Clinical trial Recruiting at 1 site Observational Ages Any age to 18

Neonatal data and biobank to understand what influences development in very preterm infants

Official title: 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

Run by University Hospital of Cologne · NCT07490912 · Data updated 2026-11-12

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 typeObservational
AgesAny age to 18 Years
SexAll
Enrollment1300 (estimated)
SponsorUniversity Hospital of Cologne
Academic / other
Locations1 site (Cologne, North Rhine-Westphalia)
StatusRecruiting
StartedMarch 13, 2026
Main results expectedMarch 13, 2036
Study endsMarch 13, 2056
Registry record updatedMarch 24, 2026
Trial IDNCT07490912 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University Hospital Cologne
    Cologne, North Rhine-Westphalia, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.