Protocols

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    Acceptability of new Orange Fleshed Sweet Potato varieties among children and caregivers in Nsanje, Malawi, version 1.0
    (Kamuzu University of Health Sciences, 2022-08-04) Manda, Robert
    Type of Study: A cross-sectional study will be conducted in Nsanje among children and their caregivers to determine their sensory acceptability and consumer preference for new orange fleshed sweet potato (OFSP) varieties bred in Malawi. Problem Statement: OFSP are some of the bio-fortified crops bred in Malawi. However, bio-fortification results into different visual phenotypes and taste changes than pre-existing varieties of the crops. Due to these changes, sensory attributes are also affected and acceptability of these newly introduced varieties is a challenge. Main Objective: To assess consumer preference and sensory acceptability of new biofortified orange fleshed sweet potato varieties bred in Malawi by International Potato Centre (CIP) among children aged 12-59 months and their caregivers in Nsanje Malawi. Specific Objectives: i) To assess sensory acceptability of new OFSP varieties among children aged 12-59 months. ii) To determine consumer preference for new OFSP varieties among caregivers of children aged 12-59 months. iii) To assess sensory acceptability of new OFSP varieties among caregivers of children aged 12–59 months. Methodology: New OFSP varieties that will be assessed in this study are Anaakwanire, Kaphulira, Mathuthu, Royal Choice, Mthetsanjala and Msungabanja. These varieties will be assessed against local sweet potato varieties grown in Malawi. Plate waste and hedonic Likert scale sensory techniques will be used to assess acceptability of the sweet potatoes among children aged 12-59 years. Paired preference test and preference ranking sensory procedures will be used to assess consumer preference for the sweet potatoes among caregivers of children aged 12–59 months. Pearson correlation co-efficient will be used to measure likeness, preference and levels of satisfaction of the sweet potatoes among children and caregivers. Expected results: The study expects to find acceptability of new OFSP among children and caregivers to reduce Vitamin A Deficiency which is a public health concern in Malawi and drivers of consumers preference for new OFSP varieties. Dissemination: The findings will be disseminated through conference presentation to KUHEs-COM, CIP, UNICEF, DNHA, The Hunger Project, Nsanje District Council, others nutritional stakeholders and journal publication for utilization. For academic purpose, a copy of the dissertation will be sent to Kamuzu University of Health Sciences, COMREC and KUHES libraries for reference.
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    Analysis of beta-carotene from Malawians grown carrots for pharmaceuticals and food colourings
    (Kamuzu University of Health Sciences, 2021-03-04) Fundi, Beatrice; Milanzi, Alinafe
    Type of study/Place of study: The research design is an experimental method and will be conducted at the Pharmacy laboratories. Background and Introduction: Carrot is one of the important root vegetables. It has a long history of use by Malawians, traditionally being used in salad. However, carrot has medicinal properties, particularly as antioxidant and anticancer due to presence of carotenoids most commonly β-carotene. The use of β-carotene from carrots in food and pharmaceutical products increase intake of micronutrients which are essential for body processes. In Malawi up to date no research has been conducted to analyze β-carotene from the Malawian grown carrots for pharmaceuticals and food colorings. Study Objectives: The main aim of this work is to investigate the physicochemical properties of β-carotene from Malawian grown carrots for application in food and pharmaceutical products. The specific objectives of this study include; to establish the β-carotene levels from carrots grown under different ecological zones, to determine the stability of β-carotene extracted from carrots obtained from different sources and to determine the solubility of β- carotene in oil-water (o/w) interfacial solvent system. Methodology: Carrots will be collected from the garden at Bvumbwe and Sangano in Thyolo and Ntcheu districts respectively. This is because these districts have different climatic conditions and soil type which might affect levels of β-carotene. Carrots will be randomly collected and kept at room temperature and the analysis will be done at COM Pharmacy laboratory. The carrot roots will be grinded or crushed and the extract where the β-carotene will be produced is extracted using suitable solvents. Solvents will be used for the extraction and the extracts will be tested for the presence and concentration of β-carotene using a standard method outlined in methodology. Data Management and Dissemination: All the data collected will be presented and recorded in Microsoft Excel 2016and statistical analysis will be done using Epi info. It is expected that the results will positive. The results of this study will be disseminated to the following bodies COMREC, Pharmacy department, Undergraduate research project coordinators and COM library
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    Assessing breastfeeding and complimentary feeding practices during COVID-19.
    (Kamuzu University of Health Sciences, 21-08-11) Phuka, John
    Study type: Mixed methods cross-sectional study Problem: The corona virus disease (COVID-19) has had severe consequences on the social aspects of human interaction. Particularly, measures aimed at deterring the spread of disease such as social distancing and wearing of masks have likely hindered infant and young child feeding and care practices including breast feeding, child and mother interaction as well as family or community participatory support. Breast feeding is essential for children’s optimal physical and cognitive growth, especially in settings highly burdened with malnutrition. Monitoring of breastfeeding and complementary feeding practices during the pandemic is critical to ensure that women can continue to breastfeed their children safely and mitigate the risks of malnutrition. However, care practices of infants and children in the context of pandemic have not been well studied. Therefore, this study aims to pilot our modified questionnaire on breastfeeding knowledge and practices as well as obtain essential data on infant and young child feeding practices Methodology: The study will recruit 415 participants from Nkhata Bay and Lilongwe. Enumeration areas will be randomly selected from each district, thereafter households with children aged 0-24 months will be identified through community leaders and health surveillance officers. Data will be collected from mothers or care givers of children through a structured questionnaire and focus group discussions. Expected results and dissemination: Study outcomes may inform national nutrition programming, the global maternal nutrition reports and other key advocacy reports on exclusive breast feeding and complementary feeding practices during the pandemic. The findings of this research will be presented to United National Children’s Emergency Fund (UNICEF), DNHA, Ministry of Health and relevant stakeholders. A completed final report of the study will be submitted to UNICEF, DNHA, COMREC and MoH.
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    Assessment of antibiotic resistance in humans and in food animals in Blantyre in Malawi
    (Kamuzu University of Health Sciences, 2022-05-12) Mbamira, Simeonoe
    Studytype:thisisadescriptiveandretrospectivestudy.Problem:antibiotic resistanceisagrowingpublichealththreatofamajorconcerntocountriesand multiplesectors.Thisthreatensone-healththatisbothpublichealthandveterinary. Dataisavailableonantibioticresistanceinhumans.However,dataonthetrendof thisantibioticresistanceinbothhumanandveterinarymedicineisscantyhencethis study.Objectives:toassessantibioticresistanceinhumansandinfoodanimals (cattle,goats,pigs,chickens)inBlantyre,Malawi.Methodology:qualitativedata collectionmethodwillbeemployed.Datawillbecollectedfromtherecordson antibioticresistanceforthepast6yearsthatisfrom2021downto2015fromQECH andBlantyreveterinaryandthisdatawillbeanalyzed.Expectedresults:itis expectedthattherewillbeanincreasingtrendofantibioticresistanceinbothhuman medicineandfoodanimals.Disseminationofresults:theresultswillbe disseminatedthroughconductionofpresentationsandthroughattendanceoflocal conferences.AcopyofthefinalreportwillbesenttoQECH,Blantyreveterinary, CollegeofMedicineResearchEthicsCommitteeandothers.
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    Determinants of non-compliance to iron and folic acid supplementation among adolescent girls in schools of Salima district
    (Kamuzu University of Health Sciences, 2022-09-09) Mhango, Memory
    Executive Summary Type of the study This will be a school-based quantitative cross-sectional study aiming at assessing the determinants of non-compliance to iron and folic acid supplementation among adolescent girls in selected schools in Salima district. Problem In Malawi, the prevalence of anaemia among adolescent girls is unacceptably high. The Malawi demographic health survey (MDHS) 2015-2016 indicated the anaemia prevalence of 35.3% among adolescent girls. World health organization (WHO) recommends iron and folic acid supplementation to adolescent girls in a country with prevalence of more than 20%. The recommendation is based on evidence that Iron and Folic Acid Supplementation (IFAS) has been proved cost effective way of improving iron status especially in developing countries. Considering this, the ministry of health, in collaboration with the ministry of education and other partners in 2019 launched the weekly IFAS program for adolescent girls aged 10 to 19 years to mitigate the 35.3% prevalence of anemia among adolescent girls in the country. The program was piloted in six districts of Mangochi, Dedza, Salima Lilongwe, Dowa, and Machinga, and later rolled out to other districts. However, since the implementation started in Salima district, compliance rates have been disappointingly low below the national requirement of 100% for the past 3 years of implementation. According to Salima Health Information and Management System (HMIS) data for school platform, from July to December 2019, the program had a coverage of 79% with a compliance rate of 61%. In 2020, the same duration, 69% IFAS coverage was achieved with a compliance rate of 14%, and from July to December 2021, 82% IFAS coverage was achieved with a 21% compliance rate. Yet, the reasons behind the low compliance remain unknown due to limited literature and being a new intervention among adolescent girls in Malawi. Hence the need for this study. Broad Objective The aim of the study is to assess determinants of non-compliance to Iron and Folic Acid supplementation among adolescent girls enrolled in selected schools in Salima district. Specific Objectives (1) To determine the adolescent girls‘ level of knowledge of Iron deficiency anaemia and IFAS program in selected schools in Salima district. (2) To identify individual factors affecting compliance with IFAS among adolescent girls enrolled in selected schools in Salima district. (3) To examine modifying factors affecting compliance to IFAS among adolescent girls enrolled in selected schools in Salima district. Methodology The study will be conducted in randomly selected primary schools and is targeting adolescent girls (10 to 19 years) with a sample size of 106 calculated using Cochran's formula. Sampling will be done in stages (multi stage sampling) to select the health facilities, schools, and adolescent girls (responded). The data will be collected through face to face interviews using a structured questionnaire and analyzed using SPSS version 22. Descriptive statistics will be used to present the data in figures and tables. And then, logistic regression analysis will be carried out to identify determinants of IFAS non-compliance. The ethical approval to conduct this study will be sort from college of medicine research and ethics committee (COMREC) and institution clearance was obtained from Salima district council, education department. Expected findings The study findings will document determinants of non-compliance to IFAS among adolescent girls. This will give evidence that will serve as a basis for recommendation to policymakers, program managers, advocators and service providers to formulate policies and improve IFAS program strategies by including interventions that will promote compliance among the girls hence reducing the prevalence of iron deficiency anemia. Dissemination of the results The findings will be presented to schools and district nutrition coordinating committee (DNCC) in Salima, COMREC, and ministry of health, department of nutrition and HIV Aids (DNHA). The study findings will be published in a reputable peer review journals and presentedat a conference. A copy of thesis will be in Kamuzu University of health sciences (KUHES) library.
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    Determinants of Under-5 Malnutrition in Dedza District, Malawi
    (2022-07-13) Kulemero, Flera
    Type of Study This study will use a quantitative approach to analyze the determinants of under-5 malnutrition in Dedza district, Malawi using the Malawi Demographic and Health Survey (MDHS) 2015 – 16 data. Problem Statement Dedza district in Malawi is among the districts with high rates of under-5 malnutrition as per the MDHS of 2015 – 16. This is worrisome considering that Dedza is among the districts that is known to produce a variety of crops for consumption and commercial purposes. There is need, therefore, to understand district specific determinants of malnutrition in children 5 years and below. This will pave way for public health interventions to reduce childhood malnutrition rates in the district. Objectives Broad Objectives The aim of this study is to describe the distribution, household and parental socio-demographic characteristics, vaccine status in under-5 children and their association with malnutrition in children 5 years and below in Dedza district, Malawi. Specific Objectives • To determine household and parental socio-demographic characteristics and their association with malnutrition in Under-5 children in Dedza district, Malawi • To determine the distribution of malnutrition among Under-5 children that are fully vaccinated, partially vaccinated, and unvaccinated in Dedza district, Malawi. Methodology This will be a cross-sectional quantitative study that will analyze secondary MDHS 15 - 16 data to assess the determinants of under-5 malnutrition in Dedza district. Expected Findings and Dissemination of the Results This study is expected to find the distribution of under-5 malnutrition in the district. In addition, it is likely to show the relationship of maternal and household characteristics and their influence on under-5 malnutrition in Dedza. A close-up report of the study and the findings will be shared with13-Jul-2022 xiv Determinants of Under-5 Malnutrition in Dedza, Malawi; Version 3 – June, 2022 COMREC and thereafter, a written report of the findings of this study will be shared with the DHSS in Dedza. Furthermore, a manuscript will be published in peer reviewed journal and other copies distributed to the KUHeS library, the DHS program and to PACHA
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    Enhancing pathways from agriculture-to-nutrition
    (Kamuzu University of Health Sciences, 2021-12-03) Kalumikiza, Zione
    Study TitleType of research study: Women’s empowerment in nutrition and maternal nutrition outcomes: examination of linkages and identification of strategies for optimising outcomes among beneficiaries of a feeding trial in a rural agro-based community in Malawi The proposed study is a cross-survey that determines associations between Women’s empowerment and maternal nutrition outcomes in a rural Malawian community. Consensus exists that addressing malnutrition, a problem of public health significance in Malawi, will require a combination of both nutrition specific and sensitive interventions. Women’s empowerment, alone, or through the agriculture impact pathway, has generated considerable interest within various sectors, nutrition inclusive, despite limited evidence of its impacts on nutrition. The proposed study to be conducted in Kasungu District under Wimbe Traditional Authority, involves research to this effect. Problem: The nature, strength, and direction of associations between women’s empowerment and nutrition outcomes seems to vary widely and is ambiguous. No local research has assessed comprehensively associations between women’s empowerment and maternal nutrition or attempted to measure women’s empowerment in the realm of nutrition. Using a measure closely related to nutrition, the proposed study will provide data on the status of women’s empowerment and propose actions to facilitate nutrition empowerment and outcomes. This ambiguity largely stems from differences in the measures used for women’s empowerment. This is further compounded by a lack of local data in the field to inform actions. No research in Malawi has attempted to measure women’s empowerment in the realm of nutrition or assessed comprehensively associations between women’s empowerment and maternal nutrition. This study, therefore, will not only add to the body of knowledge in the relevant fields, but will generate evidence with policy and programmatic implications. proposes research which can support and guide national strategies and policies in these dimensions. Objectives: Broadly, the study seeks to identify strategies for optimising maternal nutrition outcomesdetermine the status of nutritional empowerment among women of reproductive age in a rural Malawian community using a novel index, the Women’s Empowerment in Nutrition Index (WENI) and assess its associations with nutrition outcomes. Specific study objectives are; (i) to determine the level and extent to whichstatus of nutritional women are empowered in nutrition using a novel index,empowerment in the study population the Women’s Empowerment in Nutrition Index (WENI); (ii) to measure determine associations between the WENI and the Body Mass Index (BMI), Mid Upper Arm Circumference, and, dietary diversity of women in the study area; (iii) to examine assess the effect of provision of a staple food (maize flour) on dietary diversity, and intakes of energy, protein, iron and folate; and, (iv) to examine assess changes in dietary quality (diversity) among the WRA 2 years after participation in a feeding trial. Methodology: The study combines a cross sectional survey designed to collect and measure status of women’s empowerment in nutrition and its associations with maternal nutrition outcomes, and, secondary analysis of data from an intervention study, the “Alleviating Hidden Hunger with Agronomy (AHHA)” conducted within the Geo Nutrition project (reference: P.05/18/2393). The analysis of the AHHA data will measure changes in diversity and intakes of energy, protein, iron, and folate following receipt of a staple food (maize flour). The changes in diversity over time will also be assessed to see to what extent benefits, if any, are sustained over time. For the WENI survey, face-to-face interviews will be conducted with women who participated in the AHHA study (n=180), guided by a semi-structured interviewer administered questionnaire. Microsoft Excel, IBM SPSS Statistics version 25, will be used in the data entry and analyses phase respectively. In addition to general descriptive statistics, Fischer’s LSD test and the Dunnett’s test will be used to examine assess changes in nutrient intakes. To test for associations between women’s empowerment in nutrition and nutrition outcomes, chi-square analyses will be used. Multivariate logistic regression will be employed to identify specific empowerment domains closely related to nutrition outcomes. This study is part of a Doctoral Research for Ms Zione Kalumikiza. Expected Findings and Dissemination. The study is expected to measure the level of women’s empowerment in nutrition and identify areas of disempowerment, which provides a basis for the type of interventions needed to improve nutrition and health of women in similar contexts. By investigating associations between women’s empowerment in nutrition and maternal nutrition outcomes, the study helps to understand the extent to which the empowerment index (WENI) can be used as a predictor of nutritional status hence its application in both nutrition programming and assessments. Variations are expected in empowerment across the different domains with most participants demonstrating empowerment in the knowledge domain as opposed to resources and control domains. This is largely because women are the main targets for nutrition education and are less often provided with resource support or linkages to institutions. In addition, rural communities often favour males on control of resources. Overall, this study will identify specific areas of disempowerment and provide a basis for the type of interventions needed to improve nutrition and health of women in similar contexts. It will further help to understand the extent to which the empowerment index (WENI) can be used as a predictor of nutritional status hence its application in both nutrition programming and assessments. We further test the influence of empowerment in a single domain-dimension (food/maize flour provision) and hope this generates evidence for informing the design of similar nutrition-sensitive interventions for better impact. Finally, the study will explore whether dietary changes resulting from the AHHA intervention are sustained over time. Taken together, this study will identify barriers to nutrition empowerment and thus propose actions to facilitate nutrition empowerment and outcomes. The study, therefore, will not only add to the body of knowledge about nutrition and empowerment, but generate evidence with policy and programmatic implications. Study findings will be presented to the scientific community through publications in peer reviewed journals and presentations at national and international conferences. The Kasungu local council and concerned Traditional Authority will also be presented with key findings from this research. A copy of the thesis and all published work from this study will be shared with the College of Medicine Library, the College of Medicine Research Ethics Committee, and other relevant committees in line with requirements by the College of Medicine.
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    Enhancing pathways from agriculture-to-nutrition: a study of women’s empowerment in nutrition, nutrition outcomes, and, strategies for optimising nutrition among beneficiaries of a feeding trial in rural Malawi
    (Kamuzu University of Health Sciences, 3-12-21) Kalumikiza, Zione
    The proposed study is a cross-survey that determines associations between Women’s empowerment and maternal nutrition outcomes in a rural Malawian community. Problem: The nature, strength, and direction of associations between women’s empowerment and nutrition outcomes seems to vary widely and is ambiguous. No local research has assessed comprehensively associations between women’s empowerment and maternal nutrition or attempted to measure women’s empowerment in the realm of nutrition. Using a measure closely related to nutrition, the proposed study will provide data on the status of women’s empowerment and propose actions to facilitate nutrition empowerment and outcomes. This study, therefore, will not only add to the body of knowledge in the relevant fields, but will generate evidence with policy and programmatic implications. Objectives: Broadly, the study seeks to determine the status of nutritional empowerment among women of reproductive age in a rural Malawian community using a novel index, the Women’s Empowerment in Nutrition Index (WENI) and to assess its associations with nutrition outcomes. Specific study objectives are; (i) to determine the to etermine associations between the WENI and the Body Mass Index (BMI), Mid Upper Arm Circumference, and, dietary diversity of women in the study area; (iii) to assess the effect of provision of a staple food (maize flour) on dietary diversity, and intakes of energy, protein, iron and folate; and, (iv) to assess changes in dietary quality (diversity) among the WRA 2 years after participation in a feeding trial. Methodology: The study combines a cross sectional survey designed to collect and measure status of women’s empowerment in nutrition and its associations with maternal nutrition outcomes, and, secondary analysis of data from an intervention study, the “Alleviating Hidden Hunger with Agronomy (AHHA)” conducted within the Geo Nutrition project (reference: P.05/18/2393). The analysis of the AHHA data will measure changes in diversity and intakes of energy, protein, iron, and folate following receipt of a staple food (maize flour). The changes in diversity over time will also be assessed to see to what extent benefits, if any, are sustained over time. For the WENI survey, face-to-face interviews will be conducted with women who participated in the AHHA study (n=180), guided by a semi-structured interviewer administered questionnaire. Microsoft Excel, IBM SPSS Statistics version 25, will be used in the data entry and analyses phase respectively. In addition to general descriptive statistics, Fischer’s LSD test and the Dunnett’s test will be used to assess changes in nutrient intakes. To test for associations between women’s empowerment in nutrition and nutrition outcomes, chi-square analyses will be used. Multivariate logistic regression will be employed to identify specific empowerment domains closely related to nutrition outcomes.
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    Factors associated with adherence to feeding protocols in stabilization phase of severe acute malnutrition management: Kamuzu Central Hospital, Lilongwe
    (2021-11-11) Gaven, Wilfred
    A retrospective cohort study design utilizing quantitative method will be conducted. During the process, every fourth case file of 6 to 59 months old SAM children admitted in four years from 2017 to 2021 will be selected till 459 sample size is reached. Later those selected files will be reviewed. Severe acute malnutrition remains a global challenge affecting 16.6 million out of 238 million under-five malnourished children and thus representing 7% with a death rate of 5% annually. Most of SAM cases are highly prevalent in Asia, Sub-Saharan Africa and Haiti in Latin America because the nation was hit by cholera epidemics which led to economic collapse. Asia has 12 million SAM children and thus representing a larger morbidity and mortality rate compared to other regions. Malawi through the study done at Kamuzu Central Hospital showed 9.7% of 6 to 36 months old SAM children with a death rate of 10.1%. Despite Malawi having done a lot to review community-based management of acute malnutrition guidelines and training of health workers on the same, there are still increased deaths in children with SAM. Again, there is inadequate data on adherence to SAM treatment, hence the need to do the study. The study aims at assessing factors associated with level of adherence to feeding protocols of severely malnourished under-five years of age children at KCH. The specific objectives will be: to determine adherence level to feeding protocols in the stabilization phase, to establish association between shift times and adherence, to expose association between days of the week and adherence, to establish association between wards of admission and adherence and determine association between outcome and adherence. A retrospective cohort design will be used to review all 6 to 59 months SAM children case files from 2017 to 2021. KCH, a tertiary referral hospital in Lilongwe, the Capital of Malawi which serves patients from nine district hospitals in the Central Region, will be used. The pediatric ward will be the exact place to do the study. A systematic sampling will be done where every fourth [1740/459] case file will be selected till the sample size is reached. Data collection will be done by using data extraction sheet which has six sections A, B, C, D, E and F. The form has both dependent variables to define adherence and independent variables against which adherence will be quantified. Descriptive statistics will be used for socio-demographic and clinical characteristics of the patients. The level of adherence to feeding protocol will be calculated by using the measures of relative frequency. Univariable and multivariable logistic regression analysis will be used to assess the association between adherence and each independent variable. Association between prognosis and adherence level will be established by Chi-square/Fisher’s Exact test to find the proportion. Data will be presented in graphs, tables, stem and leaf formats. Expected findings will include: proportion of adherence level, the differences in association between levels of adherence and independent variables and the level of association between prognosis and adherence level. Dissemination will be through morning reports, conference presentation and journal publication. A copy of the dissertation will be sent to Kamuzu University of Health Sciences, COMREC, KCH and Malawi College of Health Sciences libraries for reference.
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    Factors associated with adherence to feeding protocols in stabilization phase of severe acute malnutrition management: Kamuzu Central Hospital, Lilongwe
    (Kamuzu University of Health Sciences, 2021-11-11) Gaven, Wilfred
    A retrospective cohort study design utilizing quantitative method will be conducted. During the process, every fourth case file of 6 to 59 months old SAM children admitted in four years from 2017 to 2021 will be selected till 459 sample size is reached. Later those selected files will be reviewed. Severe acute malnutrition remains a global challenge affecting 16.6 million out of 238 million under-five malnourished children and thus representing 7% with a death rate of 5% annually. Most of SAM cases are highly prevalent in Asia, Sub-Saharan Africa and Haiti in Latin America because the nation was hit by cholera epidemics which led to economic collapse. Asia has 12 million SAM children and thus representing a larger morbidity and mortality rate compared to other regions. Malawi through the study done at Kamuzu Central Hospital showed 9.7% of 6 to 36 months old SAM children with a death rate of 10.1%. Despite Malawi having done a lot to review community-based management of acute malnutrition guidelines and training of health workers on the same, there are still increased deaths in children with SAM. Again, there is inadequate data on adherence to SAM treatment, hence the need to do the study. The study aims at assessing factors associated with level of adherence to feeding protocols of severely malnourished under-five years of age children at KCH. The specific objectives will be: to determine adherence level to feeding protocols in the stabilization phase, to establish association between shift times and adherence, to expose association between days of the week and adherence, to establish association between wards of admission and adherence and determine association between outcome and adherence. A retrospective cohort design will be used to review all 6 to 59 months SAM children case files from 2017 to 2021. KCH, a tertiary referral hospital in Lilongwe, the Capital of Malawi which serves patients from nine district hospitals in the Central Region, will be used. The pediatric ward will be the exact place to do the study. A systematic sampling will be done where every fourth [1740/459] case file will be selected till the sample size is reached. Data collection will be done by using data extraction sheet which has six sections A, B, C, D, E and F. The form has both dependent variables to define adherence and independent variables against which adherence will be quantified. Descriptive statistics will be used for socio-demographic and clinical characteristics of the patients. The level of adherence to feeding protocol will be calculated by using the measures of relative frequency. Univariable and multivariable logistic regression analysis will be used to assess the association between adherence and each independent variable. Association between prognosis and adherence level will be established by Chi-square/Fisher’s Exact test to find the proportion. Data will be presented in graphs, tables, stem and leaf formats. Expected findings will include: proportion of adherence level, the differences in association between levels of adherence and independent variables and the level of association between prognosis and adherence level. Dissemination will be through morning reports, conference presentation and journal publication. A copy of the dissertation will be sent to Kamuzu University of Health Sciences, COMREC, KCH and Malawi College of Health Sciences libraries for reference.
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    Factors associated with treatment outcomes of severe acute malnutrition among under-five children admitted at Queen Elizabeth Central Hospital (QECH) nutrition unit. A retrospective cross-sectional study
    (Kamuzu University of Health Sciences, 2021-12-10) Ndhlovu, Mirriam
    Type of the study: A retrospective cross-sectional study. Problem to be studied: Malnutrition is a physiological condition that results from energy, protein and other nutrient deficiencies leading to growth impairment or excess intake of nutrients causing obesity. There are immediate, underlying and basic causes of malnutrition. Under-nutrition may be caused by diseases and or inadequate intake of macronutrients/micronutrients. Severe acute malnutrition is defined as weight for height/ length of <-3z score or MUAC<11.5cm or bilateral pitting oedema of +2 to +3 in children aged 6 to 59 months. Children with severe acute malnutrition are more susceptible to diseases which increases their mortality. Much of the research in severe acute malnutrition has focused on treatment options to improve treatment outcomes. However, mortality estimates in severe acute malnutrition have remained high in Malawi despite government’s effort to reduce child mortality. Objectives of the study are: Broad objective • To assess factors associated with treatment outcomes of severe acute malnutrition among children aged 1 month to 59 months admitted for nutrition feeding at Queen Elizabeth Central Hospital (QECH). Specific objectives I. To determine whether the admission category (new / readmission) is associated with treatment outcomes of severe acute malnutrition among children aged 1 to 59 months admitted at QECH nutrition unit. II. To determine whether the presence of a particular medical comorbidity (pneumonia, anaemia, TB, diarrhoea, malaria, sepsis and neural disability such as cerebral palsy) is associated with treatment outcomes of severe acute malnutrition among children aged 1 month to 59 months admitted at QECH nutrition unit. III. To determine whether socio-demographic characteristics (age, sex, and primary care taker) of the children aged 1 month to 59 months admitted at QECH nutrition unit are associated with treatment outcomes of severe acute malnutrition. Methodology: This will be a retrospective cross-sectional study to be conducted at QECH nutrition unit from July 1, 2017 to July 31, 2020. The study population will be all malnourished children aged 1 month to 59 months admitted at QECH nutrition unit. All children with surgical and orthopedic conditions will be excluded from the study. A sample size of 312 will be used for the study to achieve 90% power at 5% significance level. Data will be extracted from inpatient registration book and patient medical records. The study population will be divided into two strata, namely; recovered and not recovered. Proportionate will be calculated for each stratum based on total number of study population. The desired sample size will be multiplied by the proportion of units in each stratum. Finally, systematic random sampling will be used where every kth unit will be selected from each stratum. Expected findings and dissemination: Recovery rates and death rates of SAM children aged 1 month to 59 months will be established. Factors associated with the outcomes will be identified and association described. Results of this study will be shared with Kamuzu University of Health Sciences (KUHeS), COMREC, and QECH. Dissemination of the results will also be done in conferences and peer reviewed publications.
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    Health care workers’ nutritional care practices in Paediatric Oncology Units at Kamuzu and Queen Elizabeth Central Hospitals
    (Kamuzu University of Health Sciences, 2021-02-10) Sabantini, Memory Tiwonge
    Type of study: This is a cross sectional study Study problem: Malnutrition, particularly undernutrition is a poor prognostic factor in children with cancer. Over 50% of children admitted in Paediatric oncology units in Malawi are malnourished and just like in many low and middle income countries(LMIC) where malnutrition in childhood cancer is also significant, survival rate is low. An already high prevalence of primary malnutrition has shown to exacerbate malnutrition in cancer in LMIC. Studies conducted across the Globe have demonstrated that proper nutritional interventions improve a child’s nutritional status and promotes survival in childhood cancer and that calls for a proper nutritional management plan which most oncology units, especially in the western world are striving to achieve. In Malawi however, there are no guidelines that specifically look at the management of malnutrition in cancer children and the current nutritional care practices remain unclear. Broad Objective: To evaluate health care workers’(HCW) nutritional care practices in paediatric oncology units at Kamuzu and Queen Elizabeth Central Hospitals. Specific Objectives i. To examine the criteria, screening tools and assessments that HCW employ to identify malnourished children at KCH and QECH Paediatric oncology units. ii. To assess the nutritional support and treatment interventions that HCW provide to malnourished children at KCH and QECH Paediatric oncology units. iii. To assess the discharge criteria and follow up care of malnourished children at QECH and KCH Paediatric oncology units. iv. To explore HCW’s perceived barriers and facilitators to providing nutritional care interventions to malnourished children at KCH and QECH Paediatric oncology units Methodology: This is a qualitative study in which in-depth interviews will be conducted among health care workers (Nurses, clinicians and Doctors) working in the pediatric oncology units at both Kamuzu and Queen Elizabeth central hospitals using a semi-structured interview guide. Purposive sampling will be used to select 30 most experienced health personnel in the units and the interviews will be audiotaped. The collected data will then be transcribed, coded and themes will be generated. The collected data shall also be stored in a secure location. Constraints: Participating in an interview that lasts more than 30 minutes may be deemed as time consuming and other health care workers may feel the need to rather attend to patients than spend time being interviewed. Others may also feel the need to not be truthful so as to portray a good picture of best practices on themselves which would affect the results of the study Expected findings: This study expects to find inconsistencies in the provision of nutritional care among individual health care workers as well as between the two facilities and also non-adherence to the current National nutritional guidelines. Dissemination of results: Copies of this study will be shared with both study sites as well as COMREC. The results of this study shall be disseminated through VIVA at College of Medicine and will also be presented at one KCH Paediatric Oncology Wednesday meetings, Global Hope Nursing Echo seminars as well as at International Society of Paediatric Oncology (SIOP) 2022 conference. In addition, these findings are also intended to be published in a journal article.
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    Identification of malnutrition in infants using ultrasound – a proof-ofconcept
    (Kamuzu University of Health Sciences, 2022-09-01) Iroh Tam, Pui-Ying
    Study Type: Cross-sectional case-control: The problem: Early identification of at-risk infants for severe malnutrition (SM) has been highlighted as a top research priority. However, few easy and reliable diagnostics are available and predictive for infants and children. Current anthropometric measures (such as weight-forlength/ height z scores, WLZ), have <50% sensitivity for predicting mortality, and poor correlation with mid-upper arm circumference (MUAC). Other, more sensitive measures of growth and nutritional status may be body composition (fat mass and fat-free mass), thymus gland, and other organs, however current approaches are time- and labour-intensive and require specialized equipment such as CT, MRI or air displacement plethysmography. A noninvasive test that can measure correlates of nutrition and be done at the bedside, such as a ultrasound, may, if shown to be sensitive and a good predictor of morbidity and mortality, support screening for therapeutic feeding programmes in low resource settings. Broad objective: To assess utility of ultrasound in identification of malnutrition. Specific objectives: 1. To document feasibility of conducting ultrasound measurements in infants. 2. To determine inter-user reliability and reproducibility in ultrasound measurements. 3. To evaluate whether there are differences in measurements between malnourished v. nonmalnourished infants. Place of study: Queen Elizabeth Central Hospital, Paediatric wards. Study population: Children <6 months of age. Study methods: • 10 infants <6 months hospitalized with malnutrition will be age- and sex-matched with 10 non-malnourished hospitalized children. • For each enrolled infant, sociodemographic data (clinical diagnosis, birthweight), anthropometry (weight, length, MUAC) and ultrasound measurements (biceps, quadriceps, rectus abdominis, thymus, etc) will be collected, measured and documented. Expected findings and their dissemination: We expect that ultrasound measurements in infants will be feasible, and have reasonable inter-user reliability and reproducibility between examiners. We expect to identify differences in measurements between infants with and without malnutrition. Study findings will be presented to MLW, QECH, and COMREC Research Dissemination Conference, and may be published in a peer-reviewed journal.
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    Pancreatic enzymes and bile acids: A non-antibiotic approach to treat intestinal dysbiosis in acutely ill severely malnourished children
    (Kamuzu University of Health Sciences, 20-09-08) Bandsma, Robert
    Background (Problem to be studied) Severely malnourished children who present with an acute illness have a high risk of mortality. Severe malnutrition is associated with intestinal inflammation and changes in the faecal microbiome (‘dysbiosis’). Apart from the large intestine, this dysbiosis is also present in the small intestine, where increased bacterial density and altered microbial composition can contribute to intestinal inflammation and intestinal dysfunction which may ultimately contribute to the development of sepsis and death. The bacterial density and composition in the small intestine can be reduced and altered, respectively, using antibiotics. However, apart from side effects, antibiotic use contributes to the development of antibiotic resistance, which is very common in hospitalized malnourished patients and can pose a threat to both individual and public health. In addition to intestinal dysbiosis and intestinal inflammation, children with severe malnutrition suffer from impaired exocrine pancreatic and hepatobiliary function, which are important for nutrient digestion and absorption. We recently reported that treating children with severe malnutrition with pancreatic enzymes led to a reduction in mortality in a pilot trial 08-Sep-2020 CONFIDENTIAL PB-SAM Version 1.2 Dated 1 September-2020 Page 6 of 440 which was not powered for mortality. Importantly, enzymes and bile acids produced by the pancreas and liver affect bacteria that reside in the intestinal lumen. We hypothesize that providing these enzymes exogenously to severely malnourished children will improve their clinical outcome by reducing dysbiosis, intestinal inflammation and sepsis. Objective The objective of this study is to determine whether treating ill severely malnourished children with pancreatic enzymes or bile acids improves mortality. Methodology We will conduct a double blind, randomized clinical trial in a 2x2 factorial design in hospitalized severely malnourished children. We will treat participants with paediatric formulations of pancreatic enzymes, bile acids, both or placebo(standard antibiotic therapy for SAM inpatient treatment) for 21 days. Participants will be followed up daily during their hospital stay and on day 21 and 60 after enrolment. We will conduct this trial in three stages to allow for careful interim evaluations to assess safety and study progress. In the first and second stage, we will conduct interim analyses to assess safety and likelihood of benefit before enrolling the full sample size to assess mortality as the primary outcome. Secondary outcomes include adverse events, length of hospital stay and growth. Exploratory outcomes will examine intestinal and systemic inflammation and metabolic changes to examine mechanisms affected by the interventions, and costs. Two sub-studies will be conducted. In Kenya and Bangladesh, daily blood gases, lactate and biochemistry for the first 5 days to assess early clinical progress. In Malawi and Uganda, hydrogen breath testing will be used to evaluate impact on upper small intestinal bacterial overgrowth. Overall, this trial will determine whether a non-antibiotic, bactericidal intervention given in additional to standard of care management reduces mortality in acutely ill severely malnourished children. Expected findings We expect mortality, deterioration, and readmission to be lower amongst children admitted to hospital and treated for complicated SAM by administration of pancreatic enzymes or bile acids compared to placebo. Dissemination 08-Sep-2020 CONFIDENTIAL PB-SAM Version 1.2 Dated 1 September-2020 Page 7 of 440 The findings of the study will be published in peer reviewed journal and will also be shared College of Medicine Ethics and Research Committee (COMREC), hospitals and the study community in all participating countries.
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    Randomized, single-blinded, prospective clinical trials comparing the impact of legumes vs corn-soy flour on environmental enteric dysfunction and stunting in rural Malawian children 12-23 months old
    (2022-04-26) Manary, Mark; Maleta, Kenneth
    Executive Summary: Type of study: Randomized, investigator-blinded, prospective clinical trial Problem to be studied: Environmental enteric dysfunction (EED) and stunting in children Objective: Evaluate the effectiveness of two different legume foods (cowpeas and common beans) in maintaining and/or restoring normal gut absorptive and immunological function in rural Malawian children at high risk for EED and stunting during their second to third years of life. Methodology: A prospective randomized, investigator-blinded prospective clinical trials will be used to evaluate whether supplementary feeding with cowpeas or common beans improves biomarkers of EED, growth parameters, and the health of the intestinal microbiome. 300 healthy children aged 12-23 months will be equally randomized to receive a legume-based complementary food made from cowpeas (first intervention group), common beans (second intervention group), or an isoenergentic amount of corn flour with 10% soy (control group), a traditional Malawian complementary food. The energy content of the complementary foods provided will be in accordancewith WHO specifications [1], approximately 15% of the estimated total daily intake. Before the complementary foods are given, the children will participate in a dual sugar permeability test at a designated village healthcare center and give stool samples for additional biomarker tests to measure gut function and also to evaluate the evolution of the enteric microbiome while receiving the assigned complementary food. The dual sugar permeability test (the lactulose-rhamnose test) involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter. Dietary intake will be assessed every 6 weeks. Children will return 12, 24, 36, and 48 weeks after starting the intervention for postintervention assessments, including the dual sugar absorption test, stool collection, and anthropometric measurements. Primary outcomes for the study will be: 1) a standard marker of EED, specifically changes in the urinary lactulose:rhamnose ratio (L:R) during the course of the interventions; 2) a standard marker of growth, the change in height-for-age Z-score. The secondary outcomes will include the amounts of lactulose and rhamnose excreted in the urine as a percentage of the amount ingested before and after the intervention. Additional secondary outcomes will be adverse gastrointestinal symptoms, as well as changes in the enteric microbiome, stool biomarkers of EED: IL-8, IL-17A, CD-3, Reg 1A, calprotectin, and zonulin, and investigation of potential novel biomarkers of EED through host transcriptomic analysis of stool samples. Expected findings and their dissemination: It is expected that children receiving the legume-based complementary foods will have improvements in their dual sugar permeability testing and immunoinflammation biomarkers in comparison with the group receiving standard corn-soy flour, indicating that their EED has improved. Results will be shared with participants and the sponsoring institutions, as well as submitted for publication in a peer-reviewed journal. The purpose of re-submitting this protocol is to allow for continued storage as well as application of an improved methodology for an original secondary objective, investigation of stool biomarkers of EED by transcriptomic analysis. We propose to attempt re-consent of participants.
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    Supplementation tendencies of vitamin C and D among non-severe COVID-19 patients in Blantyre, Malawi
    (Kamuzu University of Health Sciences, 2021-11-21) Katundu, Kondwani
    Study Type: Retrospective cross-sectional quantitative study. Background: Low blood Vitamin C and D have been associated with the severity of Coronavirus disease 2019 (COVID-19). The practice of vitamin supplementation among individuals with non-severe COVID- 19 disease appears to be common, but the frequency and dose of these vitamins among this population group has not been well evaluated in Malawi. Study Objectives: This study aims to determine prevalence and dose of supplementation of the vitamin C and D among non-severe COVID-19 patients in Blantyre, Malawi. Methods: We will conduct a retrospective study in randomly selected recovered non-severe COVID-19 adults (n=150) in Blantyre, Malawi who had a COVID-19 infection between January and September 2021. We will acquire information on the frequency, dose and duration of vitamin C and D supplementation during an episode of the non-severe COVID-19. Sample-size: The sample size for the study will be 150 participants was calculated to detect at least 40% frequency use of vitamin C and D supplementation at a power of 80% and 95% confidence interval. Outcomes and definitions: Vitamin C and D supplementation will be considered as any pharmacological form of the vitamins taken orally or parenterally at least at one point during the sickness episode of nonsevere COVID-19 infection. The prevalence of supplementation, the mean dose and the duration of supplementation will be calculated. Expected findings and dissemination: We expect at least 50% use of vitamin C and D supplementation in individuals with non-severe COVID-19. The results once analysed will be published in an international scientific journal and will be presented both at local and regional or international conferences. Published results will also be submitted to the Malawi Liverpool Welcome Trust Clinical Research Programme, College of Medicine Research and Ethics Committee (COMREC), Kamuzu University of Health Sciences Library, Blantyre District Health and Social Services Office and Queen Elizabeth Central Hospital.
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    Time to death and its predictors among children under 5 years of age with severe acute malnutrition hospitalized at Mulanje district hospital: A retrospective cohort study
    (Kamuzu University of Health Sciences, 2021-11-11) Masuzgo, Pajogo
    Type of the research study: Retrospective Cohort Study Problem to be studied: Severe acute malnutrition (SAM) is defined by a weightfor- height index <-3 z-score or by the presence of nutritional oedema. In children aged 6-59 months, a mid-upper arm circumference <11.5 cm shows SAM. SAM manifests itself in two forms; marasmus, characterized by severe wasting and kwashiorkor, characterized by bilateral pitting oedema. Both marasmus and kwashiorkor contribute significantly to high rates of hospital admission and mortality in childhood. Malawi, has been equally affected by SAM. However, only a handful of studies in Malawi have investigated time to death and its predictors among children under 5 years of age with SAM. Objectives of the study; Broad objective The broad objective of this study is to determine predictors of time to death in children under 5 years of age with SAM admitted at Mulanje District Hospital. Specific objectives i. To determine time to death among children aged 0-59 months admitted between January 2017-February 2021 in the pediatric ward and NRU at Mulanje District Hospital. ii. To compare time to death between admitted children aged 0-59 months who got a SAM diagnosis and/or were managed in the NRU with admitted children who were not diagnosed with SAM /or managed in the NRU at Mulanje District Hospital iii. To identify predictors of time to death among admitted children aged 0-59 months who got a SAM diagnosis and/or were managed in the NRU compared to admitted children who were not diagnosed with SAM and /or managed in the NRU at Mulanje District Hospital. iv. To compare predictors of time to death between admitted children aged 0-59 months who got a SAM diagnosis and/or were managed in the NRU with admittedchildren who were not diagnosed with SAM/or managed in the NRU at Mulanje District Hospital Methodology: This is a retrospective cohort study. The study population is children hospitalized at Mulanje District Hospital between January 2017 to February 2021. We will compare the time to death and its predictors between the exposed group and the unexposed group. The exposed group will contain admitted children who were diagnosed with SAM and managed in NRU. The unexposed group will contain admitted children who were never diagnosed with SAM or were never managed in the NRU. We will collect the archived medical charts from the patient record storage room. We will extract data from the medical charts using data collection forms. Expected findings: We expect children under 5 years of age with SAM to die shortly following admission and will have a higher risk of dying as compared to their counterparts. This is because patients suffering from SAM have nutritionalacquired immune deficiency syndrome (NAIDS), and therefore do not positively respond to medical treatment in the same way as their well-nourished counterparts do. Dissemination of the findings: We will share our findings with the Kamuzu University of Health Sciences, COMREC, Mulanje District Health Office, Communities in Mulanje, and the District Commission. We will also present our findings at local and international research conferences, and in a peer-reviewed publication.