Skip to main content
OpenTrials
Completed

NCT Number: NCT00786877

Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nepal Nutrition Intervention Project Sarlahi

Kathmandu, Nepal

About this study

See brief summary above

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Improved biomass cookstove with exterior ventilation

Other

Improved cookstove design installed in house that is higher efficiency and is vented to the exterior.

Other names: Envirofit model G3555.

Phase 2 intervention arm (LPG stove)

Other

LPG two burner stove with a 12 month supply of LP gas.

Primary outcomes

  1. Incidence of acute lower respiratory illness.

    Time frame: <36 months of age

  2. Incidence of Low Birthweight

    Time frame: All live births

Secondary outcomes

  1. Incidence of pre-term birth

    Time frame: all live births

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

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

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Nov 6, 2008
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.