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Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal
This study is not yet open for participant recruitment.
Verified by Johns Hopkins Bloomberg School of Public Health, November 2008
Sponsors and Collaborators: Johns Hopkins Bloomberg School of Public Health
National Institute of Environmental Health Sciences, NIH
Centre for Rural Technology, Nepal
Nepal Nutrition Intervention Project, Sarlahi
Information provided by: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00786877
  Purpose

The goals of our research program are to determine which interventions are most effective at reducing the burden of mortality and morbidity among women and children in high-risk populations in developing countries. At our field site in southern Nepal, acute respiratory illness (ARI) has been a leading cause of mortality among young children. Besides immunization there is little evidence for effective primary preventive approaches for ARI on a population basis. Low birth weight is highly prevalent in this population as well affecting approximately 30% of live born infants. Low birth weight is a key determinant of neonatal mortality and has also been resistant to cost-effective interventions in resource poor settings. Given the lack of appropriate interventions for poor, rural areas in developing countries and the strong observational association between open burning of biomass fuel sources and ARI in young children and low birth weight, we have designed a community-based randomized trial to determine if reductions in household indoor smoke exposure can reduce the incidence and duration of acute lower respiratory infections in children <36 months of age and low birthweight among newborn infants. Household indoor smoke reduction will be accomplished by replacing the current cook stove in the household with a locally appropriate, inexpensive model that is more efficient and vented to the exterior. In addition, we will assess the impact on respiratory function and symptoms among adults in the household, including women of reproductive age, and compare total fuel consumption and time spent collecting fuel for the household. The project is a cluster-randomized, community-based trial of cookstove replacement in a rural population of southern Nepal. Households will be randomized to receive replacement of their cook stove with an appropriately designed, efficient stove that is vented to the exterior at different time periods during the course of the study. An initial period of surveillance for ARI and low birth weight will establish a baseline rate for all clusters. This will be followed by the randomized, serial replacements of cook stoves over a 12 month period. Surveillance will continue throughout this period and for an additional 6 -18 months depending on when the stove was replaced. Two cohorts of sectors will enter the trial sequentially. Measurement of indoor air particulate concentration will be conducted in a sample of households before and after stove replacement. The analysis will focus on estimating the impact on incidence of ARI in children and low birth weight among live births as a result of stove replacement. We will also assess the relative efficiency of the new stoves by identifying fuel consumption in the household and time spent collecting fuel. Approximately 4200 children 1-35 months of age will be required to observe a minimum 10% reduction in risk of ARI with 90% power. Given the expected number of live births to occur in these clusters, we can detect a 50 gram difference in birthweight with over 90% power and a type I error of 5%.


Condition Intervention Phase
Acute Lower Respiratory Illness
Other: Improved cookstove with exterior ventilation
Phase III

MedlinePlus related topics: Smoking and Youth
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Crossover Assignment, Efficacy Study
Official Title: Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Incidence of acute lower respiratory illness. [ Time Frame: 1-36 months of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of low birthweight [ Time Frame: all live births ] [ Designated as safety issue: No ]

Estimated Enrollment: 4200
Study Start Date: March 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Improved cookstove: Experimental
Installation of improved cookstove with ventilation to exterior.
Other: Improved cookstove with exterior ventilation
Improved cookstove design installed in house that is higher efficiency and is vented to the exterior.
Traditional cookstove: No Intervention
Standard open burning cookstove in house.

  Eligibility

Ages Eligible for Study:   1 Month to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All households with traditional open burning cookstoves in the study area.

Exclusion Criteria:

  • Houses with walls of thatch or bamboo
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786877

Contacts
Contact: James M Tielsch, PhD 410-955-2436 jtielsch@jhsph.edu

Locations
Nepal
Nepal Nutrition Intervention Project Sarlahi
Kathmandu, Nepal
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute of Environmental Health Sciences, NIH
Centre for Rural Technology, Nepal
Nepal Nutrition Intervention Project, Sarlahi
Investigators
Principal Investigator: James M Tielsch, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

Responsible Party: Johns Hopkins Bloomberg School of Public Health ( James M. Tielsch )
Study ID Numbers: IRB00000332, R01 ES015558
Study First Received: November 5, 2008
Last Updated: November 5, 2008
ClinicalTrials.gov Identifier: NCT00786877  
Health Authority: United States: Institutional Review Board;   Nepal: Nepal Health Research Council IRB

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
pneumonia

Study placed in the following topic categories:
Body Weight
Birth Weight
Signs and Symptoms
Pneumonia

ClinicalTrials.gov processed this record on January 16, 2009