- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01047696
Randomised Exposure Study of Pollution Indoors and Respiratory Effects (RESPIRE)
January 12, 2010 updated by: University of California, Berkeley
Particulate Air Pollution Exposure and Childhood Acute Respiratory Infections in Guatemala: A Randomized Intervention
The purpose of this study was to determine whether reduced exposure to indoor air pollution would reduce ALRI incidence in children <18 months of age.
Households were randomized to receive a chimney stove (intervention group) or continue using an open fire for cooking and heating (control group).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Acute lower respiratory infections (ALRI) are the chief killer of children.
Most cases are pneumonia and the majority occur among poor children under five years in developing countries.
Poverty might be said to be the primary cause, which manifests as malnutrition, including micro-nutrient deficiencies, and lack of access to medical care.
Another attribute of poverty is household indoor air pollution (HAP) from use of unprocessed solid fuels such as biomass (wood, animal dung and crop wastes) and coal in simple stoves.
A meta-analysis of published observational studies found that young children exposed to smoke from household solid fuel use had a rate of ALRI twice that of children not exposed or where clean fuels were used.
Recent studies have shown similar ALRI risks associated with short-term air pollution measurements and other indicators of exposure.
Study Type
Interventional
Enrollment (Actual)
537
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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San Lorenzo, Guatemala
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Households were invited to participate in the study if they met the following inclusion criteria:
- Used only an open fire for cooking and heating
- Had a pregnant woman or child < 4 months residing in the home
- Identified as Mam (the regional ethnic group), and had
- Minimal summer migration (less than 12 weeks per year)
Exclusion Criteria:
Households were excluded from participating if:
- The household was already using a chimney stove for cooking
- There was no child <4 months of age or a pregnant woman residing in the home
- Seasonal migration required the family to move to another region for more than 12 weeks of the year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Open fire
Households continuing to use an open fire for cooking and heating
|
|
Experimental: Chimney stove
Households randomized to receive a chimney stove (plancha) for cooking and heating
|
locally developed chimney stove
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome measure was physician-diagnosed pneumonia in children
Time Frame: Through 18 months of age
|
Through 18 months of age
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Severe (hypoxaemic) and RSV pneumonia
Time Frame: Through 18 months of age
|
Through 18 months of age
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kirk R Smith, PhD, MPH, UC Berkeley
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Smith-Sivertsen T, Diaz E, Pope D, Lie RT, Diaz A, McCracken J, Bakke P, Arana B, Smith KR, Bruce N. Effect of reducing indoor air pollution on women's respiratory symptoms and lung function: the RESPIRE Randomized Trial, Guatemala. Am J Epidemiol. 2009 Jul 15;170(2):211-20. doi: 10.1093/aje/kwp100. Epub 2009 May 14.
- Diaz E, Bruce N, Pope D, Diaz A, Smith KR, Smith-Sivertsen T. Self-rated health among Mayan women participating in a randomised intervention trial reducing indoor air pollution in Guatemala. BMC Int Health Hum Rights. 2008 Jun 5;8:7. doi: 10.1186/1472-698X-8-7.
- Diaz E, Bruce N, Pope D, Lie RT, Diaz A, Arana B, Smith KR, Smith-Sivertsen T. Lung function and symptoms among indigenous Mayan women exposed to high levels of indoor air pollution. Int J Tuberc Lung Dis. 2007 Dec;11(12):1372-9.
- McCracken JP, Smith KR, Diaz A, Mittleman MA, Schwartz J. Chimney stove intervention to reduce long-term wood smoke exposure lowers blood pressure among Guatemalan women. Environ Health Perspect. 2007 Jul;115(7):996-1001. doi: 10.1289/ehp.9888.
- Diaz E, Smith-Sivertsen T, Pope D, Lie RT, Diaz A, McCracken J, Arana B, Smith KR, Bruce N. Eye discomfort, headache and back pain among Mayan Guatemalan women taking part in a randomised stove intervention trial. J Epidemiol Community Health. 2007 Jan;61(1):74-9. doi: 10.1136/jech.2006.043133.
- Smith KR, McCracken JP, Thompson L, Edwards R, Shields KN, Canuz E, Bruce N. Personal child and mother carbon monoxide exposures and kitchen levels: methods and results from a randomized trial of woodfired chimney cookstoves in Guatemala (RESPIRE). J Expo Sci Environ Epidemiol. 2010 Jul;20(5):406-16. doi: 10.1038/jes.2009.30. Epub 2009 Jun 17.
- McCracken JP, Schwartz J, Bruce N, Mittleman M, Ryan LM, Smith KR. Combining individual- and group-level exposure information: child carbon monoxide in the Guatemala woodstove randomized control trial. Epidemiology. 2009 Jan;20(1):127-36. doi: 10.1097/EDE.0b013e31818ef327.
- Bruce N, Weber M, Arana B, Diaz A, Jenny A, Thompson L, McCracken J, Dherani M, Juarez D, Ordonez S, Klein R, Smith KR. Pneumonia case-finding in the RESPIRE Guatemala indoor air pollution trial: standardizing methods for resource-poor settings. Bull World Health Organ. 2007 Jul;85(7):535-44. doi: 10.2471/blt.06.035832.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Primary Completion (Actual)
December 1, 2004
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
January 12, 2010
First Submitted That Met QC Criteria
January 12, 2010
First Posted (Estimate)
January 13, 2010
Study Record Updates
Last Update Posted (Estimate)
January 13, 2010
Last Update Submitted That Met QC Criteria
January 12, 2010
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003-8-165
- R01ES010178 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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