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Impact of Improved "Injera" Baking Stove Use on Childhood Acute Respiratory Infection Prevention in Northwest Ethiopia

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ClinicalTrials.gov Identifier: NCT03612362
Recruitment Status : Unknown
Verified August 2018 by Mesafint Molla, Bahir Dar University.
Recruitment status was:  Recruiting
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Mesafint Molla, Bahir Dar University

Brief Summary:

In Ethiopia, great majorities (95%) of households rely on solid biomass fuels such as wood, muck, crop residues, and charcoal burned in highly polluting stoves to meet the basic household energy needs with its severe health consequences due to emission of toxic indoor air pollutants. Correspondingly, household air pollution (HAP) from biomass fuel use is now estimated to be responsible for nearly 3.5 million premature deaths annually, with the highest disease burdens experienced by countries in sub-Saharan Africa. HAP ranks as the highest environmental risk factors to premature deaths globally and 2nd leading risk factor next to childhood underweight in most of sub-Saharan Africa countries as well as 3rd leading risk factor of disease next to childhood underweight, and suboptimal breastfeeding in Ethiopia.

Usually prevention efforts aimed at reducing HAP and related health burdens have been focused on the use of energy efficient cookstoves. There is, however, rigorous lack of evidence in Ethiopia or in other similar settings whether it is possible to achieve adequate HAP reduction and improve health with locally made energy efficient baking stoves from a public health point of view. Particularly, the popular Ethiopian energy efficient "Injera" baking stove has not been researched through stove trial inquiry. Therefore, research studies are required in Ethiopia on health benefits achieved when households adopt energy efficient baking stoves. In view of that, cluster randomized controlled trial will be employed with experimental study design for one year to test the effectiveness of the Ethiopian improved "Injera" baking stove intervention on reducing HAP and childhood acute respiratory infection (ARI) through comparing equal size groups of children before and after part of households received an improved "Injera" baking stove.

Accordingly, the proposed stove trial aims to address an important research gap by determining whether the Ethiopian improved "Injera" baking biomass stove intervention can adequately reduce HAP exposure to prevent childhood acute respiratory infection. With this objective, the proposed stove trial will test the hypothesis that there is a statistically significant difference in HAP levels and incidence of childhood ARI when using traditional versus improved "Injera" baking stove in Northwest Ethiopia


Condition or disease Intervention/treatment Phase
Acute Respiratory Infection Pneumonia Childhood Device: Improved "Injera" Baking Biomass Stove Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized control trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Improved "Injera" Baking Stove Intervention on Household Air Pollution and Childhood Acute Respiratory Infection Prevention: A Cluster Randomized Controlled Trial In Northwest Ethiopia
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Improved "Injera" Baking Biomass Stove
2750 eligible households with in 50 randomly selected clusters/"Gotes" are allocated into the improved "Injera" backing stove intervention arm.
Device: Improved "Injera" Baking Biomass Stove
Replacing of the Ethiopian traditional "Injera" baking biomass stove with improved baking biomass stove, the well-known commercially distributed type of baking stove in Ethiopia, will be the intervention for this study. Control HHs will continue to use the traditional baking biomass stove. Concerning intervention duration, since the life span of the Ethiopian improved baking stove is about 5 years, the length of the intervention period will be one year to account for seasonal factors that have major effect on both ARI incidence & HAP level in Ethiopia as well as to maintain a balance between achieving a sufficiently long follow-up period for outcome measurements & suitably short follow-up period to decrease attrition.

No Intervention: Control arm
Similarly 2750 eligible households with in 50 randomly selected clusters/Gotes will continue to use the traditional "Injera" baking biomass stove and will be used as control arm.



Primary Outcome Measures :
  1. Longitudinal proportion of childhood acute respiratory infection as measured by childhood pneumonia status using World Health Organization's Integrated Management of Neonatal and Childhood Illness algorism. [ Time Frame: Change from baseline childhood ARI due to Improved "Injera" Baking Stove Intervention will be assessed at one year. ]
    Childhood acute respiratory infection/pneumonia status will be assessed using standard case recording form by field workers during household visits where the index child mothers/caregivers are asked about ARI signs & symptoms in the preceding two weeks. Moreover, to overcome some of the limitations of the self-reported health data, physical examination of the ill index child will be conducted by field workers trained in World Health Organization's Integrated Management of Neonatal and Childhood Illness algorism.


Secondary Outcome Measures :
  1. Household air pollution as measured by concentration of indoor particulate matter with an aerodynamic diameter of less than 2.5 microns (PM2.5) in µg/m3 [ Time Frame: Change from baseline HAP (indoor PM2.5 concentration) due to Improved "Injera" Baking Stove Intervention will be assessed at one year. ]
    To estimate the household level exposure to pollutant for each household enrolled in this longitudinal study, the concentration of PM2.5 will be measured in the main cooking area following Standard Operating Procedures.



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Ages Eligible for Study:   up to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Households with children up to 4 years old to ensure a minimum of one year longitudinal data collection before the child's 5th birthday.
  • Households who bake "Injera" exclusively with a traditional baking stove

Exclusion Criteria:

  • Households who do not have any enclosed main cooking area (kitchen) structure
  • Children who will be born during the course of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612362


Contacts
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Contact: Mesafint M. Adane, MPH,BSc., +251918121064 mesafintm@bdu.edu.et
Contact: Prof. Getu D. Alene, PhD, +251918776010 adgetu123@yahoo.com

Locations
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Ethiopia
"Mecha" Health and Demographic Surveillance System (MHDSS) Site, Bahir Dar University Recruiting
Bahir Dar, Amhara Regional State, Ethiopia, P.O.Box 79
Contact: Mesafint M. Adane, MPH, BSc.,    +251918121064    mesafintm@bdu.edu.et   
Contact: Prof. Getu D. Alene, PhD,    +251918776010    adgetu123@yahoo.com   
Principal Investigator: Mesafint M. Adane, MPH, BSc.         
Sub-Investigator: Prof. Getu D. Alene, PhD         
Sub-Investigator: Dr. Seid T. Mereta, PhD         
Sub-Investigator: Dr. Kristina Wanyonyi, PhD         
Sponsors and Collaborators
Bahir Dar University
Investigators
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Principal Investigator: Mesafint M. Adane, MPH,BSc., School of Public Health, College of Medicine and Health Sciences, Bahir Dar University, Ethiopia
Study Chair: Prof. Getu D. Alene, PhD, Department of Epidemiology and Biostatics, School of Public Health, College of Medicine and Health Sciences, Bahir Dar University, Ethiopia
Study Director: Dr. Seid T. Mereta, PhD, Department of Environmental Health Science & Technology, School of Public Health, Jimma University
Publications:
Budds J, Biran, A. & Rouse, J. What's Cooking: a review of the health impacts of indoor air pollution and technical interventions for its reduction. 2001
Desalegn B, Suleiman H, Asfaw A. Household fuel use and acute respiratory infections among younger children: an exposure assessment in Shebedino Wereda, Southern Ethiopia. African Journal of Health Sciences. 2011;18(1-2):31-6
Edwards R, Hubbard A, Khalakdina A, Pennise D, Smith KR. Design considerations for field studies of changes in indoor air pollution due to improved stoves. Energy for Sustainable Development June 2007;11(2)
Energy Sector Mapping and Database Development. Ethiopian Ministry of Water and Energy, 2013a
Household cookstove, environment, health, and climate change: a new look at an old problem, The World Bank, The Environment Department (Climate Change). 2011
Kumie A, Samet J, Berhane K. Air Pollution, Occupational Health and Safety, and Climate Change: Findings, research needs and policy implications establishing a GEOHealth Hub for East Africa. Situational analysis and needs assessment for Ethiopia. August 2014
Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, Amann M, Anderson HR, Andrews KG, Aryee M, Atkinson C, Bacchus LJ, Bahalim AN, Balakrishnan K, Balmes J, Barker-Collo S, Baxter A, Bell ML, Blore JD, Blyth F, Bonner C, Borges G, Bourne R, Boussinesq M, Brauer M, Brooks P, Bruce NG, Brunekreef B, Bryan-Hancock C, Bucello C, Buchbinder R, Bull F, Burnett RT, Byers TE, Calabria B, Carapetis J, Carnahan E, Chafe Z, Charlson F, Chen H, Chen JS, Cheng AT, Child JC, Cohen A, Colson KE, Cowie BC, Darby S, Darling S, Davis A, Degenhardt L, Dentener F, Des Jarlais DC, Devries K, Dherani M, Ding EL, Dorsey ER, Driscoll T, Edmond K, Ali SE, Engell RE, Erwin PJ, Fahimi S, Falder G, Farzadfar F, Ferrari A, Finucane MM, Flaxman S, Fowkes FG, Freedman G, Freeman MK, Gakidou E, Ghosh S, Giovannucci E, Gmel G, Graham K, Grainger R, Grant B, Gunnell D, Gutierrez HR, Hall W, Hoek HW, Hogan A, Hosgood HD 3rd, Hoy D, Hu H, Hubbell BJ, Hutchings SJ, Ibeanusi SE, Jacklyn GL, Jasrasaria R, Jonas JB, Kan H, Kanis JA, Kassebaum N, Kawakami N, Khang YH, Khatibzadeh S, Khoo JP, Kok C, Laden F, Lalloo R, Lan Q, Lathlean T, Leasher JL, Leigh J, Li Y, Lin JK, Lipshultz SE, London S, Lozano R, Lu Y, Mak J, Malekzadeh R, Mallinger L, Marcenes W, March L, Marks R, Martin R, McGale P, McGrath J, Mehta S, Mensah GA, Merriman TR, Micha R, Michaud C, Mishra V, Mohd Hanafiah K, Mokdad AA, Morawska L, Mozaffarian D, Murphy T, Naghavi M, Neal B, Nelson PK, Nolla JM, Norman R, Olives C, Omer SB, Orchard J, Osborne R, Ostro B, Page A, Pandey KD, Parry CD, Passmore E, Patra J, Pearce N, Pelizzari PM, Petzold M, Phillips MR, Pope D, Pope CA 3rd, Powles J, Rao M, Razavi H, Rehfuess EA, Rehm JT, Ritz B, Rivara FP, Roberts T, Robinson C, Rodriguez-Portales JA, Romieu I, Room R, Rosenfeld LC, Roy A, Rushton L, Salomon JA, Sampson U, Sanchez-Riera L, Sanman E, Sapkota A, Seedat S, Shi P, Shield K, Shivakoti R, Singh GM, Sleet DA, Smith E, Smith KR, Stapelberg NJ, Steenland K, Stöckl H, Stovner LJ, Straif K, Straney L, Thurston GD, Tran JH, Van Dingenen R, van Donkelaar A, Veerman JL, Vijayakumar L, Weintraub R, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams W, Wilson N, Woolf AD, Yip P, Zielinski JM, Lopez AD, Murray CJ, Ezzati M, AlMazroa MA, Memish ZA. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2224-60. doi: 10.1016/S0140-6736(12)61766-8. Erratum in: Lancet. 2013 Apr 13;381(9874):1276. Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added].
Meinert CL. Clinical Trials: Design, Conduct and Analysis. New York: Oxford University Press. 1986
Rehfuess E, Bruce N, Smith K. Solid Fuel Use: Health Effect. In: Nriagu JO (ed.) Encyclopedia of Environmental Health, v 5, pp. 150161 Burlington: Elsevier, 2011. Environmental Health. 2011;5:150161.
Smith KR, Dutta K, Chengappa C, Gusain P, Masera O, Berrueta V, et al. Monitoring and evaluation of improved biomass cookstove programs for indoor air quality and stove performance: conclusions from the Household Energy and Health Project. Energy for Sustainable Development. 2007;11(2):5-18
Welfare Monitoring Survey. Addis Ababa, Ethiopia: Central Statistical Agency, 2011.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mesafint Molla, Assistant Professor at School of Public Health, College of Medicine and Health Sciences, Bahir Dar University
ClinicalTrials.gov Identifier: NCT03612362    
Other Study ID Numbers: 088/18-04
U1111-1215-1090 ( Registry Identifier: Universal Trial Number )
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mesafint Molla, Bahir Dar University:
Acute Respiratory Infection, Household Air Pollution
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases