Microbiome Dysbiosis. P36.9 P23.9 P37.9 Y95 T81.4 J95.9 T80.2
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Institut für Infektionsprävention für Krankenhaushygiene (Universitätsklinikum Freiburg)