Randomised Exposure Study of Pollution Indoors and Respiratory Effects

NCT01047696 | Completed DMC

• 2 other identifiers: 2003-8-165R01ES010178
• Study Type: interventional
• Target: 537
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Tract Infections; Pneumonia

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure was physician-diagnosed pneumonia in children

  Through 18 months of age

Secondary Outcomes (1)

• Severe (hypoxaemic) and RSV pneumonia

  Through 18 months of age

Study Arms (2)

Open fire

NO INTERVENTION

Households continuing to use an open fire for cooking and heating

Chimney stove

EXPERIMENTAL

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

Device: Plancha

Interventions

Plancha DEVICE

locally developed chimney stove

Chimney stove

Eligibility Criteria

• Age: Up to 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead
• World Health Organization: collaborator
• Universidad del Valle, Guatemala: collaborator
• University of Liverpool: collaborator

Study Sites (1)

Unknown Facility

San Lorenzo, Guatemala

Location

Related Publications (8)

• 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.

  PMID: 19443665 BACKGROUND

• 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.

  PMID: 18533994 BACKGROUND

• 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.

  PMID: 18034961 BACKGROUND

• 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.

  PMID: 17637912 BACKGROUND

• 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.

  PMID: 17183019 BACKGROUND

• 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.

  PMID: 19536077 RESULT

• 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.

  PMID: 19057384 RESULT

• 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.

  PMID: 17768502 RESULT

MeSH Terms

Conditions

Respiratory Tract Infections; Pneumonia

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Kirk R Smith, PhD, MPH

  UC Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: October 1, 2002
• Primary Completion: December 1, 2004
• Study Completion: March 1, 2005
• Last Updated: January 13, 2010

Record last verified: 2009-08

Locations

GU (1)