protocolSection identificationModule nctId: NCT06356103, orgStudyIdInfo id: 0107060, briefTitle: Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula On Undernourished Neurologically Impaired Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-07-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: Purpose: Undernutrition is common in neurologically impaired children. It increases the burden of comorbidities and affects the quality of life of these children. It must be recognized and treated as early as possible. This study aimed primarily to compare the efficacy of high-caloric whey-based partially hydrolyzed formula (HC-WPHF) versus standard feeding on the nutritional status reflected by growth parameters and feeding tolerance in undernourished children with neurological impairment (NI). The secondary aim was to compare the change in these parameters after using HC-WPHF for 3 and 6 months., conditionsModule conditions: Nutrition Disorder, Child, conditions: Neurologic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Randomized Controlled Study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: High Caloric Whey-Based Partially Hydrolyzed Formula, interventions name: nutritional feeding according to ESPGHAN guidelines, outcomesModule primaryOutcomes measure: To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the weight in kilogram in undernourished children with neurological impairment (NI)., primaryOutcomes measure: To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the height/length in centimeter in undernourished children with neurological impairment (NI)., primaryOutcomes measure: To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the body mass index (BMI) in children with neurological impairment (NI)., primaryOutcomes measure: To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the head circumference in centimeter in undernourished children with neurological impairment (NI), secondaryOutcomes measure: To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the weight in kilogram in undernourished children with neurological impairment (NI) for 3 and 6 months, secondaryOutcomes measure: To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the height/length in Centimeter in undernourished children with neurological impairment (NI) for 3 and 6 months, secondaryOutcomes measure: To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus on the body mass index in undernourished children with neurological impairment (NI) for 3 and 6 months, secondaryOutcomes measure: To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the head circumference in Centimeter in undernourished children with neurological impairment (NI) for 3 and 6 months, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Alexandria University Children Hospital, city: Alexandria, zip: 23445, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False