Clinical trial NCT01047696: Randomised Exposure Study of Pollution Indoors and Respiratory Effects
Official title: Particulate Air Pollution Exposure and Childhood Acute Respiratory Infections in Guatemala: A Randomized Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infections
Pneumonia
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Universidad del Valle, Guatemala
name: University of Liverpool
First posted: 2010-01-13
Enrollment: 537
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

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 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

Primary outcomes:
measure: The primary outcome measure was physician-diagnosed pneumonia in children
timeFrame: Through 18 months of age
Secondary outcomes:
measure: Severe (hypoxaemic) and RSV pneumonia
timeFrame: Through 18 months of age
Other outcomes:
Locations:
city: San Lorenzo
country: Guatemala
Study officials:
affiliation: UC Berkeley
name: Kirk R Smith, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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 Sci Environ Epidemiol. 2010 Jul;20(5):406-16. doi: 10.1038/jes.2009.30. Epub 2009 Jun 17.
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.0b013e31818ef327.
citation: 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.