Clinical Research Directory

Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/or <1500 g Birth Weight

The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants. Advances in neonatal care have significantly improved survival rates of infants born with a gestational age of less than 32 weeks and/or a birth weight below 1500 g. However, these infants remain at high risk for multiple complications affecting neurological, pulmonary, cardiovascular, renal, and other organ systems, which may lead to long-term morbidity and reduced quality of life. Identifying early risk and protective factors is therefore essential to improve outcomes and develop targeted interventions. The primary objective of the project is the prospective and structured collection of clinical data as well as biological samples within a standardized interdisciplinary follow-up program for preterm infants. The study aims to identify biological, clinical, and environmental factors associated with the development and long-term outcomes of different organ systems. The study population includes infants born with a gestational age of less than 32 weeks and/or a birth weight below 1500 g who receive care at the perinatal center of the University Hospital Cologne. Participation requires informed consent from the parents or legal guardians. There are no specific exclusion criteria. Participants will be followed within the established preterm follow-up program over several years, allowing longitudinal assessment of clinical outcomes and developmental trajectories. Primary outcome is survival without impairment (e.g. neurocognitive, pulmonal, cardiovascular, renal) at the age of 5 years. Secondary outcomes include duration of breastfeeding, nutritional status, body mass index, and parental stress and bonding. In addition, biological samples will be collected to enable the creation of epigenetic, gene expression, and cytokine profiles. These data will contribute to the identification of predictive biomarkers that may help stratify risk and guide individualized preventive or therapeutic strategies in preterm infants. By combining comprehensive clinical data with biological samples in a dedicated data and biobank, the Neo-Life project aims to generate a valuable resource for translational research. The findings are expected to improve understanding of the mechanisms underlying organ development and long-term health in preterm infants and to support the development of early interventions that may prevent or mitigate adverse outcomes.

PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants

The goal of this clinical trial is to understand the impact of respiratory microbiome maturation in respiratory health of preterm infants under 32 gestational weeks. The main questions it aims to answer are: * What is the role of microbiome maturation in respiratory health (development of bronchopulmonary dysplasia, childhood asthma and viral respiratory infections) of preterm infants ? * Which environmental or health factors are involved in the maturation of the respiratory microbiome ? Participants will undergo follow-up from birth until 3 years of corrected age including nasal swabs, stool samples, and for some of them blood and milk sample.

Pilot Study: Effects of CCP Intervention on NICU Environment and Preterm Infants Development

Close Collaboration with Parents intervention is an evidence-based educational intervention for the entire multi-professional staff of neonatal intensive care units (NICUs). The goal of the intervention is to strengthen partnership between staff and parents, enhance parental participation in infant care. There are no studies yet about the effects of the Close Collaboration with Parents intervention on the long-term neurodevelopment and socio-emotional development of very preterm infants and their interaction with their parents. Accordingly, a multicenter cluster randomized controlled trial is planned. Prior to initiating this large-scale study, it is essential to validate the measurement instruments. Therefore, a pilot study will be conducted to assess their feasibility and to determine the appropriate sample size.