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Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal

Primary Purpose

Acute Lower Respiratory Illness

Status
Completed
Phase
Phase 3
Locations
Nepal
Study Type
Interventional
Intervention
Improved biomass cookstove with exterior ventilation
Phase 2 intervention arm (LPG stove)
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Lower Respiratory Illness focused on measuring pneumonia

Eligibility Criteria

undefined - 36 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Nepal Nutrition Intervention Project Sarlahi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Improved biomass cookstove with exterior ventilation

Traditional cookstove

Phase 2 invervention arm (LPG stove)

Arm Description

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.

In phase 1, the control arm is the traditional standard open burning cookstove in house.

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.

Outcomes

Primary Outcome Measures

Incidence of acute lower respiratory illness.
Incidence of Low Birthweight

Secondary Outcome Measures

Incidence of pre-term birth

Full Information

First Posted
November 5, 2008
Last Updated
January 15, 2015
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Environmental Health Sciences (NIEHS), Nepal Nutrition Intervention Project Sarlahi, Thrasher Research Fund, Tribhuvan University, Nepal
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1. Study Identification

Unique Protocol Identification Number
NCT00786877
Brief Title
Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal
Official Title
Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Environmental Health Sciences (NIEHS), Nepal Nutrition Intervention Project Sarlahi, Thrasher Research Fund, Tribhuvan University, Nepal

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
See brief summary above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lower Respiratory Illness
Keywords
pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4678 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Improved biomass cookstove with exterior ventilation
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional cookstove
Arm Type
No Intervention
Arm Description
In phase 1, the control arm is the traditional standard open burning cookstove in house.
Arm Title
Phase 2 invervention arm (LPG stove)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Improved biomass cookstove with exterior ventilation
Other Intervention Name(s)
Envirofit model G3555.
Intervention Description
Improved cookstove design installed in house that is higher efficiency and is vented to the exterior.
Intervention Type
Other
Intervention Name(s)
Phase 2 intervention arm (LPG stove)
Intervention Description
LPG two burner stove with a 12 month supply of LP gas.
Primary Outcome Measure Information:
Title
Incidence of acute lower respiratory illness.
Time Frame
<36 months of age
Title
Incidence of Low Birthweight
Time Frame
All live births
Secondary Outcome Measure Information:
Title
Incidence of pre-term birth
Time Frame
all live births

10. Eligibility

Sex
All
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James M Tielsch, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nepal Nutrition Intervention Project Sarlahi
City
Kathmandu
Country
Nepal

12. IPD Sharing Statement

Citations:
PubMed Identifier
25511324
Citation
Tielsch JM, Katz J, Zeger SL, Khatry SK, Shrestha L, Breysse P, Checkley W, Mullany LC, LeClerq SC. Designs of two randomized, community-based trials to assess the impact of alternative cookstove installation on respiratory illness among young children and reproductive outcomes in rural Nepal. BMC Public Health. 2014 Dec 15;14:1271. doi: 10.1186/1471-2458-14-1271.
Results Reference
derived

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Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal

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