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COMMUNITY: COdevelopment of Microbiota and imMUNITY in intensive care

COMMUNITY: COdevelopment of Microbiota and imMUNITY in intensive care - COMMUNITY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00034668
Enrollment
400
Registered
2024-07-17
Start date
2025-03-01
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

Microbiome Dysbiosis. P36.9 P23.9 P37.9 Y95 T81.4 J95.9 T80.2

Interventions

Group 1: Explorative module A: All patients of the neonatal intensive care unit (NICU) of the University Medical Center Freiburg before relocation and after relocation of the NICU to a new building un

Sponsors

Institut für Infektionsprävention für Krankenhaushygiene (Universitätsklinikum Freiburg)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 28 Days

Inclusion criteria

Inclusion criteria: Module A: All admitted patients in the defined study period. Module B: For Module B, all premature infants under 32 weeks gestational age are included. In addition, newborns/preterm infants with a higher gestational age are included if an inpatient treatment period of at least 7 days has been reached. In addition, any parents who may have been admitted are also included (Rooming-In-Setting).

Exclusion criteria

Exclusion criteria: Missing declaration of consent.

Design outcomes

Primary

MeasureTime frame
Module A: Colonization rate of patients (and possibly parents in rooming-in) with potentially pathogenic bacteria ("KRINKO pathogen-plus") in comparison between new and old intensive care unit. Module B: Explorative recording of the reciprocal influence of the parameters recorded in Module A on the neonatal microbiome.

Secondary

MeasureTime frame
Module A: o Frequency of transmission chains in comparison between old and new neonatal intensive care unit; separate consideration for patients with and without rooming-in (package A1) o Perinatal clinical, demographic and epidemiological parameters (e.g. pregnancy history, gestational age, antibiotic exposure, infections, devices, movement data) (package A1) o Collection of data on hand hygiene (staff and parents in rooming-in) (package A2) o Recording changes in the microbial load of the NICU over time (package A3) Module B: o Molecular genetic analysis of the native intestinal microbiome incl. probiotic strains (package B1) o Immune cell populations (quantitative, temporal trajectories, intra- and inter-individual) (package B2) o Psychological stress of the parents (stress/depression) (package B3) o Recording of the 2-year outcome (infections, allergies, neurocognitive outcome) (package B4) o Establishment of a biobank (package B5)

Countries

Germany

Contacts

Public ContactKim-Minh Quoc-Trung Timmy

Institut für Infektionsprävention für Krankenhaushygiene (Universitätsklinikum Freiburg)

timmy.nguyen@uniklinik-freiburg.de+4976127082630

Outcome results

None listed

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