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

Primary Purpose

Respiratory Tract Infections, Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Guatemala
Study Type
Interventional
Intervention
Plancha
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Tract Infections

Eligibility Criteria

undefined - 18 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Open fire

Chimney stove

Arm Description

Households continuing to use an open fire for cooking and heating

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

Outcomes

Primary Outcome Measures

The primary outcome measure was physician-diagnosed pneumonia in children

Secondary Outcome Measures

Severe (hypoxaemic) and RSV pneumonia

Full Information

First Posted
January 12, 2010
Last Updated
January 12, 2010
Sponsor
University of California, Berkeley
Collaborators
World Health Organization, Universidad del Valle, Guatemala, University of Liverpool
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1. Study Identification

Unique Protocol Identification Number
NCT01047696
Brief Title
Randomised Exposure Study of Pollution Indoors and Respiratory Effects
Acronym
RESPIRE
Official Title
Particulate Air Pollution Exposure and Childhood Acute Respiratory Infections in Guatemala: A Randomized Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Berkeley
Collaborators
World Health Organization, Universidad del Valle, Guatemala, University of Liverpool

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections, Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
537 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open fire
Arm Type
No Intervention
Arm Description
Households continuing to use an open fire for cooking and heating
Arm Title
Chimney stove
Arm Type
Experimental
Arm Description
Households randomized to receive a chimney stove (plancha) for cooking and heating
Intervention Type
Device
Intervention Name(s)
Plancha
Intervention Description
locally developed chimney stove
Primary Outcome Measure Information:
Title
The primary outcome measure was physician-diagnosed pneumonia in children
Time Frame
Through 18 months of age
Secondary Outcome Measure Information:
Title
Severe (hypoxaemic) and RSV pneumonia
Time Frame
Through 18 months of age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirk R Smith, PhD, MPH
Organizational Affiliation
UC Berkeley
Official's Role
Principal Investigator
Facility Information:
City
San Lorenzo
Country
Guatemala

12. IPD Sharing Statement

Citations:
PubMed Identifier
19443665
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.
Results Reference
background
PubMed Identifier
18533994
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.
Results Reference
background
PubMed Identifier
18034961
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.
Results Reference
background
PubMed Identifier
17637912
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.
Results Reference
background
PubMed Identifier
17183019
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.
Results Reference
background
PubMed Identifier
19536077
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.
Results Reference
result
PubMed Identifier
19057384
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.
Results Reference
result
PubMed Identifier
17768502
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.
Results Reference
result

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Randomised Exposure Study of Pollution Indoors and Respiratory Effects

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