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Home Air in Agriculture: Pediatric Intervention Trial

Home Air in Agriculture: Pediatric Intervention Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04919915
Acronym
HAPI
Enrollment
71
Registered
2021-06-09
Start date
2015-07-14
Completion date
2019-02-27
Last updated
2021-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in Children

Keywords

Latinx children, agriculture, HEPA air cleaner, home indoor/outdoor sampling, coarse particulate matter, fine particulate matter, endotoxins, antigens, spirometry, exhaled nitric oxide

Brief summary

This study seeks to reduce exposure to asthmagens in the homes of a community of Latino children residing in an area of intense agricultural production in Eastern Washington by testing the effectiveness of an intervention (high efficiency particulate air filter- HEPA portable room air cleaners) plus asthma education to reduce indoor measures of particulate matter, ammonia, improve clinically relevant measures of asthma health, and reduce biomarkers of inflammation.

Detailed description

Over the course of five years, this project's specific aims are as follows: 1. Build on a well-established community based participatory research program to engage community partners in the design, implementation and evaluation of this asthma intervention study. 2. Conduct a year-long intervention study with longitudinal measurement of key asthmagen exposures and health outcome indicators with minimal participant burden. 3. Develop and characterize evaluation metrics for the process, impact and outcomes of this project in achievement of the aims. 4. Promote sustainable public health action via positive and transparent communications about the project to participants, local stakeholders, and state level policy makers through broad-based community outreach.

Interventions

Participants in the intervention group received two HEPA air cleaners per household. They were informed to place the HEPA air cleaners in the child's bedroom and the living room. Field staff provided and discuss how to use the air cleaner which promoted continuous operation of both air cleaners, keeping the child's bedroom door closed, and selected the highest fan speed. Typical use of the HEPA cleaners were questioned during the mid-study and final visits.

Sponsors

National Institute of Environmental Health Sciences (NIEHS)
CollaboratorNIH
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
CollaboratorNIH
The Yakima Valley Farm Workers Clinic
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Eligibility criteria include male and female, poorly controlled asthma, likely to stay in the area over the course of the study, having only one residence, no smokers in the household and residential proximity to dairy operations/crop production (\<400 meters) determined by the telephone screening questionnaire.

Exclusion criteria

* Prior participation in the Asthma Home Visiting Program, not from the northern third of the lower Yakima Valley, well controlled asthma, unlikely to stay in the are over the course of the study, smokers in the household, no residential proximity to dairy operations or crop production, having more than one residence and inability to communicate over the phone.

Design outcomes

Primary

MeasureTime frameDescription
Change in particulate matter 2.5 (PM2.5) concentration1 year (study period)Indoor air sampling for PM2.5 collected over a 14-day period. MicroPEM (RTI International, Research Triangle Park, NC, USA) is turn on and left on for 14 days. Measurements collected at beginning and at 1 year after enrollment.
Change in ammonia (NH3) concentration1 year (study period)Indoor air sampling for NH3 collected over a 14-day period. Ogawa passive sampler (Ogawa USA, Pompano Beach, Fl, USA) is left open for 14 days. Measurements collected at beginning and at 1 year after enrollment.
Asthma Control TestAt study enrollmentACT score using the ACT questionnaire
Clinical utilizationOne year (study period)Caregivers were asked if child had a scheduled or unscheduled (urgent) clinical visit with a doctor or health care provider, emergency department, or overnight hospitalization for asthma symptoms. Number and types of visits are reported.
Inflammatory markers of asthma: Urinary leukotriene1 year (study period)Measured urinary leukotriene concentration and specific gravity in child urine sample. Measurements collected at enrollment, mid-study (4-6 months after enrollment), and end of study (1 year after enrollment)
Inflammatory markers of asthma: Fractional exhaled nitric oxideAt study enrollmentPortable NIOX VERO (Aerocrine Inc, Stockholm, Sweden) for direct measurement of fractional exhaled nitric oxide.
Asthma exacerbationOne year (study period)Reviewed participant medical records for receipt of prescription for a course of oral corticosteroid.
Lung functionAt study enrollmentMeasured lung fuction using EasyOne spirometer (NDD Technologies, Andover, MA). Minimum of three exhalations with acceptable starts, complete exhalation, and no coughs until two exhalations with acceptable repeatability was achieved.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026