P22.0
Conditions
Interventions
Group 1: Main Observation Group: Very preterm infants (VLBW infants) born at = 32+0 weeks of gestation at the Perinatal Center Ulm. This group is observed throughout their entire stay in the neonatal
Sponsors
Universitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Gestational Age: All very preterm infants (VLBW infants) born at = 32+0 weeks of gestation at the Perinatal Center Ulm. - Healthy Term-Born Newborns: Newborns who are healthy and born at term. - Pregnant Women with Intact Pregnancies: Pregnant women undergoing amniocentesis or fetal interventions.
Exclusion criteria
Exclusion criteria: - Severe congenital malformations: According to international classification systems, excluding inguinal hernias, PDA, atrial septal defects, ventricular septal defects, and all congenital anomalies that do not affect pulmonary, cardiovascular, and psychomotor capacities. - Severe genetic disorders: Excluding genetic disorders that are not relevant to pulmonary, cardiovascular, and psychomotor outcomes. - Severe metabolic diseases: Excluding hyperglycemia of the preterm infant. - Birth before 22+0 weeks of gestation. - Palliative care decision: Before inclusion in the study. - No parental consent. - Withdrawal of consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the Ulm BPD study is the connection of pulmonary outcome categories, specified by the severity of Bronchopulmonary Dysplasia (BPD), to differences in the epigenetic, microbial, immuno-metabolic, and clinical phenotype? | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes include detailed associations of patient characteristics with comprehensive biosample analyses. These analyses particularly focus on: - The immune system metabolism. - Epigenetic profiling. - Growth factor signaling. - Urine metabolomics. - Tracheal aspirate collections, reflecting the situation in the immature lung during mechanical ventilation and oxygen exposure. - Microbial samples at birth and during the longitudinal course in the NICU to study the impact of specific microbiota structures and microbial axes. The study also aims to establish a comprehensive view of the disease origins by analyzing the interactions between different baseline risks, clinical management, and biosample analyses concerning the pulmonary outcome (BPD) in very preterm infants | — |
Countries
Germany
Contacts
Public ContactHarald Ehrhardt
Universitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin
Outcome results
None listed