RecruitingOBSERVATIONAL

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

Q: What is a 'preterm' infant?

A preterm infant is a baby born too early, specifically before 37 weeks of pregnancy. This study focuses on babies born very early, before 32 weeks, or weighing less than 1.5kg.

Q: Will my baby get extra medical care by joining this study?

No, your baby will receive the same high standard of medical care at the hospital whether you participate in the study or not. The study observes and collects information during routine care.

Q: What kind of 'samples' will be collected?

Biological samples, like blood or saliva, might be collected. This would primarily happen during times when blood tests are already routine for your baby's health needs, or with your specific permission.

Q: How long will my child be part of this study?

The study aims to follow children over several years, collecting information during their regular check-ups, potentially up to 18 years of age.

Q: What if I change my mind about participating?

You can withdraw your consent for your child to be part of the study at any time. This decision will not affect your child's medical care in any way.

The Neo-Life project is looking at babies born very early (before 32 weeks) or very small (under 1.5kg). Even though care for these babies has gotten much better, they can still face challenges with their health and development over time. This study wants to find out what factors, both from their body and their environment, help or hinder their development. We will collect health information and samples over several years to better understand how their organs develop and how they grow. This research aims to identify ways to give these babies the best start in life and improve their long-term health and well-being.

At a glance

Status

Recruiting

Sponsor

University Hospital of Cologne

Enrolment target

1,300

Start

13 Mar 2026

Estimated completion

13 Mar 2056

Preterm Infant Development Preterm Infant Health Prematurity Complications Premature Birth

What is this study about?

The Neo-Life project is a special study focused on understanding the health and development of babies born very prematurely. This means babies born before 32 weeks of pregnancy, or those who weighed less than 1500 grams (about 3 pounds 5 ounces) at birth. Doctors and nurses have made amazing progress in helping these tiny babies survive, but sometimes they can still face challenges with their health as they grow up. These challenges can affect different parts of their body, like their brain, lungs, heart, or kidneys, which might impact their quality of life.

The main idea behind Neo-Life is to carefully collect information about these babies' health and growth, along with some biological samples (like blood or saliva, for example). This will happen over several years, as part of their regular check-ups at the University Hospital Cologne. By doing this, we hope to discover what factors, both inside the baby's body and from their surroundings, act as a help or a hindrance to their development. For instance, we might find certain biological markers or specific care practices that lead to better outcomes.

The ultimate goal of this study is to use all this information to understand more about why some premature babies thrive and others face more difficulties. This knowledge could then help doctors and nurses develop new, more targeted ways to care for these babies. Our aim is to prevent or lessen health problems and ensure that every premature baby has the best possible chance to grow up healthy and strong.

Key takeaways

The Neo-Life study looks at premature babies born very early or very small.
It aims to understand what helps or hinders their development over time.
Information and samples are collected during regular hospital visits.
The goal is to improve future care and outcomes for premature infants.
Participation is voluntary and does not affect your baby's medical care.

Who may be eligible?

This study is open to babies born very early or very small. Specifically, babies who were born before 32 weeks of pregnancy, or who weighed less than 1500 grams (about 3 pounds 5 ounces) at birth, are eligible.

Participation in the study is completely voluntary and requires the parents or legal guardians to give their permission. If your baby fits these criteria and is receiving care at the University Hospital Cologne, you might be able to join. There are no specific reasons why a baby would not be able to take part in this study, other than the general birth criteria.

The study will follow your child from birth up to 18 years of age. This long-term approach helps us understand how being born prematurely affects a child's health and development over many years.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your baby born before 32 weeks of pregnancy?
Or, did your baby weigh less than 1500 grams (about 3 pounds 5 ounces) at birth?
Is your baby receiving care at the University Hospital Cologne?
Are you, as parents or legal guardians, willing to give permission for your child to participate?

Answer every question to see your result.

What does participation involve?

If your baby takes part in the Neo-Life study, it will mostly involve collecting information and samples during their regular hospital visits and check-ups at the University Hospital Cologne. This study aims to understand how very premature babies develop over several years. You won't be asked to do anything extra outside of the established follow-up care program for premature infants. This means no additional clinic visits specifically for the study, and no new medications or treatments. The study will track your child's health and development as they grow, including things like how they are feeding, their weight, and their overall progress. Biological samples, such as blood or saliva, may be collected when these are already needed for routine medical care, or with specific parental consent. This long-term tracking will continue for several years, usually up to the age of 5, but valuable data might be collected up to 18 years of age.

Potential risks and benefits

Participating in the Neo-Life study could help improve the understanding and care for other premature babies in the future, as the combined information will create a valuable resource for research. You will receive the standard high-quality care at the hospital, and participating will not change the medical care your baby receives. The risks are very low, as the study mainly involves collecting information during routine care and possibly some biological samples that might already be taken for medical reasons. Parents always have the right to withdraw their consent for their child to participate at any time, without it affecting their child's medical care.

Locations (1)

University Hospital Cologne
Verified postcode
Cologne, Germany· Recruiting

Common questions

What is a 'preterm' infant?

A preterm infant is a baby born too early, specifically before 37 weeks of pregnancy. This study focuses on babies born very early, before 32 weeks, or weighing less than 1.5kg.

Will my baby get extra medical care by joining this study?

No, your baby will receive the same high standard of medical care at the hospital whether you participate in the study or not. The study observes and collects information during routine care.

What kind of 'samples' will be collected?

Biological samples, like blood or saliva, might be collected. This would primarily happen during times when blood tests are already routine for your baby's health needs, or with your specific permission.

How long will my child be part of this study?

The study aims to follow children over several years, collecting information during their regular check-ups, potentially up to 18 years of age.

What if I change my mind about participating?

You can withdraw your consent for your child to be part of the study at any time. This decision will not affect your child's medical care in any way.

How to find out more

Charlotte S Schömig, Dr. med.

charlotte.schoemig@uk-koeln.de +49 221 478 85663 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.