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

Официальное название

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

Обзор

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.

Первичные конечные точки

• Survival without cognitive impairment [Срок оценки: at the age of 5 years]
• Survival without impaired motor function [Срок оценки: at the age of 5 years]
• Survival without visual impairment [Срок оценки: at the age of 5 years]
• Survival without hearing impairment [Срок оценки: at the age of 5 years]
• Survival without seizures [Срок оценки: at the age of 5 years]

Вторичные конечные точки (8)

• Duration of breast feeding [Срок оценки: 2 years]
• Weight gain [Срок оценки: birth to the age of 18 years]
• Growth in length/height [Срок оценки: birth to the age of 18 years]
• General Movements [Срок оценки: corrected 3 months of age]
• Maternal depression [Срок оценки: 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 [Срок оценки: at the corrected age of 6 months]
• Parental Bonding [Срок оценки: corrected age of 6 and 24 months]
• Social Support [Срок оценки: at the corrected age of 35-40 weeks' gestational age and at the corrected age of 24 months]

Критерии участия

Критерии включения

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

Критерии исключения

• none

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• University Hospital Cologne — Cologne

Идентификаторы

NCT: NCT07490912 · 23-1226

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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