The Oldenburg high-risk birth cohort: RisikO

Every year in Germany, over 60,000 children are born prematurely or with other risk factors. After a high-risk birth, there is an increased likelihood of developmental abnormalities in terms of acute and chronic complications. This particularly affects organs such as the brain and lungs.

A better understanding of the underlying mechanisms and the identification of risk markers is crucial in order to be able to assess developmental risks at an early stage and thus enable targeted therapies and long-term prevention strategies.

Why is the RisikO study important?

Developmental disorders after a high-risk birth can have lifelong effects. The optimal care or even prevention of high-risk births is one of the greatest challenges in perinatal medicine. Through interdisciplinary collaboration between neonatology, obstetrics, immunology, genetics, neuroscience, social sciences and bioinformatics, the RisikO study is helping to gain new insights. Only improved diagnostics and therapy can achieve personalised care and prevention of long-term complications in the context of high-risk births.

What is the aim of the RisikO study?

The aim of the high-risk birth study is to identify risk factors in the prenatal and early postnatal course and to understand their influence on organ development.

This includes

• the identification of immunological and (epi)genetic factors associated with pregnancy complications and at-risk birth, including molecular mechanisms that contribute to the development of brain and lung developmental disorders
• characterisation of patients and their environment using innovative imaging techniques, in particular magnetic resonance imaging (MRI)
• the description of the clinical and neuropsychological course and the characterisation of the psychosocial family environment
• data integration using modern analysis methods to comprehensively analyse large data sets from molecular, clinical and imaging examinations

How is the study organised?

The RisikO study includes children after a high-risk birth, e.g. after a premature or complicated birth, before birth or at the latest at birth. During the inpatient stay after birth, we will use biological samples (e.g. blood, smears, secretions, urine, stool) obtained from the child as part of the clinical routine in order to obtain information on relevant signalling factors using special examination techniques. As described above, this also includes immunological and genetic examinations of the material.
In order to better understand the measured characteristics, parental blood and placental tissue will also be examined.
For newborns at risk of altered brain or lung development, we will also offer imaging using high-resolution MRI in order to identify structural and functional changes.
All examinations as part of the RiskO study are non-invasive or carried out as part of routine clinical practice, so that no additional stress is placed on the newborns.
The protection of study-related data is a top priority. Therefore, all information collected as part of the study will be treated as strictly confidential, stored in pseudonymised form and used exclusively for scientific purposes. Written informed consent is an absolute prerequisite for participation.

We would like to thank our patients and their families, as well as all study partners, whose participation makes such an irreplaceably valuable contribution to the healthy development of at-risk newborns.

Your RisikO study team

If you would like to help improve the future of premature infant care or have any questions about the study or the process, please contact us here:

University Clinic for Paediatrics and Adolescent Medicine
Klinikum Oldenburg AöR
Rahel-Straus-Straße 10
26133 Oldenburg

Prof Dr Axel Heep (project leader)
Prof Dr Anne Hilgendorff (study director)

risiko-studie@uni-oldenburg.de

Partners of the RisikO study:

Department for Human Medicine, University of Oldenburg

- Prof. Dr med. Eduard Malik, University Clinic for Gynaecology and Obstetrics (study director)
- Prof. Dr rer. nat. Dr med. habil. Yulia Golub, University Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy (study director)
- Prof. Dr Marc-Phillip Hitz, University Institute of Medical Genetics
- Prof. Dr Martin Maurer, University Institute of Diagnostic and Interventional Radiology
- Prof. Dr Karin Loser, Institute of Immunology

Department of Psychology, University of Oldenburg

- Prof. Dr rer. nat. Andrea Hildebrandt, Psychological Methodology and Statistics

Department of Health Services Research, University of Oldenburg

- Prof. Dr rer. nat. Antje Wulff, Big Data in Medicine

University Medical Centre Groningen

- Prof Dr Torsten Plösch, UMC Groningen Experimental Perinatology

Research networks

- Transregional Collaborative Research Centre TRR 359 (PILOT; DFG)
- Project Intersectoral Care for Vulnerable Groups (INGVER; BMFTR)