P07.2
Conditions
Interventions
Group 1: Preterm and term neonates:
Comprehensive characterization of the innate and adaptive immune system and identification of novel parameters for assessing the overall health status of neonates
Sponsors
Perinatalzentrum Innenstadt Neonatologie im Dr. von Haunerschen Kinderspital LMU Klinikum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All preterm and full-term children for whom no exclusion criteria apply
Exclusion criteria
Exclusion criteria: Lack of consent, severe congenital malformations (e.g., complex cardiac defects), serious neurological disorders, confirmed genetic diseases/syndromes, metabolic defects, primary palliative care of the child.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the study is to identify novel parameters for assessing the overall health status of neonates and for the identification of at-risk patients. As this is an exploratory study, the primary objective is the establishment of a sufficiently large, stratified study cohort to enable robust subgroup analyses. Due to limited sample volumes, it is not possible to perform all components of the study program in parallel for all participants. Therefore, the inclusion of a broader cohort is planned in order to achieve an adequate number of cases per subgroup for the individual sub-analyses (e.g., transcriptomics, proteomics, functional in vitro assays). Study participants will be stratified into four groups according to gestational age: Extremely preterm infants: < 28+0 weeks of gestation Very preterm infants: 28+0–31+6 weeks of gestation Late preterm infants: 32+0–36+6 weeks of gestation Term-born infants: = 37+0 weeks of gestation To support interpretation and validation of the results, samples from healthy adult donors will additionally be included as reference controls. For each of these groups, the aim is to generate 5–10 complete datasets per sub-analysis. To achieve this, 50–100 infants per gestational age group will need to be recruited. The actual analyses will be performed in a modular manner, depending on sample availability and data quality. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Evaluation of multi-omics analyses from non-invasively collected biomaterials (e.g., saliva, urine) to assess their suitability for future longitudinal and alternative research approaches • Correlation of multi-omics data from blood samples with microbiome analyses from stool samples to investigate immune–microbiome interactions | — |
Countries
Germany
Contacts
Public ContactClaudia Nußbaum
Perinatalzentrum Innenstadt Neonatologie im Dr. von Haunerschen Kinderspital LMU Klinikum
Outcome results
None listed