Actively Recruiting
Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born Before 32 Weeks' Gestation and/or Under 1500 g Birth Weight
Led by University Hospital of Cologne · Updated on 2026-03-24
1300
Participants Needed
1
Research Sites
1043 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating factors that influence the development and long-term health outcomes of very preterm infants born before 32 weeks of gestation and/or with a birth weight under 1500 grams. The study aims to understand risks and protective factors affecting multiple organ systems such as neurological, pulmonary, cardiovascular, and renal systems. It also seeks to improve knowledge about survival and quality of life for these infants through a comprehensive, prospective data collection and biobank. The study involves collecting detailed clinical information and biological samples from preterm infants receiving care at the University Hospital Cologne's perinatal center. Participants are followed within a standardized, interdisciplinary program that monitors their development over several years. This approach allows for the collection of data on growth, neurocognitive function, and other health outcomes, alongside biological markers like gene expression and cytokine profiles. Parents or legal guardians provide consent for participation, and infants are tracked through routine follow-up visits that assess survival without impairments in cognition, motor skills, vision, hearing, or seizures up to five years of age. Secondary outcomes include breastfeeding duration, growth measurements, maternal mental health, parental bonding, and social support. This long-term observation aims to identify biomarkers and clinical factors to better predict risks and guide future preventive or therapeutic care for preterm infants.
CONDITIONS
Brief Title
Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/or <1500 g Birth Weight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants born before 32 weeks' gestational age and/or with a birth weight below 1500 grams
- Informed consent given by parents or legal guardians
You will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 years
Participants are observed over a long period to study development and outcomes such as survival without cognitive, motor, visual, hearing impairments, and seizures.
Multiple assessments over 18 years including visits at corrected ages of 3 months, 6 months, 24 months, and up to 18 years
Trial Site Locations
Total: 1 location
1
University Hospital Cologne
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
Research Team
C
Charlotte S Schömig, Dr. med.
A
Angela Kribs, Apl. Prof. Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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