Neonatal data and biobank to understand what influences development in very preterm infants
Establishing a Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/or <1500 g Birth Weight
This project will collect clinical information and biological samples to see if early biological, clinical, and environmental factors predict short- and long-term development in infants born before 32 weeks or under 1500 g.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1300 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | University Hospital of Cologne Academic / other |
| Locations | 1 site (Cologne, North Rhine-Westphalia) |
| Trial ID | NCT07490912 on ClinicalTrials.gov |
What this trial studies
The Neo-Life project prospectively collects standardized clinical data and biological samples from very preterm infants (born <32 weeks gestation and/or <1500 g) at the University Hospital Cologne. Participants enter an interdisciplinary follow-up program with structured timepoints for clinical assessments and biosample collection to monitor neurological, pulmonary, cardiovascular, renal, and other outcomes. Researchers will link biological markers with clinical and environmental data to identify early risk and protective factors for later development. The resulting dataset and biobank are intended to support future research and the design of targeted interventions to reduce long-term morbidity.
Who should consider this trial
Good fit: Ideal candidates are infants born before 32 weeks' gestation and/or with birth weight below 1500 g whose parents or legal guardians provide informed consent.
Not a fit: Infants born at term or above the gestational age/weight thresholds, or those without parental consent, are not eligible and would not receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the biobank could reveal early markers and modifiable factors that enable earlier, more targeted care to improve long-term outcomes for very preterm infants.
How similar studies have performed: Similar neonatal cohorts and biobanks have identified clinical and biological factors linked to outcomes in preterm infants, although turning these findings into broadly effective treatments is still an ongoing process.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm infants born \<32 weeks' gestational age and/or with a birth weight \< 1500 g * Informed consent of parents/ legal guardians Exclusion Criteria: * none
Where this trial is running
Cologne, North Rhine-Westphalia
- University Hospital Cologne — Cologne, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Angela Kribs, Apl. Prof. Dr. — University Hospital Cologne
- Study coordinator: Charlotte S Schömig, Dr. med.
- Email: charlotte.schoemig@uk-koeln.de
- Phone: +49 221 478 85663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.