San Lorenzo, Guatemala
NCT Number: NCT01047696
Randomised Exposure Study of Pollution Indoors and Respiratory Effects
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).
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Notify MeKey information
Conditions
Age range
Up to 18 month
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Plancha
Devicelocally developed chimney stove
Primary outcomes
-
The primary outcome measure was physician-diagnosed pneumonia in children
Time frame: Through 18 months of age
Secondary outcomes
-
Severe (hypoxaemic) and RSV pneumonia
Time frame: Through 18 months of age
Sponsors and collaborators
Lead sponsor
University of California, Berkeley
Other
Collaborators
- Universidad del Valle, Guatemala
- University of Liverpool
- World Health Organization
Registry information
Official study title
Particulate Air Pollution Exposure and Childhood Acute Respiratory Infections in Guatemala: A Randomized Intervention
Acronym: RESPIRE
Important dates
- Study start
- 2002
- Primary completion
- 2004
- Study completion
- 2005
- First posted
- Jan 13, 2010
- Registry last updated
- Jan 13, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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