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Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis

NCT06324500 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-03-22

No results posted yet for this study

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.

Conditions

  • Acute Severe Colitis

Sponsors & Collaborators

  • Meyer Children's Hospital IRCCS

    lead OTHER

Principal Investigators

  • Paolo Lionetti, MD · Meyer Children's Hospital IRCCS

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2025-03-02
Completion
2025-05-02

Countries

  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06324500 on ClinicalTrials.gov