MIcrobiotic analysis in Children undergoing Heart surgery after Antibiotic Application - Trial

• Conditions: A41.9; K59.9; Sepsis, unspecified; Functional intestinal disorder, unspecified

• Registration Number: DRKS00029193
• Lead Sponsor: Klinik für Anästhesiologie, Intensiv-, Notfall- und SchmerzmedizinUniversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Written informed consent by the legal guardians of the study participant
- Newborn age up to and including 12 years

Exclusion Criteria

- Refusal of participation in the study by legal representatives
- Age >12 years
- Pregnancy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Does the enteric microbiome return to baseline (residence) after 12 months at the latest and thus recover from initial antibiotic therapy?

Secondary Outcome Measures

Name	Time	Method
Is there a change in the enteric microbiome due to the administration of antibiotics in children and youths who had not previously received antibiotic therapy?<br><br>Can the microbiome analysis also provide a prognostic statement about the outcome of the patients?<br><br>Can a correlation be shown between the results from the oral swabs, tracheal secretions, and stool samples?