Trial-related blood sampling and red blood cell transfusions in preterm infants
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Aim: To determine if trial-related blood sampling increases the risk of later red blood cell (RBC) transfusion in very preterm infants, we compared the volume of clinical- and trial-related blood samples, in a specific trial and correlated to subsequent RBC transfusion. Methods: For 193 very preterm infants, participating in the FortiColos trial (NCT03537365), trial-related blood volume drawn was in accordance with ethical considerations established by the European Commission. Medical records were reviewed to assess the number and accumulated volume (mL/kg) of blood samples (both clinical- and trial-related). Data were compared with the need of RBC transfusions during the first 28 days of life. Results: Mean (SD) gestational age and birth weight was 28 ± 1 weeks and 1168 ± 301 g. In total, 11% of total blood volume was drawn for sampling (8.1 ± 5.1 mL/kg) and trial-related sampling accounted for 1.6 ± 0.6 mL/kg. Trial-related blood sampling had no impact on RBC transfusion (p = 0.9). Conclusion: Clinical blood sampling in very preterm infants is associated with blood loss and subsequent need for RBC transfusions. In a specific trial requiring blood samples, we found no additional burden of trial-related blood sampling. The study suggests that trial-related sampling is safe if European criteria are followed.
Originalsprog | Engelsk |
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Tidsskrift | Acta Paediatrica |
Vol/bind | 112 |
Udgave nummer | 12 |
Sider (fra-til) | 2486-2492 |
ISSN | 0803-5253 |
DOI | |
Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:
The FortiColos study was funded by the Innovation Fund Denmark and the company Biofiber Damino, Gesten, Denmark.
Publisher Copyright:
© 2023 The Authors. Acta Paediatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Paediatrica.
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