Randomised Exposure Study of Pollution Indoors and Respiratory Effects - Full Text View

Purpose

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).

Condition	Intervention
Respiratory Tract Infections Pneumonia	Device: Plancha

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Particulate Air Pollution Exposure and Childhood Acute Respiratory Infections in Guatemala: A Randomized Intervention

Resource links provided by NLM:

MedlinePlus related topics: Air Pollution Fires Pneumonia

U.S. FDA Resources

Further study details as provided by University of California, Berkeley:

Primary Outcome Measures:

The primary outcome measure was physician-diagnosed pneumonia in children [ Time Frame: Through 18 months of age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Severe (hypoxaemic) and RSV pneumonia [ Time Frame: Through 18 months of age ] [ Designated as safety issue: Yes ]

Enrollment:	537
Study Start Date:	October 2002
Study Completion Date:	March 2005
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Device: Plancha locally developed chimney stove

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.

Eligibility

Ages Eligible for Study:	up to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047696

Locations

Guatemala

San Lorenzo, Guatemala

Sponsors and Collaborators

University of California, Berkeley

World Health Organization

Universidad del Valle, Guatemala

University of Liverpool

Investigators

Principal Investigator:

Kirk R Smith, PhD, MPH

UC Berkeley

More Information

Publications:

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. 2009 Jun 17; [Epub ahead of print]

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.

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.

Smith-Sivertsen T, Díaz E, Pope D, Lie RT, Díaz 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. Epub 2009 May 14.

Díaz E, Bruce N, Pope D, Díaz 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.

Díaz E, Bruce N, Pope D, Lie RT, Díaz 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, Díaz 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.

Díaz E, Smith-Sivertsen T, Pope D, Lie RT, Díaz 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.

Responsible Party:	Prof. Kirk R. Smith, UC Berkeley
ClinicalTrials.gov Identifier:	NCT01047696 History of Changes
Other Study ID Numbers:	2003-8-165, R01ES010178
Study First Received:	January 12, 2010
Last Updated:	January 12, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Infection

ClinicalTrials.gov processed this record on May 19, 2013

Randomised Exposure Study of Pollution Indoors and Respiratory Effects (RESPIRE)