A cluster randomised trial of cookstove interventions to improve infant health in Ghana

BMJ Global Health, Volume 6, No. 8, Year 2021

Interprétation

Introduction Household air pollution from solid fuel combustion for cooking and heating is a leading cause of childhood morbidity and mortality worldwide. We hypothesised that clean cooking interventions delivered during pregnancy would improve child health. Methods We conducted a cluster randomised trial in rural Ghana to test whether providing pregnant women liquefied petroleum gas (LPG) cookstoves or improved biomass cookstoves would reduce personal carbon monoxide and fine particulate pollution exposure, increase birth weight and reduce physician-assessed severe pneumonia in the first 12 months of life, compared with control participants who continued to cook with traditional stoves. Primary analyses were intention-to-treat. The trial was registered with ClinicalTrials.gov and follow-up is complete. Results Enrolment began on 14 April 2014, and ended on 20 August 2015. We enrolled 1414 pregnant women; 361 in the LPG arm, 527 in the improved biomass cookstove arm and 526 controls. We saw no improvement in birth weight (the difference in mean birth weight for LPG arm births was 29 g lighter (95% CI-113 to 56, p=0.51) and for improved biomass arm births was 9 g heavier (95% CI-64 to 82, p=0.81), compared with control newborns) nor severe child pneumonia (the rate ratio for pneumonia in the LPG arm was 0.98 (95% CI 0.58 to 1.70; p=0.95) and for the improved biomass arm was 1.21 (95% CI 0.78 to 1.90; p=0.52), compared with the control arm). Air pollution exposures in the LPG arm remained above WHO health-based targets (LPG median particulate matter less than 2.5 microns in diameter (PM 2.5) 45 μg/m3; IQR 32-65 vs control median PM 2.5 67 μg/m 3;, IQR 46-97). Conclusions Neither prenatally-introduced LPG nor improved biomass cookstoves improved birth weight or reduced severe pneumonia risk in the first 12 months of life. We hypothesise that this is due to lower-than-expected exposure reductions in the intervention arms. Thirty-five communities were randomised into three study arms (LPG, improved biomass stove and control). These communities comprised all population centres in the Kintampo North and South districts of Ghana. Pilot studies established the feasibility of study procedures and demonstrated that intervention cookstoves were capable of reducing exposure in controlled settings. Randomisation at the level of the community was carried out using a coarsened exact matching procedure and was implemented by an independent statistician.10 11 The study implementation team learnt of community study arm allocation after all study personnel were recruited and assigned to their respective clusters. Given the cluster-randomised nature of the design and the highly visible nature of the intervention, potentially eligible women knew their intervention status at the time of recruitment. The trial was implemented by a team from the KHRC and Columbia University. The trial was undertaken in accordance with the Declaration of Helsinki. The protocol was registered with ClinicalTrials.gov, and has been previously published.12 The trial was funded by the National Institutes of Health, the Global Alliance for Clean Cookstoves (now known as the Clean Cooking Alliance) and the Thrasher Research Fund. The funders played no role in study design, collection, analysis and interpretation of data, nor manuscript preparation. All of the authors vouch for adherence to trial protocol, completeness and veracity of data and analyses presented. All of the pregnant women provided written informed consent for their and their child’s study participation. Anonymised participant data are available on request. No significant changes to methods were made after study commencement. The selection of the intervention cookstoves was developed through extensive piloting and engagement with members of the communities where GRAPHS took place. Community members also provided feedback on exposure assessment procedures. Awareness about the health risks of HAP is not widespread in our study communities, so we did not involve study participants in the choice of outcome measures. Results of the study have been shared in community meetings, and the investigator team is engaged in ongoing research addressing household energy policy in Ghana. The great majority of households in the study region farm for a living and cook with solid fuels. Wood was by far the dominant fuel at baseline, with 1334 out of 1414 participants reporting wood as their primary fuel. The balance reported charcoal as the primary fuel (n=56) or had missing data (n=9). About half of the study participants (669 out of 1414) reported using charcoal as a secondary fuel, and 26 households reported crop residue as secondary. The balance of households reported no secondary fuel use. Fuel use patterns did not differ significantly across study arms. We did not observe any LPG, kerosene or electric cooking at baseline. Low birth weight and respiratory infections are public health concerns in the region.13 Solid fuel use has remained stable over time in rural areas in Ghana, and we observed no changes in cooking practices in our control group or in non-intervention households in intervention communities. Fieldworkers carried out pregnancy surveillance in each study community and referred pregnant women to trained midwives for confirmation of pregnancy and establishment of gestational age by transabdominal ultrasound (SonoSite S180). Study midwives underwent intensive pre-trial ultrasound training and ongoing image review and quality control by a US-based obstetrician during the study as previously described.14 Pregnant individuals were eligible to be enrolled if they were the primary cook in their household; were pregnant with a live, intrauterine fetus; were ≤24 weeks gestation (to allow for delivery of intervention by 28 weeks at the latest); and were non-smokers. Women with a multiple gestation identified at the time of the screening ultrasound were excluded. Detailed eligibility criteria and screening procedures are available in the study protocol.12 Essentially all households in our study area relied primarily on solid fuels for cooking, so we did not screen for cooking fuel at enrolment.15 Communities were assigned to one of two cookstove interventions or to the control arm (online supplemental figure 1). All enrolled participants received a mosquito bed net and health insurance. In the LPG intervention arm, participants received a two-burner LPG cookstove (Ghana Cylinder Manufacturing Company, Accra, Ghana), two 14.5 kg LPG cylinders, and monthly LPG deliveries for the duration of study enrolment at no cost to study participants. Additional LPG fuel was available as needed. In the improved biomass stove arm, participants received two single-burner BioLite HomeStove forced draft wood fuel cookstoves (BioLite, Brooklyn, New York, USA). The improved biomass stove reduces emissions via a thermoelectric-powered fan, which blows air into the combustion chamber to improve combustion efficiency, and stove geometry, which increases heat transfer efficiency. The BioLite has a side opening for fuel, and thus can accommodate wood fuels similar to those used in the traditional three-stone fires with minimal differences in processing. BioLite stoves are not suitable for burning charcoal or crop residue. Control participants continued to cook with the traditional biomass stoves and fuels. Fieldworkers encouraged intervention cookstove use, checked stove condition and conducted maintenance and repairs as necessary during weekly visits with each participant. Similar visits to the control participants were framed as bed net visits. Participants remained on study from enrolment through the end of the child’s first year of life or until the end of surveillance in March 2016. On study completion, participants in the control and BioLite arms received a two-burner LPG cookstove and two 14.5 kg LPG cylinders. bmjgh-2021-005599supp001.pdf The co-primary endpoints of the trial were birth weight among liveborn infants born at 28 weeks or later gestational age; and physician-assessed severe pneumonia in the first 12 months of life as defined in the WHO Integrated Management of Childhood Illnesses handbook (IMCI).16 Secondary trial birth endpoints included birth length and head circumference, preterm birth (defined as ≥28 and <37 completed weeks gestation at delivery), low birth weight (defined as birth weight <2500 g) and small for gestational age (defined as <10th percentile for gestational age)17 (see online supplemental material for detailed definitions). Secondary trial pneumonia endpoints included physician-diagnosed pneumonia and a composite outcome of fieldworker-diagnosed and physician-diagnosed pneumonia and severe pneumonia (again using IMCI definitions). Community-based fieldworkers measured birth anthropometrics within 24 hours of birth at the place of delivery (home or facility). Birth weight was measured to the nearest 0.01 kg (Tanita digital scale model BD-590, Tanita, Illinois, USA) after standardising the scale to a 1 kg weight. Birth weight was considered missing if the fieldworkers were unable to measure birth weight within 72 hours of birth. Birth length was measured with use of the Ayrton Infantometer Model M-200 (Ayrton, Minnesota, USA) and recorded to the nearest 0.1 cm and head circumference measured to the nearest 0.1 cm using a paper tape (a ‘lasso’) from the Child Growth Foundation in London. Pneumonia surveillance involved active (weekly fieldworker surveillance) and passive (self-referral) methods. Community-based fieldworkers trained in the IMCI guidelines made weekly home visits to identify potential pneumonia cases. The IMCI defines pneumonia as cough or difficulty breathing plus elevated respiratory rate (60 breaths/min in children aged 0–2 months (56 days) or 50 breaths/min in children aged 2–12 months). Severe pneumonia was defined as pneumonia in a child less than 2 months of age or pneumonia plus the presence of oxygen saturation of less than 90% as measured by pulse oximetry, chest wall indrawing, stridor or any general danger sign (including convulsions, vomiting or inability to drink or breast feed, lethargy or unconsciousness). Any child with fieldworker-diagnosed pneumonia, or who was otherwise unwell, was brought to a central medical clinic for physician evaluation. Community-based fieldworkers also facilitated self-referrals any time a parent felt that their child was ill. The study provided transportation and paid for incidental expenses related to all clinical visits. At the central clinic, study physicians trained in IMCI guidelines diagnosed pneumonia and severe pneumonia. The primary pneumonia outcome was physician-diagnosed severe pneumonia, without the use of chest radiograph or ultrasound. Due to the visible nature of the intervention, fieldworkers were not blinded to study intervention arm. Physicians examined study children at a central clinic and were unaware of study intervention assignment. Study physicians immediately began treatment for pneumonia or other diagnosed illness, including hospital admission where appropriate. As with prior studies,4 children were not considered to have a new pneumonia episode if a repeat diagnosis occurred within 21 days of a prior pneumonia episode. If the initial assessment diagnosed pneumonia and a repeat assessment within 21 days diagnosed severe pneumonia, the pneumonia episode was reclassified as severe. The secondary composite pneumonia outcome of fieldworker-diagnosed and physician-diagnosed pneumonia included physician-assessed pneumonia cases as described above in addition to fieldworker-assessed pneumonia cases where the child did not receive study physician assessment within 7 days of fieldworker assessment. In cases where a fieldworker diagnosis and subsequent physician diagnosis occurring within 7 days did not agree (eg, the fieldworker-diagnosed pneumonia and the physician did not), the physician diagnosis was used. We measured 72-hour personal exposures to carbon monoxide (CO) using Lascar EL-USB-CO sensors (Lascar Electronics, Erie, Pennsylvania, USA) and to particulate matter less than 2.5 microns in diameter (PM2.5) using microPEM monitors (RTI, Research Triangle Park, North Carolina, USA). Antenatal CO monitoring occurred at enrolment prior to deployment of intervention cookstove, 3 weeks after intervention cookstove deployment, and at two additional time points evenly spaced over the remaining antenatal period. Postnatal CO monitoring of both the child and the mother took place 1, 3 and 9 months post partum. We measured PM2.5 in a subset of adult study participants during the second CO session (prenatally, 3 weeks post enrolment) and/or postnatally at child age 3 months. Budget limitations dictated the PM2.5 sample. Exposure assessment methods and results have been previously published.18 Maternal age, parity and medical history were assessed at enrolment through questionnaires. Maternal height and weight were measured on enrolment and used to determine maternal body mass index (BMI). Enrolment questionnaires determining household assets were used to construct an asset index as a proxy for wealth (see online supplemental material). Weekly fieldworker visits from enrolment through delivery captured the number of antenatal visits. Infant sex and date of delivery were recorded at birth. Fieldworkers and physicians recorded dates of pneumonia assessments which were used to determine month of pneumonia and age of child at the time of pneumonia diagnosis. At each prenatal and postnatal fieldworker visit, continued use of intervention cookstove was assessed via questionnaire. Power calculations for GRAPHS have been previously published.12 The estimated sample size was 1415 pregnant women, with randomisation yielding 365 participants in the LPG arm (across 9 clusters), 525 participants in the improved biomass arm (across 13 clusters) and 525 participants in the control arm (across 13 clusters). For the birth weight outcome, sample size calculations were based on estimated effect sizes (Cohen’s D) of 0.32 for the improved biomass arm and 0.40 for the LPG arm,19 20 15% attrition and a two-sided type 1 error rate of 5%. We estimated that 1415 enrolled pregnancies would yield 1225 participants reaching age 1. For pneumonia, we used an effect size derived from work in the Gambia,21 and, with the same attrition and type 1 error rate as above, computed power of 0.98 for the LPG arm, and 0.89 for the improved biomass arm. Primary analyses were performed according to the intention-to-treat principle. First, we used linear regression models to assess differences in birth weight by study arm. Cluster-robust SE estimates (at the village level) were employed to account for the cluster-randomised nature of the intervention deployment. We additionally conducted secondary analyses that included adjustment for asset index; maternal BMI, age and parity; number of antenatal care visits dichotomised around the median (four visits); and infant sex. Additional continuous birth outcomes (head circumference, birth length and gestational age at delivery) were analysed in the same manner as birth weight. Categorical birth outcomes (preterm birth, low birth weight, small-for-gestational-age and neonatal death occurring within 7 days of birth) were analysed using modified Poisson regressions with robust SE using the ‘sandwich’ estimator. Any infant born alive and with at least one fieldworker pneumonia surveillance visit was included in the pneumonia analyses. Primary pneumonia analyses were performed according to the intention-to-treat principle. We employed generalised estimating equation (GEE) logistic regression models with exchangeable correlation structure and cluster-robust SE estimates to assess the difference in incidence of physician-assessed severe pneumonia in the first year of life per child-days. GEE was used to account for both multiple episodes within a child and the village-level intervention deployment.22 Secondary analyses adjusted for an asset index, month of delivery, month of pneumonia event, child sex and child age. These same models were used to examine the effect of cookstove intervention on physician-assessed pneumonia and composite outcomes of fieldworker-assessed and physician-assessed pneumonia and severe pneumonia. We additionally conducted survival analyses using Cox proportional-hazard models for the time to the first incident of physician-diagnosed severe pneumonia, pneumonia or composite pneumonia outcomes, considered separately, to examine group differences in the risk, with and without adjustment of child sex, month of delivery and an asset index. HRs for group comparisons were derived from estimated model parameters, and their CIs were based on robust sandwich estimate of variance of parameter estimates to account for possible within-cluster (village) correlation among the children. Analyses were carried out in R V.3.6.0 and SAS V.9.4. The funder of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Résumé de l’IA

Study Justification:

The study aimed to investigate whether providing pregnant women in rural Ghana with clean cooking interventions, such as liquefied petroleum gas (LPG) cookstoves or improved biomass cookstoves, would reduce their exposure to household air pollution (HAP) and improve infant health outcomes. HAP from solid fuel combustion for cooking and heating is a major cause of childhood morbidity and mortality worldwide. The study aimed to address this issue and provide evidence for effective interventions to improve infant health.

Highlights:

– The study enrolled 1414 pregnant women in 35 communities in rural Ghana.
– The participants were divided into three study arms: LPG cookstove intervention, improved biomass cookstove intervention, and control group (traditional stoves).
– The primary outcomes measured were birth weight and physician-assessed severe pneumonia in the first 12 months of life.
– The study found no significant improvement in birth weight or reduction in severe pneumonia risk in the intervention arms compared to the control group.
– Air pollution exposures in the LPG arm remained above World Health Organization (WHO) health-based targets.

Recommendations:

Based on the study findings, the following recommendations can be made:

1. Further research: Conduct additional research to explore other interventions or combinations of interventions that may effectively reduce HAP exposure and improve infant health outcomes.
2. Awareness and education: Increase awareness and education about the health risks of HAP in the study communities to promote behavior change and adoption of cleaner cooking practices.
3. Policy development: Develop and implement policies that promote the use of clean cooking technologies and provide support for their adoption, especially among vulnerable populations.
4. Access to clean fuels: Improve access to clean fuels, such as LPG, in rural areas to facilitate the transition from traditional solid fuel cooking methods.

Key Role Players:

To address the recommendations, the following key role players are needed:

1. Researchers and scientists: Conduct further research to explore effective interventions and evaluate their impact on infant health.
2. Government agencies: Develop and implement policies to promote clean cooking technologies and ensure access to clean fuels in rural areas.
3. Non-governmental organizations (NGOs): Collaborate with communities to raise awareness, provide education, and support the adoption of clean cooking practices.
4. Community leaders and influencers: Engage community leaders and influencers to promote behavior change and encourage the use of clean cooking technologies.

Cost Items for Planning Recommendations:

While the actual cost may vary, the following cost items should be considered in planning the recommendations:

1. Research funding: Allocate funds for further research, including study design, data collection, analysis, and publication.
2. Policy development and implementation: Allocate resources for policy development, stakeholder engagement, and monitoring and evaluation of policy implementation.
3. Awareness and education campaigns: Allocate funds for community outreach, training programs, and materials to raise awareness about the health risks of HAP and promote behavior change.
4. Access to clean fuels: Allocate resources for infrastructure development, distribution networks, and subsidies to improve access to clean fuels in rural areas.
Please note that the provided information is based on the description of the study and may not include all details or nuances.

Force de la preuve

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is moderately strong. The study design is a cluster randomized trial, which is a robust method. The trial was registered with ClinicalTrials.gov and follow-up is complete. The study enrolled a large number of pregnant women (1414) and collected data on birth weight and severe pneumonia in the first 12 months of life. However, the results showed no improvement in birth weight or severe pneumonia in the intervention arms compared to the control arm. The authors hypothesize that this is due to lower-than-expected exposure reductions in the intervention arms. To improve the strength of the evidence, future studies could consider increasing the sample size, ensuring better compliance with the intervention, and conducting a longer follow-up period to assess long-term effects.

Abstrait

Thirty-five communities were randomised into three study arms (LPG, improved biomass stove and control). These communities comprised all population centres in the Kintampo North and South districts of Ghana. Pilot studies established the feasibility of study procedures and demonstrated that intervention cookstoves were capable of reducing exposure in controlled settings. Randomisation at the level of the community was carried out using a coarsened exact matching procedure and was implemented by an independent statistician.10 11 The study implementation team learnt of community study arm allocation after all study personnel were recruited and assigned to their respective clusters. Given the cluster-randomised nature of the design and the highly visible nature of the intervention, potentially eligible women knew their intervention status at the time of recruitment. The trial was implemented by a team from the KHRC and Columbia University. The trial was undertaken in accordance with the Declaration of Helsinki. The protocol was registered with ClinicalTrials.gov, and has been previously published.12 The trial was funded by the National Institutes of Health, the Global Alliance for Clean Cookstoves (now known as the Clean Cooking Alliance) and the Thrasher Research Fund. The funders played no role in study design, collection, analysis and interpretation of data, nor manuscript preparation. All of the authors vouch for adherence to trial protocol, completeness and veracity of data and analyses presented. All of the pregnant women provided written informed consent for their and their child’s study participation. Anonymised participant data are available on request. No significant changes to methods were made after study commencement. The selection of the intervention cookstoves was developed through extensive piloting and engagement with members of the communities where GRAPHS took place. Community members also provided feedback on exposure assessment procedures. Awareness about the health risks of HAP is not widespread in our study communities, so we did not involve study participants in the choice of outcome measures. Results of the study have been shared in community meetings, and the investigator team is engaged in ongoing research addressing household energy policy in Ghana. The great majority of households in the study region farm for a living and cook with solid fuels. Wood was by far the dominant fuel at baseline, with 1334 out of 1414 participants reporting wood as their primary fuel. The balance reported charcoal as the primary fuel (n=56) or had missing data (n=9). About half of the study participants (669 out of 1414) reported using charcoal as a secondary fuel, and 26 households reported crop residue as secondary. The balance of households reported no secondary fuel use. Fuel use patterns did not differ significantly across study arms. We did not observe any LPG, kerosene or electric cooking at baseline. Low birth weight and respiratory infections are public health concerns in the region.13 Solid fuel use has remained stable over time in rural areas in Ghana, and we observed no changes in cooking practices in our control group or in non-intervention households in intervention communities. Fieldworkers carried out pregnancy surveillance in each study community and referred pregnant women to trained midwives for confirmation of pregnancy and establishment of gestational age by transabdominal ultrasound (SonoSite S180). Study midwives underwent intensive pre-trial ultrasound training and ongoing image review and quality control by a US-based obstetrician during the study as previously described.14 Pregnant individuals were eligible to be enrolled if they were the primary cook in their household; were pregnant with a live, intrauterine fetus; were ≤24 weeks gestation (to allow for delivery of intervention by 28 weeks at the latest); and were non-smokers. Women with a multiple gestation identified at the time of the screening ultrasound were excluded. Detailed eligibility criteria and screening procedures are available in the study protocol.12 Essentially all households in our study area relied primarily on solid fuels for cooking, so we did not screen for cooking fuel at enrolment.15 Communities were assigned to one of two cookstove interventions or to the control arm (online supplemental figure 1). All enrolled participants received a mosquito bed net and health insurance. In the LPG intervention arm, participants received a two-burner LPG cookstove (Ghana Cylinder Manufacturing Company, Accra, Ghana), two 14.5 kg LPG cylinders, and monthly LPG deliveries for the duration of study enrolment at no cost to study participants. Additional LPG fuel was available as needed. In the improved biomass stove arm, participants received two single-burner BioLite HomeStove forced draft wood fuel cookstoves (BioLite, Brooklyn, New York, USA). The improved biomass stove reduces emissions via a thermoelectric-powered fan, which blows air into the combustion chamber to improve combustion efficiency, and stove geometry, which increases heat transfer efficiency. The BioLite has a side opening for fuel, and thus can accommodate wood fuels similar to those used in the traditional three-stone fires with minimal differences in processing. BioLite stoves are not suitable for burning charcoal or crop residue. Control participants continued to cook with the traditional biomass stoves and fuels. Fieldworkers encouraged intervention cookstove use, checked stove condition and conducted maintenance and repairs as necessary during weekly visits with each participant. Similar visits to the control participants were framed as bed net visits. Participants remained on study from enrolment through the end of the child’s first year of life or until the end of surveillance in March 2016. On study completion, participants in the control and BioLite arms received a two-burner LPG cookstove and two 14.5 kg LPG cylinders. bmjgh-2021-005599supp001.pdf The co-primary endpoints of the trial were birth weight among liveborn infants born at 28 weeks or later gestational age; and physician-assessed severe pneumonia in the first 12 months of life as defined in the WHO Integrated Management of Childhood Illnesses handbook (IMCI).16 Secondary trial birth endpoints included birth length and head circumference, preterm birth (defined as ≥28 and <37 completed weeks gestation at delivery), low birth weight (defined as birth weight <2500 g) and small for gestational age (defined as <10th percentile for gestational age)17 (see online supplemental material for detailed definitions). Secondary trial pneumonia endpoints included physician-diagnosed pneumonia and a composite outcome of fieldworker-diagnosed and physician-diagnosed pneumonia and severe pneumonia (again using IMCI definitions). Community-based fieldworkers measured birth anthropometrics within 24 hours of birth at the place of delivery (home or facility). Birth weight was measured to the nearest 0.01 kg (Tanita digital scale model BD-590, Tanita, Illinois, USA) after standardising the scale to a 1 kg weight. Birth weight was considered missing if the fieldworkers were unable to measure birth weight within 72 hours of birth. Birth length was measured with use of the Ayrton Infantometer Model M-200 (Ayrton, Minnesota, USA) and recorded to the nearest 0.1 cm and head circumference measured to the nearest 0.1 cm using a paper tape (a ‘lasso’) from the Child Growth Foundation in London. Pneumonia surveillance involved active (weekly fieldworker surveillance) and passive (self-referral) methods. Community-based fieldworkers trained in the IMCI guidelines made weekly home visits to identify potential pneumonia cases. The IMCI defines pneumonia as cough or difficulty breathing plus elevated respiratory rate (60 breaths/min in children aged 0–2 months (56 days) or 50 breaths/min in children aged 2–12 months). Severe pneumonia was defined as pneumonia in a child less than 2 months of age or pneumonia plus the presence of oxygen saturation of less than 90% as measured by pulse oximetry, chest wall indrawing, stridor or any general danger sign (including convulsions, vomiting or inability to drink or breast feed, lethargy or unconsciousness). Any child with fieldworker-diagnosed pneumonia, or who was otherwise unwell, was brought to a central medical clinic for physician evaluation. Community-based fieldworkers also facilitated self-referrals any time a parent felt that their child was ill. The study provided transportation and paid for incidental expenses related to all clinical visits. At the central clinic, study physicians trained in IMCI guidelines diagnosed pneumonia and severe pneumonia. The primary pneumonia outcome was physician-diagnosed severe pneumonia, without the use of chest radiograph or ultrasound. Due to the visible nature of the intervention, fieldworkers were not blinded to study intervention arm. Physicians examined study children at a central clinic and were unaware of study intervention assignment. Study physicians immediately began treatment for pneumonia or other diagnosed illness, including hospital admission where appropriate. As with prior studies,4 children were not considered to have a new pneumonia episode if a repeat diagnosis occurred within 21 days of a prior pneumonia episode. If the initial assessment diagnosed pneumonia and a repeat assessment within 21 days diagnosed severe pneumonia, the pneumonia episode was reclassified as severe. The secondary composite pneumonia outcome of fieldworker-diagnosed and physician-diagnosed pneumonia included physician-assessed pneumonia cases as described above in addition to fieldworker-assessed pneumonia cases where the child did not receive study physician assessment within 7 days of fieldworker assessment. In cases where a fieldworker diagnosis and subsequent physician diagnosis occurring within 7 days did not agree (eg, the fieldworker-diagnosed pneumonia and the physician did not), the physician diagnosis was used. We measured 72-hour personal exposures to carbon monoxide (CO) using Lascar EL-USB-CO sensors (Lascar Electronics, Erie, Pennsylvania, USA) and to particulate matter less than 2.5 microns in diameter (PM2.5) using microPEM monitors (RTI, Research Triangle Park, North Carolina, USA). Antenatal CO monitoring occurred at enrolment prior to deployment of intervention cookstove, 3 weeks after intervention cookstove deployment, and at two additional time points evenly spaced over the remaining antenatal period. Postnatal CO monitoring of both the child and the mother took place 1, 3 and 9 months post partum. We measured PM2.5 in a subset of adult study participants during the second CO session (prenatally, 3 weeks post enrolment) and/or postnatally at child age 3 months. Budget limitations dictated the PM2.5 sample. Exposure assessment methods and results have been previously published.18 Maternal age, parity and medical history were assessed at enrolment through questionnaires. Maternal height and weight were measured on enrolment and used to determine maternal body mass index (BMI). Enrolment questionnaires determining household assets were used to construct an asset index as a proxy for wealth (see online supplemental material). Weekly fieldworker visits from enrolment through delivery captured the number of antenatal visits. Infant sex and date of delivery were recorded at birth. Fieldworkers and physicians recorded dates of pneumonia assessments which were used to determine month of pneumonia and age of child at the time of pneumonia diagnosis. At each prenatal and postnatal fieldworker visit, continued use of intervention cookstove was assessed via questionnaire. Power calculations for GRAPHS have been previously published.12 The estimated sample size was 1415 pregnant women, with randomisation yielding 365 participants in the LPG arm (across 9 clusters), 525 participants in the improved biomass arm (across 13 clusters) and 525 participants in the control arm (across 13 clusters). For the birth weight outcome, sample size calculations were based on estimated effect sizes (Cohen’s D) of 0.32 for the improved biomass arm and 0.40 for the LPG arm,19 20 15% attrition and a two-sided type 1 error rate of 5%. We estimated that 1415 enrolled pregnancies would yield 1225 participants reaching age 1. For pneumonia, we used an effect size derived from work in the Gambia,21 and, with the same attrition and type 1 error rate as above, computed power of 0.98 for the LPG arm, and 0.89 for the improved biomass arm. Primary analyses were performed according to the intention-to-treat principle. First, we used linear regression models to assess differences in birth weight by study arm. Cluster-robust SE estimates (at the village level) were employed to account for the cluster-randomised nature of the intervention deployment. We additionally conducted secondary analyses that included adjustment for asset index; maternal BMI, age and parity; number of antenatal care visits dichotomised around the median (four visits); and infant sex. Additional continuous birth outcomes (head circumference, birth length and gestational age at delivery) were analysed in the same manner as birth weight. Categorical birth outcomes (preterm birth, low birth weight, small-for-gestational-age and neonatal death occurring within 7 days of birth) were analysed using modified Poisson regressions with robust SE using the ‘sandwich’ estimator. Any infant born alive and with at least one fieldworker pneumonia surveillance visit was included in the pneumonia analyses. Primary pneumonia analyses were performed according to the intention-to-treat principle. We employed generalised estimating equation (GEE) logistic regression models with exchangeable correlation structure and cluster-robust SE estimates to assess the difference in incidence of physician-assessed severe pneumonia in the first year of life per child-days. GEE was used to account for both multiple episodes within a child and the village-level intervention deployment.22 Secondary analyses adjusted for an asset index, month of delivery, month of pneumonia event, child sex and child age. These same models were used to examine the effect of cookstove intervention on physician-assessed pneumonia and composite outcomes of fieldworker-assessed and physician-assessed pneumonia and severe pneumonia. We additionally conducted survival analyses using Cox proportional-hazard models for the time to the first incident of physician-diagnosed severe pneumonia, pneumonia or composite pneumonia outcomes, considered separately, to examine group differences in the risk, with and without adjustment of child sex, month of delivery and an asset index. HRs for group comparisons were derived from estimated model parameters, and their CIs were based on robust sandwich estimate of variance of parameter estimates to account for possible within-cluster (village) correlation among the children. Analyses were carried out in R V.3.6.0 and SAS V.9.4. The funder of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Matériaux

N/A

Innovations

The innovation described in the study is the implementation of clean cooking interventions during pregnancy to improve child health. The study tested the effectiveness of providing pregnant women with liquefied petroleum gas (LPG) cookstoves or improved biomass cookstoves in reducing personal carbon monoxide and fine particulate pollution exposure, increasing birth weight, and reducing severe pneumonia in infants.

However, the study found no improvement in birth weight or severe pneumonia risk in the intervention groups compared to the control group. The exposure to air pollution in the LPG arm remained above WHO health-based targets.

In terms of potential recommendations to improve access to maternal health, here are a few innovations that could be considered:

1. Increase awareness: Implement education and awareness campaigns to inform pregnant women and their communities about the importance of clean cooking practices and the health risks associated with household air pollution.

2. Subsidies or financial incentives: Provide financial support or incentives to pregnant women to encourage the adoption of clean cooking technologies, such as LPG cookstoves or improved biomass cookstoves. This could help overcome the cost barrier associated with purchasing these technologies.

3. Distribution networks: Establish efficient distribution networks to ensure the availability and accessibility of clean cooking technologies in rural areas. This could involve working with local retailers, community organizations, or government agencies to make these technologies easily accessible to pregnant women.

4. Training and capacity building: Provide training and capacity building programs for healthcare providers, community health workers, and midwives on the importance of clean cooking practices and how to educate and support pregnant women in adopting these practices.

5. Research and development: Invest in research and development to improve the design and effectiveness of clean cooking technologies specifically tailored for pregnant women. This could involve exploring innovative solutions, such as portable or affordable clean cooking options that are suitable for use during pregnancy.

It’s important to note that these recommendations are based on the context of the study and may need to be adapted to specific regional or cultural factors.

AI Innovations Description

The study described is a cluster randomized trial conducted in rural Ghana to test whether providing pregnant women with clean cooking interventions would improve child health. The interventions included providing pregnant women with either liquefied petroleum gas (LPG) cookstoves or improved biomass cookstoves. The goal was to reduce personal carbon monoxide and fine particulate pollution exposure, increase birth weight, and reduce severe pneumonia in infants.

However, the study found that neither the LPG nor the improved biomass cookstoves improved birth weight or reduced severe pneumonia risk in the first 12 months of life. The researchers hypothesized that this lack of improvement may be due to lower-than-expected exposure reductions in the intervention arms.

The study enrolled 1414 pregnant women, with 361 in the LPG arm, 527 in the improved biomass cookstove arm, and 526 in the control group. The primary outcomes measured were birth weight and physician-assessed severe pneumonia in the first 12 months of life. Secondary outcomes included birth length, head circumference, preterm birth, low birth weight, and small for gestational age.

The study used cluster randomization, with 35 communities randomized into three study arms. The randomization was carried out using a coarsened exact matching procedure, and the allocation was implemented by an independent statistician. The study was conducted in accordance with the Declaration of Helsinki and was registered with ClinicalTrials.gov.

The study was funded by the National Institutes of Health, the Global Alliance for Clean Cookstoves (now known as the Clean Cooking Alliance), and the Thrasher Research Fund. The funders had no role in the study design, data collection, analysis, interpretation, or manuscript preparation.

In conclusion, the study did not find any improvement in birth weight or reduction in severe pneumonia risk in infants when providing pregnant women with clean cooking interventions. The researchers suggest that further research is needed to understand the reasons for the lack of improvement and to develop more effective interventions to improve access to maternal health.

AI Innovations Methodology

The study described is focused on improving infant health by addressing household air pollution from solid fuel combustion for cooking and heating in rural Ghana. The researchers conducted a cluster randomized trial to test the effectiveness of providing pregnant women with liquefied petroleum gas (LPG) cookstoves or improved biomass cookstoves in reducing exposure to carbon monoxide and fine particulate pollution, increasing birth weight, and reducing severe pneumonia in infants.

However, the study found no improvement in birth weight or reduction in severe pneumonia risk in the intervention arms compared to the control group. The researchers hypothesized that this lack of improvement may be due to lower-than-expected exposure reductions in the intervention arms.

To simulate the impact of recommendations on improving access to maternal health, a methodology could be developed based on the following steps:

1. Identify the specific recommendations: Based on the study findings and other relevant research, identify the specific recommendations that could potentially improve access to maternal health. These recommendations could include interventions to reduce household air pollution, improve prenatal care, enhance healthcare infrastructure, or increase awareness about maternal health issues.

2. Define the indicators: Determine the indicators that will be used to measure the impact of the recommendations on improving access to maternal health. These indicators could include maternal mortality rates, birth outcomes, access to prenatal care, or other relevant measures.

3. Collect baseline data: Gather baseline data on the current state of maternal health in the target population. This could involve collecting information on maternal mortality rates, birth outcomes, healthcare utilization, and other relevant data.

4. Develop a simulation model: Create a simulation model that incorporates the baseline data, the identified recommendations, and the defined indicators. The model should simulate the impact of implementing the recommendations on the selected indicators.

5. Run simulations: Run the simulation model using different scenarios to assess the potential impact of the recommendations on improving access to maternal health. This could involve varying the implementation strategies, resource allocation, or other relevant factors.

6. Analyze results: Analyze the results of the simulations to determine the potential impact of the recommendations on improving access to maternal health. This could involve comparing the outcomes of different scenarios and identifying the most effective strategies.

7. Refine and validate the model: Refine the simulation model based on feedback and validation from experts in the field of maternal health. Ensure that the model accurately represents the dynamics of the target population and the potential impact of the recommendations.

8. Communicate findings: Present the findings of the simulation study to stakeholders, policymakers, and other relevant parties. Use the results to inform decision-making and advocate for the implementation of the recommendations that have the greatest potential for improving access to maternal health.

By following this methodology, researchers and policymakers can gain insights into the potential impact of recommendations on improving access to maternal health and make informed decisions about interventions and strategies to address this important issue.

Auteur

Dima Health

Statistics:

Citations: 12

Identifiers:

DOI: 10.1136/bmjgh-2021-005599

Research Areas:

Community Interventions, Environmental, Health System and Policy, Maternal Access, Maternal and Child Health, Quality of Care, Sexual and Reproductive Health, Social Determinants, Workforce

Study Countries:

Gambia, Ghana, Multi-Countries

Study Design:

Case-Control Study, Cohort Study, Cross Sectional Study, Grounded Theory, randomised-control-trial

Study Approach:

Qualitative

Participants Gender:

Female

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