Risk births
Conditions
Interventions
Group 1: Premature infants with a gestational age of 23+0 to 36+6 weeks and full-term newborns with a gestational age of 37+0 to 40+0 weeks with pregnancy- or birth-related risk factors are prospectiv
Sponsors
Carl von Ossietzky Universität Oldenburg - Fakultät VI - Medizin und Gesundheitswissenschaften
Eligibility
Sex/Gender
All
Age
No minimum to 60 Months
Inclusion criteria
Inclusion criteria: Children between 0 and 6 years of age after premature birth with a gestational age of 23+0 to 36+6 weeks of pregnancy and full-term babies with a gestational age of 37+0 to 40+0 weeks of pregnancy with pregnancy or birth-related risk factors, whose parents consent to scientific research upon discharge from the hospital.
Exclusion criteria
Exclusion criteria: Severe congenital anomalies diagnosed prenatally or postnatally with cardiopulmonary dysfunction that are incompatible with medium-term survival. Presence of diaphragmatic hernia or confirmed trisomy 13 or 18. Metabolic defects that result in impairment of the entire organism. Palliative treatment goal determined within the first 10 minutes of life postpartum; subsequent changes to the treatment goal are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is the molecular biological, immunological, and genetic characterization of the biological samples obtained after discharge from the hospital until the age of five in order to identify risk markers for better early detection and/or to develop more targeted therapeutic strategies for children born at risk. The child's developmental status, the psychosocial environment of the child and parents, and parent-child interactions are also recorded using questionnaires. Data collection ends 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 and the end date of the study will be recorded by the UOL trust agency, which monitors the consent and pseudonymization of participants. | — |
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