Preterm Infant DevelopmentNeo-LifeNCT07490912
Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/or <1500 g Birth Weight
An observational study of Preterm Infant Development and Preterm Infant Health, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants. Advances in neonatal care have significantly improved survival rates of infants born with a gestational age of less than 32 weeks and/or a… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Preterm Infant Development, Preterm Infant Health, Prematurity Complications
- How many people
- 1,300 participants
- Where
- 1 siteGermany
- Study dates
- 13 Mar 2026to 13 Mar 2056
- How long will I take part?
- 18 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Infants born with a gestational age of less than 32 weeks and/or a birth weight below 1500 g who receive care at the perinatal center of the University Hospital Cologne
Who may be able to join
- Preterm infants born <32 weeks' gestational age and/or with a birth weight < 1500 g
- Informed consent of parents/ legal guardians
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
Charlotte S Schömig, Dr. med., +49 221 478 85663, charlotte.schoemig@uk-koeln.de
About this study
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
The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants. Advances in neonatal care have significantly improved survival rates of infants born with a gestational age of less than 32 weeks and/or a birth weight below 1500 g. However, these infants remain at high risk for multiple complications affecting neurological, pulmonary, cardiovascular, renal, and other organ systems, which may lead to long-term morbidity and reduced quality of life. Identifying early risk and protective factors is therefore essential to improve outcomes and develop targeted interventions.
The primary objective of the project is the prospective and structured collection of clinical data as well as biological samples within a standardized interdisciplinary follow-up program for preterm infants. The study aims to identify biological, clinical, and environmental factors associated with the development and long-term outcomes of different organ systems.
Read more
The study population includes infants born with a gestational age of less than 32 weeks and/or a birth weight below 1500 g who receive care at the perinatal center of the University Hospital Cologne. Participation requires informed consent from the parents or legal guardians. There are no specific exclusion criteria. Participants will be followed within the established preterm follow-up program over several years, allowing longitudinal assessment of clinical outcomes and developmental trajectories. Primary outcome is survival without impairment (e.g. neurocognitive, pulmonal, cardiovascular, renal) at the age of 5 years. Secondary outcomes include duration of breastfeeding, nutritional status, body mass index, and parental stress and bonding. In addition, biological samples will be collected to enable the creation of epigenetic, gene expression, and cytokine profiles. These data will contribute to the identification of predictive biomarkers that may help stratify risk and guide individualized preventive or therapeutic strategies in preterm infants.
By combining comprehensive clinical data with biological samples in a dedicated data and biobank, the Neo-Life project aims to generate a valuable resource for translational research. The findings are expected to improve understanding of the mechanisms underlying organ development and long-term health in preterm infants and to support the development of early interventions that may prevent or mitigate adverse outcomes.
- Conditions
- Preterm Infant Development, Preterm Infant Health, Prematurity Complications, Premature Birth
- Keywords
- prematurity, preterm infants, very low birth weight infants, very preterm infants, gestational age <32 weeks, Premature birth, <32 weeks gestational age, very low birth weight, <1500 g birth weight, database, biobank, preterm infant development, preterm infant health, preterm infant long-term outcome, prematurity complications, risk and protective factors of preterm infant development
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants <32 weeks' GA and/or <1500 BW | Preterm infants born <32 weeks' gestational age and/or with a birth weight <1500 g who receive care at the perinatal center of the University Hospital Cologne. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without cognitive impairment
Neurocognitive Impairment is defined as Bayley Scales of Infant Development III (Bayley - III) cognitive score less than 84.
Measured: at the age of 5 years
Survival without impaired motor function
Motor function impairment is defined as Gross Motor Function Classification System (GMFCS) level of 2 or higher.
Measured: at the age of 5 years
Survival without visual impairment
Visual impairment is defined as need of visual aid or blindness.
Measured: at the age of 5 years
Survival without hearing impairment
Hearing impairment is defined as hearing with amplification or hearing loss despite amplification.
Measured: at the age of 5 years
Survival without seizures
The occurrence of seizures is assessed during follow-up visits.
Measured: at the age of 5 years
Secondary outcomes (8)
Duration of breast feeding
Duration of breast feeding is assessed during follow-up visits.
Measured: 2 years
Weight gain
Weight progression is assessed using percentile curves (Fenton, WHO). This includes assessing wether the weight trajectory lies within the normal range (10th - 90th percentile) and wether percentile shifts occur.
Measured: birth to the age of 18 years
Growth in length/height
Growth in length/height is assessed using percentile curves (Fenton, WHO). This includes assessing wether the length/height trajectory lies within the normal range (10th - 90th percentile) and wether percentile shifts occur.
Measured: birth to the age of 18 years
General Movements
Early infant development will be assessed using General Movements Assessment by Prechtl. It is a validated diagnostic tool for the functional assessment of the young nervous system.
Measured: corrected 3 months of age
Maternal depression
The German long form of the Center for Epidemiological Studies Depression Scale (CES-D) will be used to assess maternal depression. The self-report questionnaire consists of 20 questions and its score ranges from 0 to 60. A score of 15 or higher indicates a risk of depression.
Measured: at the corrected age of 35-40 weeks' gestational age, at the corrected age of 6 months and at the corrected age of 24 months
Post-traumatic Stress
Post-traumatic stress is assessed with the impact of event scale - revised (IES-R). The self-report questionnaire consists of 22 questions and includes 3 sub-scales (intrusion, avoidance and hyperarousal). The overall score ranges from -4,36 to 2,99. A result above 0 is interpreted to indicate a risk of post-traumatic stress disorder.
Measured: at the corrected age of 6 months
Parental Bonding
Parental Bonding is assessed using the parental bonding questionnaire (PBQ), which consists of 25 items and includes 4 sub-scales (impaired bonding, rejection and anger, anxiety about care, risk of abuse). A higher the score indicates a higher risk of a disorder in each area of the sub-scale.
Measured: corrected age of 6 and 24 months
Social Support
Social support is assessed using the short version of the German questionnaire for social support (Fragebogen zur sozialen Unterstützung, questionnaire on social support) scale (F-SozU K-22). The questionnaire includes 22 items and its scale ranges from a minimum of 22 points to a maximum of 110 points. The higher the score, the better the subjectively perceived or anticipated support.
Measured: at the corrected age of 35-40 weeks' gestational age and at the corrected age of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start13 Mar 2026 (estimated)
- Primary completion13 Mar 2036 (estimated)
- Study completion13 Mar 2056 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Sophie Schömig, University Hospital of Cologne
- Investigators
- Angela Kribs, Apl. Prof. Dr., Principal investigator, University Hospital of CologneMiguel A Alejandre Alcázar, Prof. Dr., Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490912
- Sponsor's protocol ID
- 23-1226
- Acronym
- Neo-Life
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the participants in this study are minors, special attention will be paid to the protection of personal data. Therefore, the information and consent documents provided to the legal guardians contain a statement assuring that no data will be disclosed to third parties.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07490912
- Acronym / sponsor ID
- Neo-Life / 23-1226
- Conditions
- Preterm Infant Development, Preterm Infant Health, Prematurity Complications, Premature Birth
- Keywords
- prematurity, preterm infants, very low birth weight infants, very preterm infants, gestational age <32 weeks, Premature birth, <32 weeks gestational age, very low birth weight
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 13 Mar 2026 (estimated)
- Primary completion
- 13 Mar 2036 (estimated)
- Study completion
- 13 Mar 2056 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants. Advances in neonatal care have significantly improved survival rates of infants born with a gestational age of less than 32 weeks and/or a birth weight below 1500 g. However, these infants remain at high risk for multiple complications affecting neurological, pulmonary, cardiovascular, renal, and other organ systems, which may lead to long-term morbidity and reduced quality of life. Identifying early risk and protective factors is therefore essential to improve outcomes and develop targeted interventions.
The primary objective of the project is the prospective and structured collection of clinical data as well as biological samples within a standardized interdisciplinary follow-up program for preterm infants. The study aims to identify biological, clinical, and environmental factors associated with the development and long-term outcomes of different organ systems.
The study population includes infants born with a gestational age of less than 32 weeks and/or a birth weight below 1500 g who receive care at the perinatal center of the University Hospital Cologne. Participation requires informed consent from the parents or legal guardians. There are no specific exclusion criteria. Participants will be followed within the established preterm follow-up program over several years, allowing longitudinal assessment of clinical outcomes and developmental trajectories. Primary outcome is survival without impairment (e.g. neurocognitive, pulmonal, cardiovascular, renal) at the age of 5 years. Secondary outcomes include duration of breastfeeding, nutritional status, body mass index, and parental stress and bonding. In addition, biological samples will be collected to enable the creation of epigenetic, gene expression, and cytokine profiles. These data will contribute to the identification of predictive biomarkers that may help stratify risk and guide individualized preventive or therapeutic strategies in preterm infants.
By combining comprehensive clinical data with biological samples in a dedicated data and biobank, the Neo-Life project aims to generate a valuable resource for translational research. The findings are expected to improve understanding of the mechanisms underlying organ development and long-term health in preterm infants and to support the development of early interventions that may prevent or mitigate adverse outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants <32 weeks' GA and/or <1500 BW | – | –Preterm infants born <32 weeks' gestational age and/or with a birth weight <1500 g who receive care at the perinatal center of the University Hospital Cologne. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Infants born with a gestational age of less than 32 weeks and/or a birth weight below 1500 g who receive care at the perinatal center of the University Hospital Cologne
Key inclusion criteria (2 listed)
- Preterm infants born <32 weeks' gestational age and/or with a birth weight < 1500 g
- Informed consent of parents/ legal guardians
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival without cognitive impairment
Time frame: at the age of 5 years
Neurocognitive Impairment is defined as Bayley Scales of Infant Development III (Bayley - III) cognitive score less than 84.
Survival without impaired motor function
Time frame: at the age of 5 years
Motor function impairment is defined as Gross Motor Function Classification System (GMFCS) level of 2 or higher.
Survival without visual impairment
Time frame: at the age of 5 years
Visual impairment is defined as need of visual aid or blindness.
Survival without hearing impairment
Time frame: at the age of 5 years
Hearing impairment is defined as hearing with amplification or hearing loss despite amplification.
Survival without seizures
Time frame: at the age of 5 years
The occurrence of seizures is assessed during follow-up visits.
8 secondary outcomes
Duration of breast feeding
Time frame: 2 years
Weight gain
Time frame: birth to the age of 18 years
Growth in length/height
Time frame: birth to the age of 18 years
General Movements
Time frame: corrected 3 months of age
Maternal depression
Time frame: at the corrected age of 35-40 weeks' gestational age, at the corrected age of 6 months and at the corrected age of 24 months
Post-traumatic Stress
Time frame: at the corrected age of 6 months
Parental Bonding
Time frame: corrected age of 6 and 24 months
Social Support
Time frame: at the corrected age of 35-40 weeks' gestational age and at the corrected age of 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No. As the participants in this study are minors, special attention will be paid to the protection of personal data. Therefore, the information and consent documents provided to the legal guardians contain a statement assuring that no data will be disclosed to third parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Kribs, Apl. Prof. Dr. principal investigator
University Hospital of Cologne
Miguel A Alejandre Alcázar, Prof. Dr. principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infant Development and Preterm Infant Health, run by University Hospital of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte S Schömig, Dr. med. (+49 221 478 85663, charlotte.schoemig@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without cognitive impairment (time frame: at the age of 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.