The Health Benefits of Indoor Air Filtration Among Children

NCT ID: NCT04835337

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-10

Study Completion Date

2022-05-15

Brief Summary

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This study aims to explore the health benefits of air purifier on the impact of air pollutants on children's health.

Detailed Description

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From April 2021 to December 2021, researchers conduct a randomized double-blind crossover trial on about 100 healthy children in Jiaozuo City, Henan Province. The children are divided into two groups according to their classes and alternated the use of true or sham purifiers devices, including air purifiers and fresh air ventilation. Air purifiers are installed in the classroom and bedrooms of the children. Fresh air ventilation is installed in the classroom. A total of 4 epidemiological surveys are conducted on the subjects, with an interval of 60 days or more. All participants and research staffs were blinded to the group assignment. In addition, air pollutant exposure monitoring, questionnaire surveys, physical examinations, and biological sample collection are conducted on the research subjects each time. The biological samples are further tested for the concentration levels of related biomarkers such as the respiratory system, cardiovascular system, metabolic system, and nervous system. Furthermore, comprehensive evaluation of children's behavioral ability is also carried out. Ambient PM2.5 and indoor PM2.5 exposure concentrations are monitored in the study.

Conditions

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Protective Effect of Air Purifier on Children's Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Air purifier

Participants in this group receive an intervention of real air purifiers placed in the indoor environment.

Group Type EXPERIMENTAL

Air Purifiers

Intervention Type BEHAVIORAL

Students are divided into two groups: intervention group and control group. The intervention team places an air purifier in the indoor environment to intervene. All the indoor environment of the group use the same qualified air purifier, and all participants and research staffs are blinded to the group assignment.

Control

Participants in this group receive an intervention of sham air purifiers, we just remove the filter in the purifiers, and the other treatments are the same as the real purification group.

Group Type SHAM_COMPARATOR

Sham Air Purifiers

Intervention Type BEHAVIORAL

The control group is also intervened. The intervention is to place a sham air purifier (remove the filter screen) in the indoor environment, and all the indoor environment use the same air purifier as the intervention group. All participants and research staffs are blinded to the group assignment.

Interventions

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Air Purifiers

Students are divided into two groups: intervention group and control group. The intervention team places an air purifier in the indoor environment to intervene. All the indoor environment of the group use the same qualified air purifier, and all participants and research staffs are blinded to the group assignment.

Intervention Type BEHAVIORAL

Sham Air Purifiers

The control group is also intervened. The intervention is to place a sham air purifier (remove the filter screen) in the indoor environment, and all the indoor environment use the same air purifier as the intervention group. All participants and research staffs are blinded to the group assignment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 10 ≤ 12 years old
* Volunteer to participate in this study

Exclusion Criteria

* Current and past medical history, including asthma, childhood diabetes, childhood hypertension, behavior-related diseases
* Students who plan to transfer or move within six months
* Unable to cooperate with follow-up
Minimum Eligible Age

10 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tiantian Li

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tiantian Li

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tiantian Li

Role: STUDY_DIRECTOR

National Institute of Environmental Health, Chinese Center for Disease Control and Prevention

Locations

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National Institute of Environmental Health, Chinese Center for Disease Control and Prevention

Beijing, , China

Site Status

Countries

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China

References

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Lei J, Sun Q, Chen R, Zhu Y, Zhou L, Xue X, Fang J, Du Y, Wang Y, Li T, Kan H. Respiratory Benefits of Multisetting Air Purification in Children: A Cluster Randomized Crossover Trial. JAMA Pediatr. 2025 Feb 1;179(2):122-128. doi: 10.1001/jamapediatrics.2024.5049.

Reference Type DERIVED
PMID: 39621320 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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202032

Identifier Type: -

Identifier Source: org_study_id

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