Skip to main content
Top
Published in: Trials 1/2022

Open Access 01-12-2022 | Study protocol

Reducing household air pollution exposure to improve early child growth and development; a randomized control trial protocol for the “Poriborton-Extension: The CHANge trial”

Authors: Camille Raynes-Greenow, Sk Masum Billah, Sajia Islam, S. M. Rokonuzzaman, Fahmida Tofail, Elizabeth K. Kirkwood, Ashraful Alam, Ryan Chartier, Tarana E. Ferdous, Shams El Arifeen, Michael J. Dibley, Nusrat Homaira, Alison Hayes, Jonathan Thornburg, Patrick Kelly

Published in: Trials | Issue 1/2022

Login to get access

Abstract

Background

Globally, household air pollution (HAP) is a leading environmental cause of morbidity and mortality. Our trial aims to assess the impact of liquefied petroleum gas (LPG) for cooking to reduce household air pollution exposure on child health outcomes, compared to usual cooking practices in Bangladesh. The primary aim is to evaluate if reduced exposure to HAP through the provision of LPG for cooking from early gestation through to age 2 improves child anthropometry, health, and neuro-cognitive developmental outcomes, compared to children exposed to emissions from usual practice.

Methods

Two-arm parallel cluster randomized controlled trial (cCRT). We will extend the intervention and follow-up of our existing “Poriborton” trial. In a subset of the original surviving participants, we will supply LPG cylinders and LPG stoves (intervention) compared to usual cooking practices and extend the follow-up to 24 months of age. The expected final sample size, for both (intervention and control) is 1854 children with follow-up to 2 years of age available for analysis.

Discussion

This trial will answer important research gaps related to HAP and child health and neuro-cognitive developmental outcomes. This evidence will help to understand the impact of a HAP intervention on child health to inform policies for the adoption of clean fuel in Bangladesh and other similar settings.

Trial registration

The Poriborton: Change trial: Household Air Pollution and Perinatal and early Neonatal mortality is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001214224, original trial registered on 19th July 2018, extension approved on 23rd June 2021. www.​anzctr.​org.​au.
Literature
1.
go back to reference Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:200–7.CrossRef Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:200–7.CrossRef
2.
go back to reference SForouzanfar, Mohammad H et al. Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990–2015: a systematic analysis for the Global Burden of Disease Study. Lancet. 2015;388(10053):1659-724. SForouzanfar, Mohammad H et al. Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990–2015: a systematic analysis for the Global Burden of Disease Study. Lancet. 2015;388(10053):1659-724.
4.
go back to reference Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, et al. 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. 2013;380(9859):2224–60.CrossRef Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, et al. 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. 2013;380(9859):2224–60.CrossRef
5.
go back to reference Bruce N, Dherani M, Das JK, Balakrishnan K, Adair-Rohani H, Bhutta ZA, et al. Control of household air pollution for child survival: estimates for intervention impacts. BMC Public Health. 2013;13(Suppl 3):1–3.CrossRef Bruce N, Dherani M, Das JK, Balakrishnan K, Adair-Rohani H, Bhutta ZA, et al. Control of household air pollution for child survival: estimates for intervention impacts. BMC Public Health. 2013;13(Suppl 3):1–3.CrossRef
6.
go back to reference UNICEF, WHO and the World Bank Group. Levels and trends in child malnutrition: key findings of the 2021 edition of the joint child malnutrition estimates. In: Edited by Fund UNCs. New York: United Nations Children’s Fund (UNICEF), World Health Organization, International Bank for Reconstruction and Development/The World Bank; 2021. UNICEF, WHO and the World Bank Group. Levels and trends in child malnutrition: key findings of the 2021 edition of the joint child malnutrition estimates. In: Edited by Fund UNCs. New York: United Nations Children’s Fund (UNICEF), World Health Organization, International Bank for Reconstruction and Development/The World Bank; 2021.
7.
go back to reference Balmes JR. When the fetus is exposed to smoke, the developing lung is burned. Am J Respir Crit Care Med. 2019;199(6):684–5.CrossRef Balmes JR. When the fetus is exposed to smoke, the developing lung is burned. Am J Respir Crit Care Med. 2019;199(6):684–5.CrossRef
8.
go back to reference Islam S, Rana MJ, Mohanty SK. Cooking, smoking, and stunting: effects of household air pollution sources on childhood growth in India. Indoor Air. 2021;31(1):229–49.CrossRef Islam S, Rana MJ, Mohanty SK. Cooking, smoking, and stunting: effects of household air pollution sources on childhood growth in India. Indoor Air. 2021;31(1):229–49.CrossRef
9.
go back to reference Sinharoy SS, Clasen T, Martorell R. Air pollution and stunting: a missing link? Lancet Glob Health. 2020;8(4):e472–5.CrossRef Sinharoy SS, Clasen T, Martorell R. Air pollution and stunting: a missing link? Lancet Glob Health. 2020;8(4):e472–5.CrossRef
10.
go back to reference Perera FP, Li Z, Whyatt R, Hoepner L, Wang S, Camann D, et al. Prenatal airborne polycyclic aromatic hydrocarbon exposure and child IQ at age 5 years. Pediatrics. 2009;124(2):e195–202.CrossRef Perera FP, Li Z, Whyatt R, Hoepner L, Wang S, Camann D, et al. Prenatal airborne polycyclic aromatic hydrocarbon exposure and child IQ at age 5 years. Pediatrics. 2009;124(2):e195–202.CrossRef
11.
go back to reference Lin C-C, Yang S-K, Lin K-C, Ho W-C, Hsieh W-S, Shu B-C, et al. Multilevel analysis of air pollution and early childhood neurobehavioral development. Int J Environ Res Public Health. 2014;11(7):6827–41.CrossRef Lin C-C, Yang S-K, Lin K-C, Ho W-C, Hsieh W-S, Shu B-C, et al. Multilevel analysis of air pollution and early childhood neurobehavioral development. Int J Environ Res Public Health. 2014;11(7):6827–41.CrossRef
12.
go back to reference Edwards SC, Jedrychowski W, Butscher M, Camann D, Kieltyka A, Mroz E, et al. Prenatal exposure to airborne polycyclic aromatic hydrocarbons and children’s intelligence at 5 years of age in a prospective cohort study in Poland. Environ Health Perspect. 2010;118(9):1326–31.CrossRef Edwards SC, Jedrychowski W, Butscher M, Camann D, Kieltyka A, Mroz E, et al. Prenatal exposure to airborne polycyclic aromatic hydrocarbons and children’s intelligence at 5 years of age in a prospective cohort study in Poland. Environ Health Perspect. 2010;118(9):1326–31.CrossRef
13.
go back to reference Mishra V, Retherford RD, Smith KR. Cooking smoke and tobacco smoke as risk factors for stillbirth. Int J Environ Health Res. 2005;15(6):397–410.CrossRef Mishra V, Retherford RD, Smith KR. Cooking smoke and tobacco smoke as risk factors for stillbirth. Int J Environ Health Res. 2005;15(6):397–410.CrossRef
14.
go back to reference Clifford A, Lang L, Chen R, Anstey KJ, Seaton A. Exposure to air pollution and cognitive functioning across the life course--a systematic literature review. Environ Res. 2016;147:383–98.CrossRef Clifford A, Lang L, Chen R, Anstey KJ, Seaton A. Exposure to air pollution and cognitive functioning across the life course--a systematic literature review. Environ Res. 2016;147:383–98.CrossRef
15.
go back to reference Edmond K, Scott S, Korczak V, Ward C, Sanderson C, Theodoratou E, et al. Long term sequelae from childhood pneumonia; systematic review and meta-analysis. PLoS One. 2012;7(2):e31239.CrossRef Edmond K, Scott S, Korczak V, Ward C, Sanderson C, Theodoratou E, et al. Long term sequelae from childhood pneumonia; systematic review and meta-analysis. PLoS One. 2012;7(2):e31239.CrossRef
16.
go back to reference Martinez FD. Early-life origins of chronic obstructive pulmonary disease. N Engl J Med. 2016;375(9):871–8.CrossRef Martinez FD. Early-life origins of chronic obstructive pulmonary disease. N Engl J Med. 2016;375(9):871–8.CrossRef
17.
go back to reference Arlington L, Patel AB, Simmons E, Kurhe K, Prakash A, Rao SR, et al. Duration of solid fuel cookstove use is associated with increased risk of acute lower respiratory infection among children under six months in rural central India. PLoS One. 2019;14(10):e0224374.CrossRef Arlington L, Patel AB, Simmons E, Kurhe K, Prakash A, Rao SR, et al. Duration of solid fuel cookstove use is associated with increased risk of acute lower respiratory infection among children under six months in rural central India. PLoS One. 2019;14(10):e0224374.CrossRef
18.
go back to reference Bickton FM, Ndeketa L, Sibande GT, Nkeramahame J, Payesa C, Milanzi EB. Household air pollution and under-five mortality in sub-Saharan Africa: an analysis of 14 demographic and health surveys. Environ Health Prev Med. 2020;25(1):67.CrossRef Bickton FM, Ndeketa L, Sibande GT, Nkeramahame J, Payesa C, Milanzi EB. Household air pollution and under-five mortality in sub-Saharan Africa: an analysis of 14 demographic and health surveys. Environ Health Prev Med. 2020;25(1):67.CrossRef
19.
go back to reference Kurata M, Takahashi K, Hibiki A. Gender differences in associations of household and ambient air pollution with child health: evidence from household and satellite-based data in Bangladesh. World Dev. 2020;128:104779.CrossRef Kurata M, Takahashi K, Hibiki A. Gender differences in associations of household and ambient air pollution with child health: evidence from household and satellite-based data in Bangladesh. World Dev. 2020;128:104779.CrossRef
20.
go back to reference Lee AG, Kaali S, Quinn A, Delimini R, Burkart K, Opoku-Mensah J, et al. Prenatal household air pollution is associated with impaired infant lung function with sex-specific effects. Evidence from GRAPHS, a cluster randomized cookstove intervention trial. Am J Respir Crit Care Med. 2019;199(6):738–46.CrossRef Lee AG, Kaali S, Quinn A, Delimini R, Burkart K, Opoku-Mensah J, et al. Prenatal household air pollution is associated with impaired infant lung function with sex-specific effects. Evidence from GRAPHS, a cluster randomized cookstove intervention trial. Am J Respir Crit Care Med. 2019;199(6):738–46.CrossRef
21.
go back to reference Gurley ES, Salje H, Homaira N, Ram PK, Haque R, Petri WA Jr, et al. Seasonal concentrations and determinants of indoor particulate matter in a low-income community in Dhaka, Bangladesh. Environ Res. 2013;121(0):11–6.CrossRef Gurley ES, Salje H, Homaira N, Ram PK, Haque R, Petri WA Jr, et al. Seasonal concentrations and determinants of indoor particulate matter in a low-income community in Dhaka, Bangladesh. Environ Res. 2013;121(0):11–6.CrossRef
22.
go back to reference Perera FP, Rauh V, Whyatt RM, Tsai WY, Tang D, Diaz D, et al. Effect of prenatal exposure to airborne polycyclic aromatic hydrocarbons on neurodevelopment in the first 3 years of life among inner-city children. Environ Health Perspect. 2006;114(8):1287–92.CrossRef Perera FP, Rauh V, Whyatt RM, Tsai WY, Tang D, Diaz D, et al. Effect of prenatal exposure to airborne polycyclic aromatic hydrocarbons on neurodevelopment in the first 3 years of life among inner-city children. Environ Health Perspect. 2006;114(8):1287–92.CrossRef
23.
go back to reference Lertxundi A, Baccini M, Lertxundi N, Fano E, Aranbarri A, Martínez MD, et al. Exposure to fine particle matter, nitrogen dioxide and benzene during pregnancy and cognitive and psychomotor developments in children at 15 months of age. Environ Int. 2015;80:33–40.CrossRef Lertxundi A, Baccini M, Lertxundi N, Fano E, Aranbarri A, Martínez MD, et al. Exposure to fine particle matter, nitrogen dioxide and benzene during pregnancy and cognitive and psychomotor developments in children at 15 months of age. Environ Int. 2015;80:33–40.CrossRef
24.
go back to reference Raynes-Greenow C, Alam A, Billah SM, Islam S, Agho K, Rokonuzzaman SM, Thornburg J, El Arifeen S, Chowdhury AI; Poriborton Trial Team, Dibley MJ. Protocol for a cluster randomised controlled trial of LPG cookstoves compared to usual cooking practices to reduce perinatal mortality and morbidity in rural Bangladesh called Poriborton: the CHANge trial. Trials. 2022;23(1):325. https://doi.org/10.1186/s13063-022-06146-7. Raynes-Greenow C, Alam A, Billah SM, Islam S, Agho K, Rokonuzzaman SM, Thornburg J, El Arifeen S, Chowdhury AI; Poriborton Trial Team, Dibley MJ. Protocol for a cluster randomised controlled trial of LPG cookstoves compared to usual cooking practices to reduce perinatal mortality and morbidity in rural Bangladesh called Poriborton: the CHANge trial. Trials. 2022;23(1):325. https://​doi.​org/​10.​1186/​s13063-022-06146-7.
25.
go back to reference National Institute of Population Research and Training (NIPORT), and ICF. Bangladesh Demographic and Health Survey 2017-18: Key Indicators. Dhaka and Rockville: NIPORT, and ICF; 2019. National Institute of Population Research and Training (NIPORT), and ICF. Bangladesh Demographic and Health Survey 2017-18: Key Indicators. Dhaka and Rockville: NIPORT, and ICF; 2019.
26.
go back to reference Olney DK, Pedehombga A, Ruel MT, Dillon A. A 2-year integrated agriculture and nutrition and health behavior change communication program targeted to women in Burkina Faso reduces anemia, wasting, and diarrhea in children 3-12.9 months of age at baseline: a cluster-randomized controlled trial. J Nutr. 2015;145(6):1317–24.CrossRef Olney DK, Pedehombga A, Ruel MT, Dillon A. A 2-year integrated agriculture and nutrition and health behavior change communication program targeted to women in Burkina Faso reduces anemia, wasting, and diarrhea in children 3-12.9 months of age at baseline: a cluster-randomized controlled trial. J Nutr. 2015;145(6):1317–24.CrossRef
27.
go back to reference Lohman TG. Advances in body composition assessment: currentok issues in exercise science. Champaign: Human Kinetics Publishers; 1992. Lohman TG. Advances in body composition assessment: currentok issues in exercise science. Champaign: Human Kinetics Publishers; 1992.
28.
go back to reference World Health Organization. WHO child growth standards: length/height-for-age, weight-for-age, weight-for-length, weight-for forheight and body mass index-for-age: methods and development. In: Edited by Group WMGRS. Geneva: World Health Organization; 2006. World Health Organization. WHO child growth standards: length/height-for-age, weight-for-age, weight-for-length, weight-for forheight and body mass index-for-age: methods and development. In: Edited by Group WMGRS. Geneva: World Health Organization; 2006.
29.
go back to reference Hossain SJ, Roy BR, Salveen N-E, Hasan MI, Tipu SMMU, Shiraji S, et al. Effects of adding psychosocial stimulation for children of lactating mothers using an unconditional cash transfer platform on neurocognitive behavior of children in rural Bangladesh: protocol for a cluster randomized controlled trial. BMC Psychol. 2019;7(1):13.CrossRef Hossain SJ, Roy BR, Salveen N-E, Hasan MI, Tipu SMMU, Shiraji S, et al. Effects of adding psychosocial stimulation for children of lactating mothers using an unconditional cash transfer platform on neurocognitive behavior of children in rural Bangladesh: protocol for a cluster randomized controlled trial. BMC Psychol. 2019;7(1):13.CrossRef
30.
go back to reference Hamadani JD, Mehrin SF, Tofail F, Hasan MI, Huda SN, Baker-Henningham H, et al. Integrating an early childhood development programme into Bangladeshi primary health-care services: an open-label, cluster-randomised controlled trial. Lancet Glob Health. 2019;7(3):e366–75.CrossRef Hamadani JD, Mehrin SF, Tofail F, Hasan MI, Huda SN, Baker-Henningham H, et al. Integrating an early childhood development programme into Bangladeshi primary health-care services: an open-label, cluster-randomised controlled trial. Lancet Glob Health. 2019;7(3):e366–75.CrossRef
31.
go back to reference Billah SM, Ferdous TE, Karim MA, Dibley MJ, Raihana S, Moinuddin M, et al. A community-based cluster randomised controlled trial to evaluate the effectiveness of different bundles of nutrition-specific interventions in improving mean length-for-age z score among children at 24 months of age in rural Bangladesh: study protocol. BMC Public Health. 2017;17(1):375.CrossRef Billah SM, Ferdous TE, Karim MA, Dibley MJ, Raihana S, Moinuddin M, et al. A community-based cluster randomised controlled trial to evaluate the effectiveness of different bundles of nutrition-specific interventions in improving mean length-for-age z score among children at 24 months of age in rural Bangladesh: study protocol. BMC Public Health. 2017;17(1):375.CrossRef
32.
go back to reference National Institute of Population Research and Training (NIPORT), International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), and MEASURE Evaluation. Bangladesh District Level Socio-demographic and Health Care Utilization Indicators. Dhaka and Chapel Hill: NIPORT, icddr,b, and MEASURE Evaluation; 2019. National Institute of Population Research and Training (NIPORT), International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), and MEASURE Evaluation. Bangladesh District Level Socio-demographic and Health Care Utilization Indicators. Dhaka and Chapel Hill: NIPORT, icddr,b, and MEASURE Evaluation; 2019.
33.
go back to reference Hamadani JD, Tofail F, Hilaly A, Huda SN, Engle P, Grantham-McGregor SM. Use of family care indicators and their relationship with child development in Bangladesh. J Health Popul Nutr. 2010;28(1):23–33.CrossRef Hamadani JD, Tofail F, Hilaly A, Huda SN, Engle P, Grantham-McGregor SM. Use of family care indicators and their relationship with child development in Bangladesh. J Health Popul Nutr. 2010;28(1):23–33.CrossRef
34.
go back to reference World Food Programme, Vulnerability Analysis and Mapping Branch Food consumption analysis: calculation and use of the Food Consumption Score in food consumption and food security analysis. In: Technical guidance sheet. Version1. Rome: World Food Programme; 2008. World Food Programme, Vulnerability Analysis and Mapping Branch Food consumption analysis: calculation and use of the Food Consumption Score in food consumption and food security analysis. In: Technical guidance sheet. Version1. Rome: World Food Programme; 2008.
35.
go back to reference Coates J, Swindale A, Bilinsky P. Household Food Insecurity Access Scale (HFIAS) for measurement of household food access: indicator guide (v. 3); 2007. Coates J, Swindale A, Bilinsky P. Household Food Insecurity Access Scale (HFIAS) for measurement of household food access: indicator guide (v. 3); 2007.
36.
go back to reference Chang AB, et al. Use of management pathways or algorithms in children with chronic cough: CHEST guideline and expert panel report. Chest. 2017;151(4):875–83.CrossRef Chang AB, et al. Use of management pathways or algorithms in children with chronic cough: CHEST guideline and expert panel report. Chest. 2017;151(4):875–83.CrossRef
37.
go back to reference Homaira N, et al. Incidence of respiratory virus-associated pneumonia in urban poor young children of Dhaka, Bangladesh, 2009–2011. PLoS One. 2012;7(2):e32056.CrossRef Homaira N, et al. Incidence of respiratory virus-associated pneumonia in urban poor young children of Dhaka, Bangladesh, 2009–2011. PLoS One. 2012;7(2):e32056.CrossRef
38.
go back to reference Alam A, Tawale N, Patel A, Dibley MJ, Jadhao S, Raynes-Greenow C. Household air pollution intervention implications: findings from qualitative studies and a field trial of clean cookstoves in two rural villages in India. Int J Environ Res Public Health. 2016;13(9):893. Alam A, Tawale N, Patel A, Dibley MJ, Jadhao S, Raynes-Greenow C. Household air pollution intervention implications: findings from qualitative studies and a field trial of clean cookstoves in two rural villages in India. Int J Environ Res Public Health. 2016;13(9):893.
39.
go back to reference Chartier R, Phillips M, Mosquin P, Elledge M, Bronstein K, Nandasena S, et al. A comparative study of human exposures to household air pollution from commonly used cookstoves in Sri Lanka. Indoor Air. 2017:27(1):147-59. Chartier R, Phillips M, Mosquin P, Elledge M, Bronstein K, Nandasena S, et al. A comparative study of human exposures to household air pollution from commonly used cookstoves in Sri Lanka. Indoor Air. 2017:27(1):147-59.
40.
go back to reference Haddad Z, Williams KN, Lewis JJ, Prats EV, Adair-Rohani H. Expanding data is critical to assessing gendered impacts of household energy use. BMJ. 2021;375:n2273.CrossRef Haddad Z, Williams KN, Lewis JJ, Prats EV, Adair-Rohani H. Expanding data is critical to assessing gendered impacts of household energy use. BMJ. 2021;375:n2273.CrossRef
41.
go back to reference Malapit H, Quisumbing A, Meinzen-Dick R, Seymour G, Martinez EM, Heckert J, et al. Development of the project-level Women’s Empowerment in Agriculture Index (pro-WEAI). World Dev. 2019;122:675–92.CrossRef Malapit H, Quisumbing A, Meinzen-Dick R, Seymour G, Martinez EM, Heckert J, et al. Development of the project-level Women’s Empowerment in Agriculture Index (pro-WEAI). World Dev. 2019;122:675–92.CrossRef
43.
go back to reference Pagel C, Prost A, Lewycka S, Das S, Colbourn T, Mahapatra R, et al. Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications. Trials. 2011;12(1):151. Pagel C, Prost A, Lewycka S, Das S, Colbourn T, Mahapatra R, et al. Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications. Trials. 2011;12(1):151.
Metadata
Title
Reducing household air pollution exposure to improve early child growth and development; a randomized control trial protocol for the “Poriborton-Extension: The CHANge trial”
Authors
Camille Raynes-Greenow
Sk Masum Billah
Sajia Islam
S. M. Rokonuzzaman
Fahmida Tofail
Elizabeth K. Kirkwood
Ashraful Alam
Ryan Chartier
Tarana E. Ferdous
Shams El Arifeen
Michael J. Dibley
Nusrat Homaira
Alison Hayes
Jonathan Thornburg
Patrick Kelly
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06342-5

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue