Ethical Biobanking in Extremely Preterm Infants: Lessons From the EPITOP Study

极早产儿生物样本库的伦理问题:来自EPITOP研究的启示

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Abstract

AIM: The Extremely Preterm Infant Target Optimise and Prevent (EPITOP) study aimed to develop an ethical and practical approach to biobanking salvaged residual blood samples from extremely preterm infants (< 28 weeks gestational age, GA) for biomarker research while minimising clinical risks and addressing ethical concerns. METHODS: Initiated in collaboration with Sahlgrenska University Hospital and Biobank Väst, Region Västra Götaland, Sweden, residual blood samples were collected from infants admitted to the neonatal intensive care unit (NICU) from March 2020 to March 2024. Samples were ethically salvaged and biobanked following parental consent and in compliance with Sweden's Biobank Act. RESULTS: Among 215 eligible infants (mean (GA) 25.4 weeks), 122 consents enabled the collection of 4238 residual samples, of which 92.5% were from blood gas analyses. Sample collection was highest during the first weeks of life, with a median of 35 samples per infant. A higher number of morbidities and lower GA were both associated with an increase in sample numbers. Plasma and whole blood aliquots were prepared and stored for future biomarker studies. CONCLUSION: The EPITOP study demonstrates the feasibility of ethically biobanking salvaged residual blood samples from extremely preterm infants. This approach minimises clinical risks while supporting biomarker discovery, providing a scalable model for neonatal research.

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