COMMUNITY: COdevelopment of Microbiota and imMUNITY in intensive care

Conditions: Microbiome Dysbiosis.
P36.9
P23.9
P37.9
Y95
T81.4
J95.9
T80.2
Bacterial sepsis of newborn, unspecified
Congenital pneumonia, unspecified

Registration Number: DRKS00034668

Lead Sponsor: Institut für Infektionsprävention für Krankenhaushygiene (Universitätsklinikum Freiburg)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 400

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

Missing declaration of consent.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Module A:<br>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.<br><br>Module B:<br>Explorative recording of the reciprocal influence of the parameters recorded in Module A on the neonatal microbiome.

Secondary Outcome Measures

Name	Time	Method
Module A:<br>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)<br>o Perinatal clinical, demographic and epidemiological parameters (e.g. pregnancy history, gestational age, antibiotic exposure, infections, devices, movement data) (package A1)<br>o Collection of data on hand hygiene (staff and parents in rooming-in) (package A2)<br>o Recording changes in the microbial load of the NICU over time (package A3)<br><br>Module B:<br>o Molecular genetic analysis of the native intestinal microbiome incl. probiotic strains (package B1)<br>o Immune cell populations (quantitative, temporal trajectories, intra- and inter-individual) (package B2)<br>o Psychological stress of the parents (stress/depression) (package B3)<br>o Recording of the 2-year outcome (infections, allergies, neurocognitive outcome) (package B4)<br>o Establishment of a biobank (package B5)