protocolSection identificationModule nctId: NCT06345664, orgStudyIdInfo id: 548/2022BO1, briefTitle: Interdisciplinary E-health Based Follow-up of Preterm Born Children, acronym: NeoUp, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: The aim of the study is to assess mental and somatic symptoms of preterm born children at the ages of 2, 5 and 10 by a multidisciplinary team and to evaluate an app that screens for these symptoms. Furthermore, there will be an evaluation of an intervention by our multidisciplinary team that provides recommendations for further treatment and diagnostic procedures of the children., conditionsModule conditions: Preterm Birth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostics and intervention recommendations, outcomesModule primaryOutcomes measure: Bayley Scales of Infant and Toddler Development, primaryOutcomes measure: Wechsler Intelligence Scale for Children (WISC-V), primaryOutcomes measure: Children's Sleep Habit Questionnaire (CSHQ-DE 4-10), primaryOutcomes measure: Sleep Self Report (SSR), primaryOutcomes measure: Somatics, primaryOutcomes measure: Child Behavior Checklist (CBCL), primaryOutcomes measure: Youth Self Report (YSR), primaryOutcomes measure: Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB), primaryOutcomes measure: KIDSCREEN-27 (The KIDSCREEN), primaryOutcomes measure: Parent's Stress Inventory (EBI), primaryOutcomes measure: App-questions, primaryOutcomes measure: Postexperimental questionnaire, secondaryOutcomes measure: Demographic data, secondaryOutcomes measure: Actigraphy measurement, secondaryOutcomes measure: Video of a sleeping sequence, secondaryOutcomes measure: Sleep cartoon for children, secondaryOutcomes measure: Kiddie-Sads-Present and Lifetime Version (K-SADS PL), secondaryOutcomes measure: Self efficacy dealing with social situations (WIRKSOZ), secondaryOutcomes measure: Group interviews, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: University Hospital Tuebingen, status: RECRUITING, city: Tuebingen, zip: 72076, country: Germany, contacts name: Annette Conzelmann, Prof. Dr., role: CONTACT, contacts name: Axel Franz, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Mirja Quante, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Andrea Bevot, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Anna Haigis, role: SUB_INVESTIGATOR, contacts name: Dorothee Fütterer, Dr., role: SUB_INVESTIGATOR, contacts name: Annette Conzelmann, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Tobias Renner, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False