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Ethical Biobanking in Extremely Preterm Infants: Lessons From the EPITOP Study
Ulrika Sjöbom1,2, Jenny Isaksson3, Ruth Wickelgren4,5
1Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Insights
The EPITOP study successfully established an ethical method for biobanking residual blood samples from extremely preterm infants, supporting vital biomarker research with minimal clinical risk.
Area of Science:
- Neonatal Research
- Biobanking
- Biomarker Discovery
Background:
- Extremely preterm infants (<28 weeks gestational age) require specialized care.
- Biomarker research in this population is crucial for understanding and preventing morbidities.
- Ethical and practical challenges exist in collecting samples from this vulnerable group.
Purpose of the Study:
- To develop an ethical and practical biobanking strategy for residual blood samples from extremely preterm infants.
- To minimize clinical risks associated with sample collection.
- To address ethical considerations in neonatal biobanking.
Main Methods:
- Collaboration with Sahlgrenska University Hospital and Biobank Väst.
- Collection of residual blood samples from NICU-admitted infants (March 2020-March 2024).
- Ethical salvage and biobanking post-parental consent, adhering to Sweden's Biobank Act.
Main Results:
- 122 consents obtained from 215 eligible infants (mean GA 25.4 weeks).
- 4238 residual samples collected, primarily from blood gas analyses (92.5%).
- Higher morbidities and lower GA correlated with increased sample numbers; plasma and whole blood aliquots stored.
Conclusions:
- The EPITOP study demonstrates the feasibility of ethically biobanking salvaged residual blood samples from extremely preterm infants.
- This approach minimizes clinical risks while facilitating biomarker discovery.
- The study provides a scalable model for neonatal research biobanking.
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.
