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

NCT07490912 | Recruiting

• 1 other identifier: 23-1226
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Duration of breast feeding

  2 years

• Weight gain

  birth to the age of 18 years

• Growth in length/height

  birth to the age of 18 years

• General Movements

  corrected 3 months of age

• Maternal 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

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Preterm infants born \<32 weeks' gestational age and/or with a birth weight \< 1500 g
• Informed consent of parents/ legal guardians

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital of Cologne: lead

Study Sites (1)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* amniotic fluid (when opening the amniotic sac at birth) * umbilical cord * umbilical cord blood * urine (collection two times during the postnatal hospital stay) * breast milk (freshly pumped, collection two times during the postnatal hospital stay) * blood (in the context of clinical routine blood draws) * cerebrospinal fluid (if excess material from clinically indicated analyses available) * stool * buccal mucosa (collection via swab before discharge as well as during follow-up)

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Angela Kribs, Apl. Prof. Dr.

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

• Miguel A Alejandre Alcázar, Prof. Dr.

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte S Schömig, Dr. med.

CONTACT

+49 221 478 85663; charlotte.schoemig@uk-koeln.de

Angela Kribs, Apl. Prof. Dr.

CONTACT

+49 221 478 85663; angela.kribs@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 24, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): March 13, 2036
• Study Completion (Estimated): March 13, 2056
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)