[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521154":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":31,"collaborators":35,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":28,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":18,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":18,"overallStatus":57,"whyStopped":18,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":63,"leadSponsor":65,"locationsCount":18},{"fullName":5,"class":6},"Medical University of Varna","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"CP with recommended diet","EXPERIMENTAL","CP children that will follow a recommended menu",[13],"Behavioral: Nutrilect",{"label":15,"type":16,"description":17,"interventionNames":18},"CP with a standard of care nutritional menu","NO_INTERVENTION","Children with CP that will not be advised on a specific menu",null,{"label":20,"type":10,"description":21,"interventionNames":22},"ASD with recommended diet","Children with ASD that will not be advised on a specific menu",[13],{"label":24,"type":16,"description":21,"interventionNames":18},"ASD with a standard of care nutritional menu",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":18},"BEHAVIORAL","Nutrilect","This intervention involves a comprehensive approach that includes a thorough nutritional assessment and individualized nutrition plan for children with cerebral palsy (CP) and Autism Spectrum Disorder (ASD), addressing their unique dietary needs and challenges. It encompasses nutritional counseling, dietary modifications when necessary, and seamless integration with other therapies, including speech therapy and psychological consultation. The overarching goal is to optimize growth, muscle function, and overall well-being in these children by providing tailored nutritional support alongside a holistic care approach.",[20,9],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Silviya Pavlova Nikolova, PhD","The research is financed by the European Union-NextGenerationEU, through the National Recovery and Resilience Plan of the Republic of Bulgaria, project № BG-RRP-2.004-0009-C02.",[36],{"name":37,"class":6},"European Union","100521154","randomized-one-center-controlled-trial-on-a-comprehensive-nutritional-intervention-for-children-with-cerebral-palsy-and-asd-100521154",false,"NCT06065904","Randomized One-Center Controlled Trial on a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD","Exploring the Efficacy of a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD: A Randomized Controlled Trial at a Single Center","Inclusion Criteria:\n\n* A formal diagnosis made by a qualified neurologist. The diagnosis can span across the different types of CP and ASD.\n* Expressed willingness to participate in the study.\n* Availability for the entire duration of the study.\n\nExclusion Criteria:\n\n* Children with acute medical conditions or comorbidities that may significantly disrupt study assessments.\n* Any severe infections within the last 10 days prior to the study.\n* Presence of genetic syndromes that could influence nutritional status, e.g., Silver Russel syndrome or Down syndrome.\n* Parents with cognitive impairments, which might pose challenges in their participation during assessments\u002Fintervention.\n* Children who have been part of any major dietary or nutritional interventions in the last three months.","ALL","2 Years","12 Years",{"count":49,"type":50},200,"ESTIMATED","INTERVENTIONAL",[53],"NA","The study is a prospective, single-center, randomized controlled trial that will be conducted at the Medical University of Varna. This setting offers access to a wealth of clinical expertise in managing CP and ASD and a rich tradition of conducting robust nutritional interventions.",[56],"Nutrition Disorder, Child","NOT_YET_RECRUITING","2023-10-01",{"date":60,"type":61},"2023-10-04","ACTUAL",{"date":58,"type":50},{"date":64,"type":50},"2026-07-30",{"name":33,"class":6}]