title: 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.
abstract: BACKGROUND
  Acute lower respiratory infections (ALRI) are a leading cause of death among children. Low birthweight is prevalent in South Asia and associated with increased risks of mortality, and morbidity, high levels of indoor household air pollution caused by open burning of biomass fuels are common and associated with high rates of ALRI and low birthweight. Alternative stove designs that burn biomass fuel more efficiently have been proposed as one method for reducing these high exposures and lowering rates of these disorders. We designed two randomized trials to test this hypothesis.
  
  
  METHODS
  We conducted a pair of community-based, randomized trials of alternative cookstove installation in a rural district in southern Nepal. Phase one was a cluster randomized, modified step-wedge design using an alternative biomass stove with a chimney. A pre-installation period of morbidity assessment and household environmental assessment was conducted for six months in all households. This was followed by a one year step-wedge phase with 12 monthly steps for clusters of households to receive the alternative stove. The timing of alternative stove introduction was randomized. This step-wedge phase was followed in all households by another six month follow-up phase. Eligibility criteria for phase one included household informed consent, the presence of a married woman of reproductive age (15-30 yrs) or a child < 36 months. Children were followed until 36 months of age or the end of the trial. Pregnancies were identified and followed until completion or end of the trial. Phase two was an individually randomized trial of the same alternative biomass stove versus liquid propane gas stove in a subset of households that participated in phase one. Follow-up for phase two was 12 months following stove installation. Eligibility criteria included the same components as phase one except children were only enrolled for morbidity follow-up if they were less than 24 months.The primary outcomes included: incidence of ALRI in children and birthweight.
  
  
  CONCLUSIONS
  We presented the design and methods of two randomized trials of alternative cookstoves on rates of ALRI and birthweight.
  
  
  BACKGROUND
  Clinicaltrials.gov (NCT00786877, Nov. 5, 2008).
authors.affiliation: Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA. jtielsch@gwu.edu.
authors.forename: James M
authors.initials: JM
authors.lastname: Tielsch
authors.forename: Joanne
authors.initials: J
authors.lastname: Katz
authors.forename: Scott L
authors.initials: SL
authors.lastname: Zeger
authors.forename: Subarna K
authors.initials: SK
authors.lastname: Khatry
authors.forename: Laxman
authors.initials: L
authors.lastname: Shrestha
authors.forename: Patrick
authors.initials: P
authors.lastname: Breysse
authors.forename: William
authors.initials: W
authors.lastname: Checkley
authors.forename: Luke C
authors.initials: LC
authors.lastname: Mullany
authors.forename: Steven C
authors.initials: SC
authors.lastname: LeClerq
mesh_terms: D000293:Adolescent; D000328:Adult; D016902:Air Pollution, Indoor / Q000032:analysis; D001724:Birth Weight; D002675:Child, Preschool; D003296:Cooking / Q000379:methods*; D005191:Family Characteristics; D005260:Female; D005865:Gestational Age; D006801:Humans; D007223:Infant; D008297:Male; D009390:Nepal / Q000453:epidemiology; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology*; D012107:Research Design; D012129:Respiratory Function Tests; D012141:Respiratory Tract Infections / Q000453:epidemiology*; D012306:Risk; D012424:Rural Population