Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324500
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-02-23
Brief Title:
Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis
Sponsor:
Meyer Childrens Hospital IRCCS
Organization:
Meyer Childrens Hospital IRCCS
Study Overview
Official Title:
Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis ASC A Prospective Multicenter Study From the Paediatric IBD Porto Group of ESPGHAN
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None