Premature Birth, Prematurity Complications, Preterm Infant Development, Preterm Infant Health
Conditions
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
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.
Interventions
None listed
Sponsors
University Hospital of Cologne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival without cognitive impairment | 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 | 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 | at the age of 5 years | Visual impairment is defined as need of visual aid or blindness. |
| Survival without hearing impairment | at the age of 5 years | Hearing impairment is defined as hearing with amplification or hearing loss despite amplification. |
| Survival without seizures | at the age of 5 years | The occurrence of seizures is assessed during follow-up visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of breast feeding | 2 years | Duration of breast feeding is assessed during follow-up visits. |
| Weight gain | birth to the age of 18 years | 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. |
| Growth in length/height | birth to the age of 18 years | 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. |
| General Movements | corrected 3 months of age | 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. |
| 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 | 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. |
| Post-traumatic Stress | at the corrected age of 6 months | 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. |
| Parental Bonding | corrected age of 6 and 24 months | 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. |
| Social Support | at the corrected age of 35-40 weeks' gestational age and at the corrected age of 24 months | 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. |
Countries
Germany
Contacts
CONTACTCharlotte S Schömig, Dr. med.
CONTACTAngela Kribs, Apl. Prof. Dr.
PRINCIPAL_INVESTIGATORAngela Kribs, Apl. Prof. Dr.
University Hospital Cologne
PRINCIPAL_INVESTIGATORMiguel A Alejandre Alcázar, Prof. Dr.
University Hospital Cologne
Outcome results
None listed