Randomised Exposure Study of Pollution Indoors and Respiratory Effects

Pneumonia Clinical Trial

— RESPIRE  

Official title:

Particulate Air Pollution Exposure and Childhood Acute Respiratory Infections in Guatemala: A Randomized Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047696
• Other study ID #: 2003-8-165
• Secondary ID: R01ES010178
• Status: Completed
• Phase: N/A
• First received: January 12, 2010
• Last updated: January 12, 2010
• Start date: October 2002
• Est. completion date: March 2005

Study information

• Verified date: August 2009
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: March 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 18 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Respiratory Tract Infections

Intervention

Device:
• Plancha
locally developed chimney stove

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Berkeley	Universidad del Valle, Guatemala, University of Liverpool, World Health Organization

Country where clinical trial is conducted

Guatemala, 

References & Publications (8)

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 Worl — View Citation

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. doi: 10.1186/1472-698X-8-7. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

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. doi: 10.1093/aje/kwp100. Epub 2009 May 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure was physician-diagnosed pneumonia in children		Through 18 months of age	Yes
Secondary	Severe (hypoxaemic) and RSV pneumonia		Through 18 months of age	Yes