Actively Recruiting

Age: 0 - 18Years
All Genders
ID07490912

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

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • None

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

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

Loading map...

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

Similar Trials

A Randomized Control Trial of a Responsive Parenting Interve...

Premature Birth

Actively Recruiting

1 location

More Time More Milk - Wearable, Wireless Breast Pumps to Inc...

Premature Birth

Actively Recruiting

1 location

The Effects of Air Pollution on Pregnancy and Adverse Birth ...

Premature Birth

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here