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Topical emollient therapy in the management of severe acute malnutrition in children under two: A randomized controlled clinical trial in Bangladesh.

ABSTRACT: Background:Topical emollient therapy can improve neonatal health and growth and potentially provides an additional avenue for augmenting the provision of nutrition to children with severe acute malnutrition (SAM). We hypothesised that topical treatment of hospitalised children with SAM using sunflower seed oil (SSO), in addition to standard-of-care for SAM, would improve skin barrier function and weight gain, reduce risk of infection, and accelerate clinical recovery. Methods:We conducted a randomised, two-arm, controlled, unblinded clinical trial in 212 subjects aged 2 to 24 months who were admitted for care of SAM at the 'Dhaka Hospital' of icddr,b during January 2016 to November 2017. Enrollment was age-stratified into 2 to <6 months and 6 to 24 months age groups in a 1:2 ratio. All children received SAM standard-of-care, and the SSO group was also treated with 3 g of SSO per kg body weight three times daily for 10 days. Primary outcome was rate of weight gain over the 10-day study period. Secondary endpoints included rate of nosocomial infection, time to recovery from acute illness, skin condition score, rate of transepidermal water loss (TEWL) and C-reactive protein (CRP) level. Results:Rate of weight gain was higher in the SSO than the control group (adjusted mean difference, AMD?=?0.90 g/kg/d, 95% confidence interval (CI)?=?-1.22 to 3.03 in the younger age stratum), but did not reach statistical significance. Nosocomial infection rate was significantly lower in the SSO group in the older age stratum (adjusted odds ratio (OR)?=?0.41, 95% CI?=?0.19 to 0.85; P?=?0.017), but was comparable in the younger age stratum and overall. Skin condition score improved (AMD?=?-14.88, 95% CI?=?-24.12 to -5.65, P?=?0.002) and TEWL was reduced overall (AMD?=?-2.59, 95% CI?=?-3.86 to -1.31, P?

SUBMITTER: Shahunja KM

PROVIDER: S-EPMC7243074 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Topical emollient therapy in the management of severe acute malnutrition in children under two: A randomized controlled clinical trial in Bangladesh.

Shahunja K M KM Ahmed Tahmeed T Hossain Md Iqbal MI Mahfuz Mustafa M Kendall Lindsay L Zhu Xinyi X Singh Krishan K Crowther Jonathan M JM Singh Sunita S Gibson Rachel A RA Darmstadt Gary L GL

Journal of global health 20200601 1

<h4>Background</h4>Topical emollient therapy can improve neonatal health and growth and potentially provides an additional avenue for augmenting the provision of nutrition to children with severe acute malnutrition (SAM). We hypothesised that topical treatment of hospitalised children with SAM using sunflower seed oil (SSO), in addition to standard-of-care for SAM, would improve skin barrier function and weight gain, reduce risk of infection, and accelerate clinical recovery.<h4>Methods</h4>We c ...[more]

PMID: 32509290

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Project description:BackgroundTopical emollient therapy with sunflower seed oil (SSO) reduces risk of sepsis and mortality in very preterm infants in low- or middle-income countries (LMICs). Proposed mechanisms include modulation of skin and possibly gut barrier function. The skin and gut microbiota play important roles in regulating barrier function, but the effects of emollient therapy on these microbiotas are poorly understood.MethodsWe characterised microbiota structure and diversity with 16S rRNA gene amplicon sequence data and ecological statistics in 20 children with severe acute malnutrition (SAM) aged 2-24 months, at four skin sites and in stool, during a randomised, controlled trial of emollient therapy with SSO in Bangladesh. Microbes associated with therapy were identified with tree-based sparse discriminant analysis.ResultsThe skin microbiota of Bangladeshi children with SAM was highly diverse and displayed significant variation in structure as a function of physical distance between sites. Microbiota structure differed between the study groups (P = 0.005), was more diverse in emollient-treated subjects-including on the forehead which did not receive direct treatment-and changed with each day (P = 0.005) at all skin sites. Overall, Prevotellaceae were the most differentially affected by emollient treatment; several genera within this family became more abundant in the emollient group than in the controls across several skin sites. Gut microbiota structure was associated with sample day (P = 0.045) and subject age (P = 0.045), but was not significantly affected by emollient treatment (P = 0.060).ConclusionsEmollient therapy altered the skin microbiota in a consistent and temporally coherent manner. We speculate that therapy with SSO enhances skin barrier function in part through alterations in the microbiota, and through systemic mechanisms. Strategies to strengthen skin and gut barrier function in populations at risk, such as children in LMICs like Bangladesh, might include deliberate manipulation of their skin microbiota.Trial registrationClinicalTrials.gov: NCT02616289.

Project description:BackgroundChildren with severe acute malnutrition (SAM) have inadequate levels of fatty acids (FAs) and limited capacity for enteral nutritional rehabilitation. We hypothesized that topical high-linoleate sunflower seed oil (SSO) would be effective adjunctive treatment for children with SAM.MethodsThis study tested a prespecified secondary endpoint of a randomized, controlled, unblinded clinical trial with 212 children with SAM aged 2 to 24 months in two strata (2 to < 6 months, 6 to 24 months in a 1:2 ratio) at Dhaka Hospital of icddr,b, Bangladesh between January 2016 and December 2017. All children received standard-of-care management of SAM. Children randomized to the emollient group also received whole-body applications of 3 g/kg SSO three times daily for 10 days. We applied difference-in-difference analysis and unsupervised clustering analysis using t-distributed stochastic neighbor embedding (t-SNE) to visualize changes in FA levels in blood from day 0 to day 10 of children with SAM treated with emollient compared to no-emollient.ResultsEmollient therapy led to systematically higher increases in 26 of 29 FAs over time compared to the control. These effects were driven primarily by changes in younger subjects (27 of 29 FAs). Several FAs, especially those most abundant in SSO showed high-magnitude but non-significant incremental increases from day 0 to day 10 in the emollient group vs. the no-emollient group; for linoleic acid, a 237 μg/mL increase was attributable to enteral feeding and an incremental 98 μg/mL increase (41%) was due to emollient therapy. Behenic acid (22:0), gamma-linolenic acid (18:3n6), and eicosapentaenoic acid (20:5n3) were significantly increased in the younger age stratum; minimal changes were seen in the older children.ConclusionsSSO therapy for SAM augmented the impact of enteral feeding in increasing levels of several FAs in young children. Further research is warranted into optimizing this novel approach for nutritional rehabilitation of children with SAM, especially those < 6 months.Trial registrationClinicalTrials.gov : NCT02616289 .

Project description:BackgroundSevere acute malnutrition (SAM) affects about 13 million under-five children (U5), with an estimated one million dying every year. In this study we aimed at determining the in hospital mortality and its associated factors among U5s admitted with SAM.MethodsThis was a prospective cohort study of children 6 months to 5 years with SAM admitted at Mbarara Regional Referral Hospital (MRRH) between June and August 2015. Care-takers were interviewed to collect socio-demographic and clinical information. Children under-went physical examination and had blood drawn for HIV, serum glucose, malaria, full blood count, culture and serum electrolytes investigation. Children were managed according to WHO treatment guidelines for SAM. All participants were followed up for a maximum period of 30 days. The proportion of U5 deaths within the first 48 hours and during the entire admission period was calculated. Using Poisson regression analysis, predictors of in-hospital mortality were analyzed with STATA/IC 11.0.ResultsWe enrolled 122 children, median age of 15 months [IQR:11-24], 58.2% males, 90% immunized, 81% ill for more than 2 weeks before admission, 71% from lower health facilities and majority with unknown HIV status(76%). Overall, 13 (10.7%) children died in hospital. Seven (5.7%) died within the first 48 hours. Intravenous (IV) fluid administration significantly predicted in-hospital mortality (adjusted IRR: 7.2, 95%CI: 2.14-24.08, p = 0.001).ConclusionThe in-hospital mortality in U5s with SAM was lower than that previously reported in central Uganda. Intravenous fluid administration significantly predicted overall in-hospital mortality. While Administration of intravenous fluids is still the main stay of managing severely malnourished children with shock, more research needs to be conducted in order to review the parameters presently used to assess children for shock with a view of diagnosing and managing shock in these children when it is still early. Adequate guidance on use of IV fluids in management of severely malnourished children should be prioritized during continuous medical education for healthcare workers and in the treatment guidelines.

Project description:ObjectiveSevere acute malnutrition (SAM) is a major cause of mortality in children under 5 years and is associated with hepatic steatosis. Bile acids are synthesized in the liver and participate in dietary fat digestion, regulation of energy expenditure, and immune responses. The aim of this work was to investigate whether SAM is associated with clinically relevant changes in bile acid homeostasis.DesignAn initial discovery cohort with 5 healthy controls and 22 SAM-patients was used to identify altered bile acid homeostasis. A follow up cohort of 40 SAM-patients were then studied on admission and 3 days after clinical stabilization to assess recovery in bile acid metabolism. Recruited children were 6-60 months old and admitted for SAM in Malawi. Clinical characteristics, feces and blood were collected on admission and prior to discharge. Bile acids, 7?-hydroxy-4-cholesten-3-one (C4) and FGF-19 were quantified.ResultsOn admission, total serum bile acids were higher in children with SAM than in healthy controls and glycine-conjugates accounted for most of this accumulation with median and interquartile range (IQR) of 24.6 ?mol/L [8.6-47.7] compared to 1.9 ?mol/L [1.7-3.3] (p = 0.01) in controls. Total serum bile acid concentrations did not decrease prior to discharge. On admission, fecal conjugated bile acids were lower and secondary bile acids higher at admission compared to pre- discharge, suggesting increased bacterial conversion. FGF19 (Fibroblast growth factor 19), a marker of intestinal bile acid signaling, was higher on admission and was associated with decreased C4 concentrations as a marker of bile acid synthesis. Upon recovery, fecal calprotectin, a marker of intestinal inflammation, was lower.ConclusionSAM is associated with increased serum bile acid levels despite reduced synthesis rates. In SAM, there tends to be increased deconjugation of bile acids and conversion from primary to secondary bile acids, which may contribute to the development of liver disease.

Dataset Information

Topical emollient therapy in the management of severe acute malnutrition in children under two: A randomized controlled clinical trial in Bangladesh.

Publications

Topical emollient therapy in the management of severe acute malnutrition in children under two: A randomized controlled clinical trial in Bangladesh.

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