Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal

January 15, 2015 updated by: James M. Tielsch, Johns Hopkins Bloomberg School of Public Health
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. The project has 2 phases. Phase 1 is a cluster-randomized, community-based, step-wedge 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. Phase 2 is a individually randomized trial in a subset of households that will receive either the improved biomass stove from phase 1 or a LPG stove and gas. Follow-up for phase 2 will be for 12 months with the same outcomes as phase 1. Measurement of indoor air particulate concentration will be conducted in all households before and after stove replacement. The analysis for both phases 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. Approximately 4200 children 1-35 months of age will be required to observe a minimum 10% reduction in risk of ARI with 90% power in phase 1. 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%. Phase 2 will have lower power (total of 1800 households).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See brief summary above

Study Type

Interventional

Enrollment (Actual)

4678

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Kathmandu, Nepal
        • Nepal Nutrition Intervention Project Sarlahi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Phase 1

Inclusion Criteria:

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

Exclusion Criteria:

  • Houses with walls of thatch or bamboo

Phase 2

Inclusion criteria:

  • households in the phase 1 study area that either participated in phase 1 or are newly eligible household since phase 1 began. Eligible households are those with either a resident married pregnant woman or at least one child less than 24 months of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Improved biomass cookstove with exterior ventilation

In phase 1, installation of an improved cookstove with ventilation to exterior is the active arm.

In phase 2, this improved biomass cookstove is the control arm.
Other: Improved biomass cookstove with exterior ventilation
Improved cookstove design installed in house that is higher efficiency and is vented to the exterior.
Other Names:
  • Envirofit model G3555.
No Intervention: Traditional cookstove
In phase 1, the control arm is the traditional standard open burning cookstove in house.
Experimental: Phase 2 invervention arm (LPG stove)
In phase 2 of this project, households are individually randomized to either continuation of the improved biomass stove from phase 1, or a new LPG stove and gas for 12 months.
Other: Phase 2 intervention arm (LPG stove)
LPG two burner stove with a 12 month supply of LP gas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of acute lower respiratory illness.
Time Frame: <36 months of age
<36 months of age
Incidence of Low Birthweight
Time Frame: All live births
All live births

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of pre-term birth
Time Frame: all live births
all live births

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

National Institute of Environmental Health Sciences (NIEHS)
Thrasher Research Fund
Tribhuvan University, Nepal
Nepal Nutrition Intervention Project Sarlahi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00000332
  • R01ES015558 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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