Oxidative stress biomarkers

    The level of lysozyme, cortisone and SIgA will be assessed in saliva and other oxidative biomarkers in the urine samples in children.

    within 2 hours of the end of intervention in each week

  • Sick building symdrom

    Answering questionnaire on sick biulding symdrom

    within 2 hours of the end of intervention in each week

Study Arms (3)

Fresh air system with filtration

EXPERIMENTAL

A fresh air ventilation system combined with PM2.5 filtration is applied in one primary school classroom.

Device: Fresh air system with filtration

Fresh air system with no filtration

PLACEBO COMPARATOR

A fresh air ventilation system with no PM2.5 filtration is applied in a parallel classroom.

Device: Fresh air system with filtration

Natural ventilation

NO INTERVENTION

Natural ventilation system was applied in the 3rd classroom as normal.

Interventions

Using fresh air ventilation combined with PM2.5 filtration system to reduce the indoor PM2.5 concentration in primarty school classrooms

Also known as: mechanical ventilation and filtration system
Fresh air system with filtrationFresh air system with no filtration

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All invited primary school children in Grade 5 in an artibrarily selected school

You may not qualify if:

  • Current airway symptoms (cough, airway infection, asthma et al.)
  • Acute infectious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Cognition DisordersSick Building Syndrome

Interventions

FiltrationRespiration, Artificial

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersEnvironmental IllnessHypersensitivityImmune System DiseasesDisorders of Environmental Origin

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative TechniquesPhysical PhenomenaChemical PhenomenaAirway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Zhuohui Zhao, Dr

    Fudan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigation director

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 27, 2018

Study Start

December 7, 2018

Primary Completion

January 20, 2019

Study Completion

January 22, 2019

Last Updated

March 29, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations