Is Maternal Body Weight or Composition Associated with Onset of Lactogenesis II, Human Milk Production, or Infant Consumption of Mother's Own Milk? A Systematic Review and Meta-Analysis.

Maternal adiposity impacts lactation performance, but the pathways are unclear. We conducted a systematic review to understand whether maternal adiposity (body mass index [BMI] or percentage fat mass) is associated with onset of lactogenesis II (copious milk; hours), human milk production (expressed volume/24 h), and infant consumption of mother's own milk (volume/24 h). We used random-effects standard meta-analyses to compare the relative risk (RR) of delayed lactogenesis II (>72 h) between mothers classified as underweight (BMI <18.5 kg/m2), healthy weight (BMI, 18.5-24.9 kg/m2), and overweight/obese (BMI ≥25 kg/m2) and random-effects meta-regressions to examine associations with hours to lactogenesis II and infant milk consumption. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach. We included 122 articles. Mothers with underweight (RR: 0.64; 95% CI: 0.49, 0.83; I2 = 39.48%; 8 articles/data points) or healthy weight status (RR: 0.67; 95% CI: 0.57, 0.79; I2 = 70.91%; 15 articles/data points) were less likely to experience delayed lactogenesis II than mothers with overweight/obesity. We found no association between maternal BMI and time to onset of lactogenesis II (ß: 1.45 h; 95% CI: -3.19, 6.09 h; P = 0.52, I2 = 0.00%; 8 articles, 17 data points). Due to limited data, we narratively reviewed articles examining BMI or percentage fat mass and milk production (n = 6); half reported an inverse association and half no association. We found no association between maternal BMI (ß: 6.23 mL; 95% CI: -11.26, 23.72 mL; P = 0.48, I2 = 47.23%; 58 articles, 75 data points) or percentage fat mass (ß: 7.82 mL; 95% CI: -1.66, 17.29 mL; P = 0.10, I2 = 28.55%; 30 articles, 41 data points) and infant milk consumption. The certainty of evidence for all outcomes was very low. In conclusion, mothers with overweight/obesity may be at risk of delayed lactogenesis II. The available data do not support an association with infant milk consumption, but the included studies do not adequately represent mothers with obesity. This study was registered in PROSPERO as 285344.

Micronutrient status in children aged 6-59 months with severe wasting and/or nutritional edema: implications for nutritional rehabilitation formulations.

Undernutrition remains a global struggle and is associated with almost 45% of deaths in children younger than 5 years. Despite advances in management of severe wasting (though less so for nutritional edema), full and sustained recovery remains elusive. Children with severe wasting and/or nutritional edema (also commonly referred to as severe acute malnutrition and part of the umbrella term "severe malnutrition") continue to have a high mortality rate. This suggests a likely multifactorial etiology that may include micronutrient deficiency. Micronutrients are currently provided in therapeutic foods at levels based on expert opinion, with few supportive studies of high quality having been conducted. This narrative review looks at the knowledge base on micronutrient deficiencies in children aged 6-59 months who have severe wasting and/or nutritional edema, in addition to highlighting areas where further research is warranted (See "Future Directions" section).

Human Milk Bioactive Components and Child Growth and Body Composition in the First 2 Years: A Systematic Review.

Human milk (HM) contains macronutrients, micronutrients, and a multitude of other bioactive factors, which can have a long-term impact on infant growth and development. We systematically searched MEDLINE, EMBASE, Cochrane Library, Scopus, and Web of Science to synthesize evidence published between 1980 and 2022 on HM components and anthropometry through 2 y of age among term-born infants. From 9992 abstracts screened, 141 articles were included and categorized based on their reporting of HM micronutrients, macronutrients, or bioactive components. Bioactives including hormones, HM oligosaccharides (HMOs), and immunomodulatory components are reported here, based on 75 articles from 69 unique studies reporting observations from 9980 dyads. Research designs, milk collection strategies, sampling times, geographic and socioeconomic settings, reporting practices, and outcomes varied considerably. Meta-analyses were not possible because data collection times and reporting were inconsistent among the studies included. Few measured infant HM intake, adjusted for confounders, precisely captured breastfeeding exclusivity, or adequately described HM collection protocols. Only 5 studies (6%) had high overall quality scores. Hormones were the most extensively examined bioactive with 46 articles (n = 6773 dyads), compared with 13 (n = 2640 dyads) for HMOs and 12 (n = 1422 dyads) for immunomodulatory components. Two studies conducted untargeted metabolomics. Leptin and adiponectin demonstrated inverse associations with infant growth, although several studies found no associations. No consistent associations were found between individual HMOs and infant growth outcomes. Among immunomodulatory components in HM, IL-6 demonstrated inverse relationships with infant growth. Current research on HM bioactives is largely inconclusive and is insufficient to address the complex composition of HM. Future research should ideally capture HM intake, use biologically relevant anthropometrics, and integrate components across categories, embracing a systems biology approach to better understand how HM components work independently and synergistically to influence infant growth.

Human Milk Macronutrients and Child Growth and Body Composition in the First Two Years: A Systematic Review.

Among exclusively breastfed infants, human milk (HM) provides complete nutrition in the first mo of life and remains an important energy source as long as breastfeeding continues. Consisting of digestible carbohydrates, proteins, and amino acids, as well as fats and fatty acids, macronutrients in human milk have been well studied; however, many aspects related to their relationship to growth in early life are still not well understood. We systematically searched Medline, EMBASE, the Cochrane Library, Scopus, and Web of Science to synthesize evidence published between 1980 and 2022 on HM components and anthropometry through 2 y of age among term-born healthy infants. From 9992 abstracts screened, 57 articles reporting observations from 5979 dyads were included and categorized based on their reporting of HM macronutrients and infant growth. There was substantial heterogeneity in anthropometric outcome measurement, milk collection timelines, and HM sampling strategies; thus, meta-analysis was not possible. In general, digestible carbohydrates were positively associated with infant weight outcomes. Protein was positively associated with infant length, but no associations were reported for infant weight. Finally, HM fat was not consistently associated with any infant growth metrics, though various associations were reported in single studies. Fatty acid intakes were generally positively associated with head circumference, except for docosahexaenoic acid. Our synthesis of the literature was limited by differences in milk collection strategies, heterogeneity in anthropometric outcomes and analytical methodologies, and by insufficient reporting of results. Moving forward, HM researchers should accurately record and account for breastfeeding exclusivity, use consistent sampling protocols that account for the temporal variation in HM macronutrients, and use reliable, sensitive, and accurate techniques for HM macronutrient analysis.

A protocol for a proof-of-concept randomized control trial testing increased protein quantity and quality in ready-to-use therapeutic food in improving linear growth among 6-23-month-old children with severe wasting in Malawi.

INTRODUCTION: Ready-to-use therapeutic foods (RUTFs) have successfully promoted recovery from severe wasting and increased treatment coverage. However, RUTFs do not sufficiently improve linear growth, leaving many survivors of severe wasting at risk of persistent stunting, which is associated with high mortality risk, poor child development and non-communicable diseases in adulthood. High protein quantity and quality can stimulate linear growth. AIM: The trial aims to assess whether higher-protein-RUTF leads to higher concentrations of markers of linear growth compared to standard RUTF among 6-23 months old children with severe wasting. METHODS: We designed a higher protein quantity and quality RUTF for a proof-of-concept (PoC) double-blind randomized controlled trial. OUTCOMES: The primary outcome is a change in insulin-like growth factor-1 (IGF-1), a hormone positively associated with linear growth after four weeks of treatment. Secondary outcomes include changes in ponderal and linear growth and in body composition from baseline to eight weeks later; plasma amino acid profile at four weeks; acceptability and safety. IMPLICATIONS: These findings will help in informing the potential impact of increased protein in RUTF on linear growth when treating severe wasting towards conducting a larger clinical trial. TRIAL REGISTRATION: The trial has been registered on clinicaltrial.gov (NCT05737472).

Eating Behaviors, Caregiver Feeding Interactions, and Dietary Patterns of Children Born Preterm: A Systematic Review and Meta-Analysis.

Infants born preterm (<37 weeks of gestation) often experience feeding problems during hospitalization. Whether difficulties persist or have long-term sequelae on childhood eating is unclear. We aimed to describe the oromotor eating skills (e.g., chewing/swallowing), eating behaviors (e.g., food neophobia), food parenting practices (e.g., pressure to eat), and dietary patterns of preterm children during late infancy (6-12 mo) and early childhood (>12 mo-7 y) and to determine whether these differed from those of term-born peers. We identified 67 articles (57 unique studies) for inclusion. We used random-effects meta-analysis of proportions to examine the prevalence of oromotor eating skill and eating behavior challenges among preterm children, standard meta-analysis for comparisons with term-born peers, and the Grading of Recommendations, Assessment, Development and Evaluation approach to assess the certainty of evidence. Forty-three percent (95% CI: 24%, 62%) of infants and 25% (95% CI: 17%, 33%) of children born preterm experienced oromotor eating difficulties and 16% (95% CI: 4%, 27%) and 20% (95% CI: 11%, 28%), respectively, exhibited challenging eating behaviors. During late infancy and early childhood, oromotor eating difficulties (OR: 2.86; 95% CI: 1.71, 4.77; I2 = 67.8%) and challenging eating behaviors (OR: 1.52; 95% CI: 1.11, 2.10; I2 = 0.0%) were more common in those born preterm than in those born term: however, the certainty of evidence was very low. Owing to the low number and heterogeneity of studies, we narratively reviewed literature on food parenting and dietary patterns. Mothers of preterm infants appeared to have heightened anxiety while feeding and utilized coercive food parenting practices; their infants reportedly received less human milk, started solid foods earlier, and had poorer diet quality than term-born peers. In conclusion, meta-analyses show preterm children experience frequent oromotor eating difficulties and challenging eating behaviors throughout the early years. Given preterm birth increases risk of later obesity and diet-related chronic disease, research examining the effects of caregiver-child interactions on subsequent diet is warranted. This review was registered at www.crd.york.ac.uk/prospero/ as CRD42020176063.

Pathways between caregiver body mass index, the home environment, child nutritional status, and development in children with severe acute malnutrition in Malawi.

Children with severe acute malnutrition (SAM) remain vulnerable after treatment at nutritional rehabilitation units (NRUs). The objective was to assess the concurrent pathways in a hypothesized model between caregiver body mass index (BMI), the home environment, and child nutritional status, and development (gross motor, fine motor, language, and social domains) in children with SAM following discharge from inpatient treatment. Structural equation modelling (SEM) was performed with data from a cluster-randomized controlled trial at the Moyo Nutritional Rehabilitation and Research Unit in Blantyre, Malawi. This approach was undertaken to explore simultaneous relationships between caregiver BMI, the home environment (Home Observation for Measurement of the Environment Inventory scores), child nutritional status (anthropometric indicators including weight-for-age z-scores [WAZ]), and child development (Malawi Developmental Assessment Tool (MDAT) z-scores as a latent variable) in children with SAM. These data were collected at participants' homes six months after discharge from NRU treatment. This analysis included 85 children aged 6-59 months with SAM and their caregivers recruited to the trial at the NRU and followed up successfully six months after discharge. The model with WAZ as the nutritional indicator fit the data according to model fit indices (χ2 = 28.92, p = 0.42). Caregiver BMI was predictive of better home environment scores (ß = 0.23, p = 0.03) and child WAZ (ß = 0.30, p = 0.005). The home environment scores were positively correlated with MDAT z-scores (ß = 0.32, p = 0.001). Child nutritional status based on WAZ was also correlated with MDAT z-scores (ß = 0.37, p<0.001). This study demonstrates that caregiver BMI could ultimately relate to child development in children with SAM, through its links to the home environment and child nutritional status.

A Mixed-Methods Cluster-Randomized Controlled Trial of a Hospital-Based Psychosocial Stimulation and Counseling Program for Caregivers and Children with Severe Acute Malnutrition.

BACKGROUND: Children with severe acute malnutrition (SAM) who require nutritional rehabilitation unit (NRU) treatment often have poor developmental and nutritional outcomes following discharge. The Kusamala Program is a 4-d hospital-based counseling program for caregivers of children with SAM that integrates nutrition, water, sanitation, and hygiene and psychosocial stimulation, aimed at improving these outcomes. OBJECTIVES: The aim was to evaluate the effects of the Kusamala Program on child development and nutritional status in children with SAM 6 mo after NRU discharge. The other aim was to qualitatively understand perceptions and experiences of caregivers who participated in the intervention. METHODS: A cluster-randomized controlled trial was conducted with caregivers and their children 6-59 mo of age with SAM admitted to the Moyo NRU in Blantyre, Malawi. The primary outcome of the trial was child development according to Malawi Developmental Assessment Tool (MDAT) composite z-scores of gross motor, fine motor, language, and social domains. A qualitative component with focus group discussions and in-depth interviews was also completed with a subset of caregivers who participated in the trial. RESULTS: Sixty-eight caregivers and children were enrolled to clusters by week and randomly assigned to the comparison arm and 104 to the intervention arm. There were no differences in child development, with mean MDAT composite z-scores in the comparison arm of -1.2 (95% CI: -2.1, -0.22) and in the intervention arm of -1.1 (95% CI: -1.9, -0.40) (P = 0.93). The qualitative evaluation with 20 caregivers indicated that the 3 modules of the Kusamala Program were appropriate and that they applied many of the lessons learned at home as much as possible. CONCLUSIONS: The Kusamala Program did not result in improved developmental or nutritional outcomes, yet it was viewed positively by caregivers according to qualitative results. Future research should evaluate more intensive interventions for caregivers and children with SAM. This trial was registered at www.clinicaltrials.gov as NCT03072433.

Ready-to-Use Therapeutic Food (RUTF) Containing Low or No Dairy Compared to Standard RUTF for Children with Severe Acute Malnutrition: A Systematic Review and Meta-Analysis.

Ready-to-use therapeutic food (RUTF) containing less dairy may be a lower-cost treatment option for severe acute malnutrition (SAM). The objective was to understand the effectiveness of RUTF containing alternative sources of protein (nondairy), or <50% of protein from dairy products, compared with standard RUTF in children with SAM. The Cochrane Library, MEDLINE, Embase, CINAHL, and Web of Science were searched using terms relating to RUTF. Studies were eligible if they included children with SAM and evaluated RUTF with <50% of protein from dairy products compared with standard RUTF. Meta-analysis and meta-regression were completed to assess the effectiveness of intervention RUTF on a range of child outcomes. The quality of the evidence across outcomes was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. A total of 5868 studies were identified, of which 8 articles of 6 studies met the inclusion criteria evaluating 7 different intervention RUTF recipes. Nondairy or lower-dairy RUTF showed less weight gain (standardized mean difference: -0.20; 95% CI: -0.26, -0.15; P < 0.001), lower recovery (relative risk ratio: 0.93; 95% CI: 0.87, 1.00; P = 0.046), and lower weight-for-age z scores (WAZ) near program discharge (mean difference: -0.10; 95% CI: -0.20, 0.0; P = 0.047). Mortality, time to recovery, default (consecutive absences from outpatient therapeutic feeding program visits), nonresponse, and other anthropometric measures did not differ between groups. The certainty of evidence was high for weight gain and ranged from very low to moderate for other outcomes. RUTF with lower protein from dairy or dairy-free RUTF may not be as effective as standard RUTF for treatment of children with SAM based on weight gain, recovery, and WAZ evaluated using meta-analysis, although further research is required to explore the potential of alternative formulations. This review was registered at https://www.crd.york.ac.uk/prospero/ as CRD42020160762.

Maternal BMI is positively associated with human milk fat: a systematic review and meta-regression analysis.

BACKGROUND: Lack of robust estimates of human-milk nutrient composition and influential maternal factors, such as body composition, are barriers to informing nutrition policies and programs. OBJECTIVE: The objective was to understand the relation between maternal BMI and human-milk energy, fat, and/or total protein. METHODS: Four electronic databases (MEDLINE, Embase, CINAHL, and Web of Science) were searched. Outcomes assessed were human-milk energy (kcal/L), fat (g/L), and total protein (g/L) from mothers 1 to 6 mo postpartum. Studies with data on maternal BMI or weight and height that quantified human-milk energy, fat, or protein between 1 and 6 mo postpartum were eligible. Random-effects meta-regression weighted by the inverse of the study-level SE was completed for each of the 3 outcomes. The certainty of evidence for each outcome was assessed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. RESULTS: A total of 11,373 titles and abstracts were identified, and after full-text screening, 69 articles of 66 studies were included. Meta-regression results showed a positive association between maternal BMI and human-milk fat (ß: 0.56 g/L; 95% CI: 0.034, 1.1; P = 0.04; I2 = 93.7%, n = 63 datapoints). There was no significant association between maternal BMI and human-milk energy (ß: 3.9 kcal/L; 95% CI: -1.6, 9.5; P = 0.16, I2 = 93.3%, n = 40 datapoints) or total protein (ß: 0.13 g/L; 95% CI: -0.16, 0.41; P = 0.37, I2 = 99.1%, n = 40 datapoints). The certainty of evidence for human-milk energy was low and the certainty of evidence for fat and total protein was very low. CONCLUSIONS: Meta-regression analysis of available literature suggested an association between maternal BMI and human-milk fat between 1 and 6 mo postpartum. Future studies are needed to confirm the relation between maternal BMI; variation in human-milk energy, fat, and protein content; and the implications for child growth and development. This review is registered with International Prospective Register of Systematic Reviews (PROSPERO 2018 CRD42018098808) at https://www.crd.york.ac.uk/prospero/.

Dysglycemia in Children with Severe Acute Malnutrition: A Systematic Review and Meta-Analysis.

Dysglycemia is a common complication of severe acute malnutrition (SAM) in children. Its prevalence and impact on short- and long-term outcomes are not well described. This systematic review was undertaken to review the available evidence on dysglycemia (either hypo- or hyperglycemia) in hospitalized children with SAM. The 2 primary objectives of this systematic review were to understand the prevalence of hypoglycemia and hyperglycemia in children with SAM. A secondary objective was to understand the relation between dysglycemia and clinical outcomes like mortality in children with SAM. MEDLINE was searched with terms related to children, SAM, and dysglycemia. A meta-analysis of proportions was completed to determine the hypoglycemia prevalence and a standard meta-analysis was done to determine the relation between hypoglycemia and mortality. The certainty of the evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. A total of 2148 articles were identified in the database search of which 16 met the inclusion criteria for the systematic review based on screening done by multiple reviewers. The overall prevalence of hypoglycemia in SAM across studies based on the meta-analysis of proportions was 9% (95% CI: 7%, 12%; I2 = 92%). Meta-analysis results showed that hypoglycemia was associated with a higher chance of mortality during hospitalization in children with SAM (OR: 4.29; 95% CI: 3.04, 6.05; I2 = 0%). According to the GRADE evaluation, the certainty of the evidence for the prevalence of hypoglycemia was low and for hyperglycemia was very low. For the relation between hypoglycemia and mortality, the certainty of the evidence was moderate. A meta-analysis was not carried out for the prevalence of hyperglycemia due to the wide range of definitions used for across studies, but the prevalence ranged from 2% to 38% in the literature. This systematic review highlights the need for further work in this area to include serial glucose measurements to understand the clinical importance of dysglycemia during hospitalization in children with SAM.

The introduction of a paediatric nutrition support program led by a clinical dietitian at a low-resource hospital setting in Malawi.

In low- and middle-income countries, nutrition support strategies are often suboptimal or non-existent in hospital settings. This is further compounded by high rates of malnutrition in these countries. The first four dietitians graduated in Malawi in 2017 providing a new opportunity to build capacity to introduce nutrition support in an acute care setting. A paediatric nutrition support program was implemented at Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi including the hiring of a local dietitian. This capacity building paper explains the development and introduction of the nutrition support program including a description of perceptions of health professionals at QECH working alongside the dietitian. In the first four months of the program at QECH, the dietitian provided nutrition support to 183 different patients across paediatric wards. Nutritional interventions predominantly included infant formula and breastmilk fortification, provision of therapeutic feeds orally or via nasogastric tubes, increased dietary protein intake for children identified to be at high risk, and nutritional counselling to caregivers. More complex nutritional interventions were also given such as the insertion of gastrostomy tubes to deliver nutrition directly to the stomach. Following the introduction of the program, qualitative interviews were done with health professionals at QECH including nurses (n = 5) and physicians (n = 11). All participants emphasized the importance and impact of the nutrition support program in enhancing the care of hospitalized children, therefore improving outcomes such as tolerability of clinical interventions, decreased duration of stay, and reduced risk of hospital readmission. In conclusion, there is a need for nutrition support provided by a dietitian for different paediatric patients which was corroborated by positive feedback from health professionals at QECH. Integration of dietitians into the healthcare system by respective Ministries of Health will require advocacy around the potential for nutrition support to strengthen the quality of care of vulnerable children. A Chichewa abstract for this paper is available in a supplementary file.

Urinary Organic Acids Increase After Clinical Stabilization of Hospitalized Children With Severe Acute Malnutrition.

BACKGROUND: Despite a reduction of child mortality in low-income countries, acutely ill undernourished children still have an elevated risk of death. Those at highest risk are children with severe acute malnutrition (SAM) who often show metabolic dysregulation that remains poorly understood. OBJECTIVE: We performed a pilot study to examine changes in urinary organic acids during nutritional rehabilitation of children with SAM, and to identify metabolites associated with the presence of edema or with mortality. METHODS: This study included 76 children aged between 6 and 60 months, hospitalized for SAM at the Moyo Nutritional Rehabilitation and Research Unit in Blantyre, Malawi. Urine was collected at admission and 3 days after clinical stabilization and metabolomics were performed using gas chromatography-mass spectrometry. Metabolite concentrations were evaluated with both uni- and multivariate approaches. RESULTS: Most metabolites increased 3 days after clinical stabilization, and total urinary concentration changed from 1.2 mM (interquartile range [IQR], 0.78-1.7) at admission to 3.8 mM (IQR, 2.1-6.6) after stabilization (P < .0001). In particular, 6 metabolites showed increases: 3-hydroxybutyric, 4-hydroxyhippuric, p-hydroxyphenylacetic, oxoglutaric, succinic, and lactic acids. Urinary creatinine was low at both time points, but levels did increase from 0.63 mM (IQR, 0.2-1.2) to 2.6 mM (IQR,1.6-4.4; P < .0001). No differences in urinary profiles were found between children who died versus those who survived, nor between children with severe wasting or edematous SAM. CONCLUSIONS: Total urinary metabolites and creatinine increase after stabilization and may reflect partial recovery of overall metabolism linked to refeeding. The use of urinary metabolites for risk assessment should be furthered explored. TRIAL REGISTRATION: TranSAM study (ISRCTN13916953).

A quantitative cross-sectional survey of psychosocial stimulation and counselling interventions at nutritional rehabilitation units in Southern Malawi.

Background: Inpatient treatment at nutritional rehabilitation units (NRUs) is needed for children who have severe acute malnutrition (SAM) and acute illness, loss of appetite, or severe oedema. World Health Organization guidelines state that nutritional counselling should be done with primary caregivers at NRUs. These recommendations also include psychosocial stimulation interventions to improve developmental outcomes in children with SAM. However, there is limited information about the delivery of these types of interventions for caregivers and children in NRU settings. The primary objective of this research was therefore to obtain data about NRU resources, activities, and protocols relevant to psychosocial stimulation and counselling interventions during inpatient treatment of children with SAM. Methods: A cross-sectional survey was administered by interview at all 16 NRUs in seven districts in Southern Malawi. Participants were health workers, nurses, and nutritionists employed at the respective NRUs. Results: The response rate was 100% across NRUs. Half of participants said that psychosocial stimulation interventions are conducted at their respective NRUs, yet none of the NRUs have protocols for delivery of these interventions. Furthermore, 7/16 (44%) NRUs have no resources for psychosocial stimulation including play materials. Thirteen of 16 (81%) participants said that they feel this type of intervention is very important and 3/16 (19%) participants said that this somewhat important for children with SAM. All NRUs provide counselling to caregivers about breastfeeding and nutrition; 15/16 (94%) also give counselling about water, sanitation and hygiene. Conclusions: Ultimately, results from this survey highlighted that there is a need to invest in comprehensive interventions to improve developmental and nutritional outcomes in these vulnerable children requiring admission to NRUs.

A mixed methods feasibility study of the Kusamala Program at a nutritional rehabilitation unit in Malawi.

BACKGROUND: Children admitted to nutritional rehabilitation units (NRUs) for inpatient treatment of severe acute malnutrition (SAM) are at high risk of poor developmental and nutritional outcomes. The Kusamala Program is an interactive hospital-based counseling program for primary caregivers of children with SAM that integrates three modules: nutrition and feeding; water, sanitation, and hygiene (WASH); and psychosocial stimulation. This mixed methods feasibility study aimed to evaluate the implementation of the Kusamala Program in an NRU setting and developmental outcomes in children with SAM 6 months after inpatient treatment. METHODS: An internal pilot trial including the first 30 children and their primary caregivers enrolled to a cluster-randomized controlled trial of the Kusamala Program was performed. Barriers and enablers were identified in a qualitative study with a focus group discussion (FGD) and in-depth interviews (IDIs) with 12 hospital staff members, including five NRU nurses who deliver the Kusamala Program. RESULTS: Results demonstrated high participant engagement (100%) and adherence (87%) of primary caregivers to the Kusamala Program. Potential barriers to implementation identified through the qualitative study were caregivers' perceived value of the program, prioritization of other ward activities, and shortages of staff. On the other hand, enablers to implementation were engaging other staff members, motivation and work ethic, and refresher training. CONCLUSIONS: This mixed methods study demonstrates the feasibility of implementing the Kusamala Program in a real NRU setting. The full cluster-randomized controlled trial will be completed to evaluate the effectiveness of the Kusamala Program. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03072433. Registered on 7 March 2017-retrospectively registered.

Perceptions and experiences of caregivers of severely malnourished children receiving inpatient care in Malawi: An exploratory study.

Background: Severe acute malnutrition (SAM) affects approximately 18 million children under the age of five and is associated with more than 500 thousand deaths per year. Existing research has indicated that a high number of caregivers of children admitted for inpatient treatment of SAM experience psychological distress, depressive symptoms, and suicidality. However, no published studies in Malawi have been undertaken to qualitatively explore caregivers' perceptions and experiences regarding their children's malnutrition and inpatient treatment. Aim: To explore caregivers' perceptions and experiences surrounding childhood acute malnutrition and the experience of inpatient care in Malawi. Methods: Interviews were conducted utilising a semi-structured topic guide and were coded using thematic analysis. Results: Caregivers (N=30) gave informed consent to participate in interviews. Caregiver understanding and perceptions of their children's illness varied. Some caregivers identified a physical cause, with a minority identifying lack of dietary protein. Other narratives were around characteristics of the infant, other circumstantial events and religious and spiritual influences. One-third of caregivers described their own health difficulties and marital and relationship stressors. Challenges such as poverty, lack of access to food, poor food variability and competing demands for caregiver time were explained. Both positive and negative experiences of family and community support and hospital-based care were reported. Conclusion: The themes identified contribute to a greater contextual understanding of the multifactorial and integrated approaches required to address malnutrition. This study indicates that healthcare providers need to take a multi-faceted view of malnutrition and be aware of the many factors that may influence healthcare experience and response to treatment. Acknowledging pluralistic belief systems may improve engagement with care. This demands a broader appreciation of perceptions and experiences of malnutrition, hospital-based care, sources of support and stressors within the caregiver, family and community environment as well as consideration of social determinants such as poverty and how these influences present within a clinical context.

The Kusamala Program for primary caregivers of children 6-59 months of age hospitalized with severe acute malnutrition in Malawi: study protocol for a cluster-randomized controlled trial.

BACKGROUND: Severe acute malnutrition (SAM) is associated with high mortality rates and impairments in growth and development in children that do survive. There are complex nutritional, health, and behavioural risk factors involving severely malnourished children and their primary caregivers, requiring integrated intervention approaches. METHODS: A cluster-randomized controlled trial at the Queen Elizabeth Central Hospital in Blantyre, Malawi will be conducted to evaluate the effectiveness of a 4-day hospital-based intervention programme directed at primary caregivers. This programme, titled the Kusamala Program, aims to improve developmental and nutritional outcomes in children with SAM. Up to six primary caregivers and their children will be enrolled to groups each week, which will be randomly allocated to intervention or comparison arms. The intervention package consists of interactive counselling on three modules: 1) nutrition and feeding; 2) water, sanitation, and hygiene (WASH); and 3) psychosocial stimulation. Data collection will be performed at enrolment, at discharge from hospital, and at 6 months following discharge. The primary outcome is child development assessed with the Malawi Developmental Assessment Tool (MDAT), a validated measure of gross and fine motor, language, and social development. DISCUSSION: This intervention programme is unique because it utilizes primary caregivers' time spent in-hospital while children receive treatment for SAM. The programme has the potential to be effective in addressing multiple aspects of child, nutrition and development. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03072433 . Registered on 7 March 2017.