[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-wasting\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-wasting":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100582940","milk-fat-globule-membrane-enhanced-rutf-for-children-with-severe-acute-malnutrition-100582940",false,"NCT06869850","Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition","MFGM-EnhaNceD RUTF for Children With SAM","MEND-SAM","Inclusion Criteria:\n\n* 6-59 months of age\n* Reside within the catchment area of a participating clinic\n* mid-upper arm circumference \\\u003C 11.5 cm and\u002For weight-for-length z-score \\\u003C -3 and\u002For presence of bilateral pedal pitting edema\n* willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic\n\nExclusion Criteria:\n\n* Features of complicated SAM: inability to tolerate a 30 g test dose of RUTF, breathing difficulties, mental status changes, sepsis, diarrhea with severe dehydration, and\u002For physician\u002Fnursing clinical assessment that the child needs immediate hospitalization\n* Participation in a separate therapeutic feeding program within the past month\n* Known allergy to study food ingredient (peanut, milk, fish)\n* Clinically evident developmental delay (most often determined based on research nursing assessment of physical appearance, movement, and informal discussion with caregiver)\n* Presence of a chronic severe medical condition (other than tuberculosis and HIV), such as congenital heart disease","ALL","6 Months","59 Months",{"count":21,"type":22},1600,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to test the use of milk fat globule membrane (MFGM) in ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition in Sierra Leone. The main questions it aims to answer are:\n\n* Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition improve their neurodevelopment?\n* Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition reduce its worst consequences: death, hospitalization, and remaining severely malnourished despite treatment?\n\nResearchers will compare the MFGM-containing RUTF to standard RUTF, which contains skim milk powder.\n\nParticipants will:\n\n* undergo measurement of length, weight, mid-upper arm circumference, and nutritional edema assessment every two weeks during severe malnutrition treatment\n* be treated with either MFGM-RUTF or standard RUTF at a dose of 2 sachets per day for up to 12 weeks\n* undergo neurodevelopmental testing using the Malawi Developmental Assessment Tool at the end of SAM treatment and 6 months later\n* a subset of participants will undergo blood spot collection and stool sample collection",[28,29,30,31],"Severe Acute Malnutrition","Cognitive Impairment","Kwashiorkor","Severe Wasting",[33,34,35,36,37,38,39,40,41,42,43],"severe acute malnutrition","severe wasting","kwashiorkor","milk fat globule membrane","neurodevelopment","phospholipids","ganglioside","dairy fat","malawi developmental assessment tool","Sierra Leone","ready-to-use therapeutic food","RECRUITING","2025-12-16",{"date":47,"type":48},"2025-12-17","ACTUAL",{"date":50,"type":48},"2025-09-22",{"date":52,"type":22},"2027-12-01",{"name":54,"class":55},"Washington University School of Medicine","OTHER",10]