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

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.

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 Overview

• Status: Recruiting
• Conditions: Premature Birth; Preterm Infant Development; Preterm Infant Health; Prematurity Complications

• Study Type: Observational
• Enrollment (Estimated): 1300

Contacts and Locations

• Study Contact: Name: Charlotte S Schömig, Dr. med.; Phone Number: +49 221 478 85663; Email: charlotte.schoemig@uk-koeln.de
• Study Contact Backup: Name: Angela Kribs, Apl. Prof. Dr.; Phone Number: +49 221 478 85663; Email: angela.kribs@uk-koeln.de

Study Locations

• Germany
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Recruiting
      • University Hospital Cologne
      • Contact: Charlotte S Schömig, Dr. med.; Phone Number: +49 221 478 85663; Email: charlotte.schoemig@uk-koeln.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival without cognitive impairment	Neurocognitive Impairment is defined as Bayley Scales of Infant Development III (Bayley - III) cognitive score less than 84.	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.	at the age of 5 years
Survival without visual impairment	Visual impairment is defined as need of visual aid or blindness.	at the age of 5 years
Survival without hearing impairment	Hearing impairment is defined as hearing with amplification or hearing loss despite amplification.	at the age of 5 years
Survival without seizures	The occurrence of seizures is assessed during follow-up visits.	at the age of 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of breast feeding	Duration of breast feeding is assessed during follow-up visits.	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.	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.	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.	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.	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.	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.	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.	at the corrected age of 35-40 weeks' gestational age and at the corrected age of 24 months

Collaborators and Investigators

• Sponsor: University Hospital of Cologne
• Investigators: Principal Investigator: Angela Kribs, Apl. Prof. Dr., University Hospital Cologne; Principal Investigator: Miguel A Alejandre Alcázar, Prof. Dr., University Hospital Cologne

Study record dates

Study Major Dates

• Study Start (Estimated): March 13, 2026
• Primary Completion (Estimated): March 13, 2036
• Study Completion (Estimated): March 13, 2056

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: preterm infants; biobank; prematurity; Premature birth; very low birth weight infants; database; very low birth weight; very preterm infants; gestational age <32 weeks; <32 weeks gestational age; <1500 g birth weight; preterm infant development; preterm infant health; preterm infant long-term outcome; prematurity complications; risk and protective factors of preterm infant development
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 23-1226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No