View clinical trials related to Severe Malnutrition.
Filter by:This study compares the effect of human recombinant Granulocyte-Colony Stimulating Factor (G-CSF) in pediatric patients with liver cirrhosis with a control group. The study aims to observe improvement of (Pediatric End-stage Liver Disease) PELD score and nutritional status prior to liver transplantation procedure. In addition to the intervention, standard treatments for liver cirrhosis are also given for both groups. G-CSF is administered for 12 times. Condition of disease: Pediatric patient aged 3 months to 12 years old Liver cirrhosis Undernourished / Severe malnutrition PELD score 10-25 Intervention: Drug: Recombinant Human G-CSF Phase: Phase 3
Severe tuberculosis (TB) leads to wasting and anorexia, increasing risk of the refeeding syndrome (RFS) as defined by current criteria. TB patients have high metabolic rates and require a high calorie diet, with nutritional supplementation programs improving outcomes. BMI inversely correlates with mortality in these patients. Risk of RFS, a life-threatening syndrome associated with initiation of feeding after a period of low intake, has not been studied in this population and it is not known whether severely malnourished TB patients benefit from lower caloric intake. This study aimed to examine the prevalence of RFS in TB inpatients in rural India and correlate this with baseline and inpatient caloric intake.
Introduction: Protein energy malnutrition is one of the strongest predictors of morbidity and mortality in maintenance hemodialysis (MHD) patients. Many reports indicate that there is a high prevalence of malnutrition up to 40% , and has a strong association with inflammation and cardiovascular disease (CVD) as well as lower quality of life in this population. The aim of this study was to compare the nutritional modalities by means of biochemical parameters, arterial stiffness and bioimpedance analysis. Material and Methods: We designed an observational study with 56 malnourished MHD patients (mean age: 61.8±12.3 years, duration of hemodialysis: 7.9±5.1 years) . Patients were distributed into 4 groups according to patients requests for nutritional support modalities. We offered the combination of oral nutritional support (ONS) and intradialytic parenteral nutrition (IDPN) to all patients however some of the patients refused this combination thus we had 4 groups as; Group 1 (patients received only ONS and refused parenteral nutrition; n: 14), group 2 (patients received only parenteral NS and refused ONS; n: 14), group 3 (patients received both oral and parenteral NS; n: 10) and group 4 (dietetic support group; patients who refused all types of nutritional support and only followed by counselling, n: 18) for 12 months. Biochemical parameters were assessed from monthly clinical visits. Normalized protein catabolic rate (nPCR), malnutrition-inflammation score (MIS), body composition (fat mass [FM], fat-free mass (FFM) muscle mass (MM, body mass index (BMI)) by multifrequency bioimpedance analysis (BCM, Fresenius).
HYPOTHESIS: Investigators hypothesize that by provision of care at household level in a community through lady health workers will as effective (recovery rate, burden of SAM, cost effective, coverage) as through health care providers at facility level. OBJECTIVES 1. To evaluate the effectiveness (rate of recovery, burden & coverage), of SAM standard management of children 06-59 months delivered at household level by first level health care providers (Lady health workers) compared with the standard CMAM program delivered at health facility by Govt./ACF staff. 2. To evaluate the cost effectiveness of treatment of SAM provided by LHWs at community level versus treatment delivered at health facility by Govt/ACF staff. STUDY DESIGN: Cluster randomized controlled trial SAMPLE SIZE & RANDOMIZATION: Investigators took 6% prevalence to calculate the sample size with an expected reduction of 20%. A sample size of 3 clusters per group with 150 individuals per cluster is needed. STUDY METHODOLOGY Intervention (Group A): LHWs will identify and treat all cases of severe acute malnutrition (SAM) as per the study eligibility criteria (MUAC < 11.5 cm) and manage all cases of SAM without complications at home following the national CMAM guidelines. Control (Group B): LHWs will identify SAM as per the CMAM guidelines (MUAC < 11.5 cm) and will refer all cases to the health facility (ACF) for further management and counselling by health workers at facility.
Children with complicated severe acute malnutrition (SAM), such as inability to take adequate feeds, infection and diarrhoea, require in-patient management. Despite following a well-established World Health Organisation (WHO) protocol, outcomes are poor. Case fatality often exceeds 20%. Amongst survivors discharged home, many subsequently die, have long-term poor growth or recurrence of SAM. It has long been recognized that children with SAM have intestinal inflammation and that this persists despite management according to WHO guidelines. The inflammation is thought to result from increased exposure to microbial pathogens in the gut in areas with poor sanitation. The damaged lining of the intestine impairs food digestion and absorption, likely allows gut bacteria to enter the blood stream to cause sepsis and also exposes the gut immune cells to microbial and food antigens causing the inflammation to persist. Failure to treat the intestinal inflammation is likely to contribute to the poor response to treatment and poor long-term outcomes in many children with SAM. The intestinal inflammation seen in SAM is very similar to that which occurs in food intolerance (e.g. intolerance to cow's milk protein) and inflammatory bowel disease. In these conditions, the inflammation is treated very effectively with hypoallergenic ("elemental") and anti-inflammatory ("polymeric") formulas. These are nutritionally complete feeds that have a similar composition to the feeds used for nutritional rehabilitation in SAM. We aim to undertake a pilot study to see if an elemental and/or polymeric formula are tolerated by children with SAM and help to reduce intestinal inflammation. We also aim to learn more about the intestinal inflammation in general that occurs in SAM by observing carefully the effect of these specific formulae and to do in-depth metabolic analyses.
The objective of the research is to assess the effectiveness of adding a Household WASH component to the standard outpatient treatment of severe acute malnutrition. Study design: cluster-randomized controlled trial comparing two interventions: 1. Control group: outpatient management of children diagnosed for severe acute malnutrition only 2. Intervention group: outpatient management of children diagnosed for severe acute malnutrition + "household WASH package" 2000 children, aged between 6 and 59 months, admitted to 20 OTP (Outpatient Therapeutic Program) centers for SAM will be included into the study and followed for 8 months (2 months of treatment, and 6 months after successful discharge).
Cash transfer, aims to strengthen food security for vulnerable households by giving families enough purchasing power to consume an adequate and balanced diet, maintain a good standard of hygiene, access health services, and invest in their own means of food production in addition to their children's growth and development. While cash transfer to vulnerable households has shown a long-term positive impact on growth and on malnutrition-related mortality in children aged 0-5 years, there is little conclusive evidence their effectiveness in Sub-Saharan Africa that cash transfer has a direct effect on the Community-based Management of Acute Malnutrition (CMAM). Here, the investigators will perform a cluster-randomized trial to investigate during 6 months the effects of unconditional cash transfers on the management of severe acute malnutrition (SAM) in children from 6 to 59 months according to the national protocol in the Democratic Republic of Congo.
The investigators performed two case-control studies in Niger and Senegal analysing fecal microbiota to characterize the specificity of the gut microbiota alteration associated with severe acute malnutrition (SAM).
The purpose of this study is to assesses the effectiveness of an integrated model for the management of severe acute malnutrition (IM-SAM) in India comprising facility- and community-based care and using locally-adapted protocols
Severe malnutrition is associated with a high rate of mortality, even when using the latest WHO recommendations. Watery diarrhea as observed in cholera is an additional vital risk to those children. The fragility of the children together with the complexity of the pathophysiology and the simplicity of the medical environment where the treatment is delivered are serious constraints for the development of new therapies. Dehydration is a special immediate risk in those children who already displayed altered body distribution of water with potassium, magnesium, zinc and other nutrient deficiency. Dehydration is also often associated with a decrease in appetite. In addition, the intestinal function is altered both by the infectious agent and the nutritional status of the child. Recommended therapy for those children comprises oral rehydration with ReSoMaL (modified ORS for use in severely malnourished children recommended by WHO), at a relatively low rate, with permanent monitoring; in addition, breastfeeding should not be interrupted and feeding with F100 (Milk based formula diet for use in severely malnourished children recommended by WHO) is recommended. Recently, amylase-resistant starch added to a standard WHO-ORS has been shown to reduce the duration and severity of adults with cholera. The rationale for using amylase-resistant starch was that when starch enters the colon it is metabolized by the bacteria. The short-chain fatty acids thus produced stimulate sodium absorption in the colon, just like glucose stimulates water absorption in the small intestine. In addition, this treatment would be of particular interest in malnutrition because short-chain fatty acids are specific energetic substrate for the colon.In the present project, we propose to test the hypothesis that addition of amylase-resistant starch to the already recommended treatment of severely malnourished children with cholera reduces the severity and duration of diarrhea; this could be achieved through the effect of short-chain fatty acids on colonic sodium absorption. In addition, a better recovery from malnutrition could be achieved through the energy provided by short-chain fatty acids to the colon and improved appetite through improved rehydration. Thus, the aim of the study is to measure the effect of amylase-resistant starch added to an already accepted treatment (with minimal changes) at the rehydration and rehabilitation phases of the treatment. A total of 210 children aged 6 mo to 60 mo will be studied in three groups : a) glucose based ORS and amylase-resistant starch; b) glucose based ORS without amylase resistant starch ; c) rice based ORS . The major outcome variables on the first phase (diarrhoeal duration and stool output), and second phase (food intake, weight gain) will be compared between the two treatment groups. The result of the study if found effective in reducing the duration of diarrhoea, enhance recovery from diarrhoea and malnutrition in severely malnourished children, will contribute to better case management of these children.