Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborators:
Nepal Nutrition Intervention Project Sarlahi
Thrasher Research Fund
Tribhuvan University, Nepal
Information provided by (Responsible Party):
James M. Tielsch, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00786877
First received: November 5, 2008
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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).


Condition Intervention Phase
Acute Lower Respiratory Illness
Other: Improved biomass cookstove with exterior ventilation
Other: Phase 2 intervention arm (LPG stove)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of acute lower respiratory illness. [ Time Frame: <36 months of age ] [ Designated as safety issue: No ]
  • Incidence of Low Birthweight [ Time Frame: All live births ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of pre-term birth [ Time Frame: all live births ] [ Designated as safety issue: No ]

Estimated Enrollment: 4200
Study Start Date: August 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

Detailed Description:

See brief summary above

  Eligibility

Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT00786877

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

Locations
Nepal
Nepal Nutrition Intervention Project Sarlahi Recruiting
Kathmandu, Nepal
Sub-Investigator: Subarna K Khatry, MBBS         
Sub-Investigator: Steven C LeClerq, MPH         
Sub-Investigator: Ramesh K Adhikari, MD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Nepal Nutrition Intervention Project Sarlahi
Thrasher Research Fund
Tribhuvan University, Nepal
Investigators
Principal Investigator: James M Tielsch, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: James M. Tielsch, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00786877     History of Changes
Other Study ID Numbers: IRB00000332, R01 ES015558
Study First Received: November 5, 2008
Last Updated: April 3, 2013
Health Authority: United States: IRB, Johns Hopkins Bloomberg School of Public Health
Nepal: IRB, Institute of Medicine, Tribhuvan University

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

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Penicillin G Benzathine
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014