protocolSection identificationModule nctId: NCT06324500, orgStudyIdInfo id: ASC-US, briefTitle: Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-03-02, primaryCompletionDateStruct date: 2025-03-02, completionDateStruct date: 2025-05-02, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: ASC is a life-threatening medical emergency. The lack of a timely intervention has shown to be associated with a mortality rate higher than 20% in adults, whereas a prompt targeted therapy has displayed a decrease of the aforementioned rate to 1%. Therefore, the identification of predictors of poor outcome trough an objective tool may provide crucial help to individualize the timing of second line treatment initiation. At the state of the art, PUCAI represents the only validated tool to appraise the risk of first-line treatment failure and there is a lack of objective methods with a prognostic value in ASC.BUS has proven to be a reliable tool in assessing disease activity in children with UC and it has also shown statistically significant correlation with endoscopic features of disease activity. Given the literature suggesting a role for BUS in severe UC and the results from our retrospective study we aim to validate our findings trough a prospective assessment of the potential prognostic role of BUS in ASC., conditionsModule conditions: Acute Severe Colitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, outcomesModule primaryOutcomes measure: Colonic wall thickness of BUS (bowel ultrasound) parameter to predict the failure of first line treatment, primaryOutcomes measure: Color and power Doppler vascularization of BUS (bowel ultrasound) parameter to predict the failure of first line treatment, primaryOutcomes measure: Mesenteric lymph nodes BUS (bowel ultrasound) parameter, secondaryOutcomes measure: evaluation of the prognostic value of the ultrasound parameters, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, state: Firenze, zip: 50139, country: Italy, contacts name: Paolo Lionetti, role: CONTACT, email: paolo.lionetti@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Maggiore, status: RECRUITING, city: Bologna, country: Italy, contacts name: Patrizia Alvisi, role: CONTACT, email: Patrizia.alvisi@ausl.bologna.it, geoPoint lat: 44.49381, lon: 11.33875, locations facility: IRCCS Materno Infantile Burlo Garofolo, status: RECRUITING, city: Trieste, country: Italy, contacts name: Matteo Bramuzzo, role: CONTACT, email: matteo.bramuzzo@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, locations facility: CMED Centro Médico-Quirúrgico de Enfermedades Digestivas, status: RECRUITING, city: Madrid, country: Spain, contacts name: Marta Velasco Rodriguez- Belvis, role: CONTACT, email: martavrb@gmail.com, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False