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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00029193
Enrollment
200
Registered
2022-11-11
Start date
2022-12-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A41.9 K59.9

Interventions

Group 1: A longitudinal examination of the gut, tracheal, and pharyngeal microbiome in cardiac surgery patients who do not demonstrate septic complications perioperatively. Group 2: A longitudinal exa

Sponsors

Klinik für Anästhesiologie, Intensiv-, Notfall- und SchmerzmedizinUniversitätsklinikum Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0 Years to 12 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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? Can the microbiome analysis also provide a prognostic statement about the outcome of the patients? Can a correlation be shown between the results from the oral swabs, tracheal secretions, and stool samples?

Countries

Germany

Contacts

Public ContactKevin Tourelle

Klinik für Anästhesiologie, Intensiv-, Notfall- und SchmerzmedizinUniversitätsklinikum Heidelberg

kevin.tourelle@med.uni-heidelberg.de062215638193

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026