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

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
Universidad del Valle, Guatemala
University of Liverpool
Information provided by:
University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT01047696
First received: January 12, 2010
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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).


Condition Intervention
Respiratory Tract Infections
Pneumonia
Device: Plancha

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Particulate Air Pollution Exposure and Childhood Acute Respiratory Infections in Guatemala: A Randomized Intervention

Resource links provided by NLM:


Further study details as provided by University of California, Berkeley:

Primary Outcome Measures:
  • The primary outcome measure was physician-diagnosed pneumonia in children [ Time Frame: Through 18 months of age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Severe (hypoxaemic) and RSV pneumonia [ Time Frame: Through 18 months of age ] [ Designated as safety issue: Yes ]

Enrollment: 537
Study Start Date: October 2002
Study Completion Date: March 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Open fire
Households continuing to use an open fire for cooking and heating
Experimental: Chimney stove
Households randomized to receive a chimney stove (plancha) for cooking and heating
Device: Plancha
locally developed chimney stove

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

Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047696

Locations
Guatemala
San Lorenzo, Guatemala
Sponsors and Collaborators
University of California, Berkeley
World Health Organization
Universidad del Valle, Guatemala
University of Liverpool
Investigators
Principal Investigator: Kirk R Smith, PhD, MPH UC Berkeley
  More Information

Publications:

Responsible Party: Prof. Kirk R. Smith, UC Berkeley
ClinicalTrials.gov Identifier: NCT01047696     History of Changes
Other Study ID Numbers: 2003-8-165, R01ES010178
Study First Received: January 12, 2010
Last Updated: January 12, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Communicable Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014