Risk births
Conditions
Interventions
Group 1: Premature infants with a gestational age of 23+0 to 36+6 weeks of pregnancy and full-term infants with a gestational age of 37+0 to 40+0 weeks of pregnancy with pregnancy- or birth-related ri
Sponsors
Carl von Ossietzky Universität Oldenburg - Fakultät VI - Medizin und Gesundheitswissenschaften
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Premature babies with a gestational age of 23+0 to 36+6 weeks of pregnancy and full-term newborns with a gestational age of 37+0 to 40+0 weeks of pregnancy with pregnancyor birth-related risk factors who are born at the Perinatal Center at Oldenburg Hospital AöR and whose parents consent to the scientific research.
Exclusion criteria
Exclusion criteria: Prenatal or postnatal diagnosed severe congenital anomalies with cardiopulmonary dysfunction that are incompatible with mid-term survival. Congenital diaphragmatic hernia or reliable trisomy 13 and 18. Metabolic defects, that lead to severe compromise for the organism. Palliativ treatment decided in the first 10 minutes of life postpartum, later change of therapeutic objective hereof excepted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is the molecular biological, immunological and genetic characterization of the biosamples obtained from high-risk births up to hospital discharge in order to identify risk markers for better early detection and/or the development of more targeted therapeutic strategies for premature babies. Data collection will end once a case number of n=500 (main group, premature infants) and n=200 (reference group, full-term infants after high-risk birth) children has been reached. The study will end 10 years after the last patient has been included in the study in order to allow for all necessary analyses and evaluations. The number of participants is recorded by the Treuhandstelle UOL , which monitors the consent and pseudonymization of participants. Planned evaluations and analyses: To characterize the transcriptome and proteome, cell biological surface markers (CD3, CD4, CD8, CD11a/b, CD14, CD15, CD16, CD18, CD19, CD27, CD45, CD54, CD56, NKp44, NKp46) are examined using flow cytometry and the cells are differentiated into neutrophils, monocytes/macrophages, B lymphocytes, T4/T8 lymphocytes, NK cells. If necessary, further surface markers that are identified as potentially relevant for this study cohort during the course of the study will be included. Certain cells may be propagated under cell culture conditions and, depending on the data available, stimulated with 1) individual regulated cytokines or a combination of these and the effect on e.g. proliferation, differentiation and apoptosis is determined 2)Cell lines of the hematopoietic cell fraction of interest and primary cells of the tracheal secretion co-incubated before and after stimulation/differentiation (evaluation see 1) Molecular supernatants, tissue and cell fractions are examined to analyze the transcriptome, metabolome and proteome. For this purpose, common PCR methods, microarray analyses, common GC/LC-MS protocols and focused analyses of proteins, e.g. growth factors, members of the dea | — |
Secondary
| Measure | Time frame |
|---|---|
| Further cDNA libraries are to be created through single-cell analysis. This will be followed by bioinformatic processing of the raw data in order to obtain counting matrices for the isolated nuclei. Based on the harmonized object, the signaling pathways of immune development in the first days of life will be traced. To identify regulatory networks, a selection of genes controlling the maturation of the immune system in clinically normal newborns without lung disease will be generated. The prioritization of transcription factors crucial for physiological immune cell differentiation is performed using the SCENIC algorithm (Aibar et al., 2017). | — |
Countries
Germany
Contacts
Public ContactAnne Hilgendorff
Carl von Ossietzky Universität Oldenburg - Fakultät VI - Universitätsklinik für Kinder- und Jugendmedizin, Klinikum Oldenburg AöR
Outcome results
None listed