Randomised Exposure Study of Pollution Indoors and Respiratory Effects

NCT ID: NCT01047696

Last Updated: 2010-01-13

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

537 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Tract Infections Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open fire

Households continuing to use an open fire for cooking and heating

Group Type NO_INTERVENTION

No interventions assigned to this group

Chimney stove

Households randomized to receive a chimney stove (plancha) for cooking and heating

Group Type EXPERIMENTAL

Plancha

Intervention Type DEVICE

locally developed chimney stove

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Plancha

locally developed chimney stove

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

World Health Organization

OTHER

Sponsor Role collaborator

Universidad del Valle, Guatemala

OTHER

Sponsor Role collaborator

University of Liverpool

OTHER

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

UC Berkeley

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kirk R Smith, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

UC Berkeley

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

San Lorenzo, , Guatemala

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Guatemala

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19443665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18533994 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18034961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17637912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17183019 (View on PubMed)

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.

Reference Type RESULT
PMID: 19536077 (View on PubMed)

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.

Reference Type RESULT
PMID: 19057384 (View on PubMed)

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.

Reference Type RESULT
PMID: 17768502 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01ES010178

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2003-8-165

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.