Safety, Feasibility and Efficacy of Red Blood Cells From Umbilical Cord Blood for Transfusion of Extremely Preterm Infants: Clinical Phase
Sponsor study identifier
interventional
41
1 country
1
Study Start
September 13, 2023
Actual (reported)Primary Completion
July 12, 2025
Actual (reported)Study Completion
July 12, 2025
Actual (reported)This study has been designed to demonstrate that red blood cell from umbilical cord blood (UCB-RBC) is a safe and available product for extremely preterm infants (EPI) transfusion and that transfusion of UCB-RBC is non-less effective than RBC from adult donor for the treatment of anemia of prematurity in this group of patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 12, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 5, 2022
Actual (reported)November 10, 2022
Actual (reported)September 13, 2023
Actual (reported)July 12, 2025
Actual (reported)July 12, 2025
Actual (reported)Number of participants with abnormal physical examination after red blood cells from umbilical cord blood (UCB-RBC) transfusion
The number of participants with abnormal physical examination after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in extremely preterm infants (EPI)
24 hours after the procedure
Number of participants with abnormal vital signs after UCB-RBC transfusion
The number of participants with abnormal physical examination after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI
24 hours after the procedure
Number of participants with altered value of continous monitoring of regional cerebral and somatic oxygen saturation by near-infrared spectroscopy after UCB-RBC transfusion
Interventional group infants arm will receive UCB-RBC bag when RBC transfusion is indicated as per standard practice, and when UCB-RBC is available within the first 6 hours of the request.
Standard treatment group infants arm will receive AB-RBC when RBC transfusion is indicated as per standard practice, and compatible UCB-RBC bag is not available.
Patients will receive a volume of 15-20 ml/kg of red blood cell from umbilical cord blood (UCB-RBC). The transfusion will be prescribed and administered with all the routine safety measures carried out by the nurses to ensure compatibility between the administered RBC and the patient. The UCB-RBC bags will contain a minimum volume of 20 mL of RBC, with a haematocrit of about 60% and an acceptable residual leucocyte content of \<106/mm3. Product validation is currently under development.
Hospital Clinic of Barcelona
Barcelona, Barcelona, 08028, Spain
Widness JA. Pathophysiology of Anemia During the Neonatal Period, Including Anemia of Prematurity. Neoreviews. 2008 Nov 1;9(11):e520. doi: 10.1542/neo.9-11-e520.
Jiramongkolchai K, Repka MX, Tian J, Aucott SW, Shepard J, Collins M, Kraus C, Clemens J, Feller M, Burd I, Roizenblatt M, Goldberg MF, Arevalo JF, Gehlbach P, Handa JT. Lower foetal haemoglobin levels at 31- and 34-weeks post menstrual age is associated with the development of retinopathy of prematurity : PacIFiHER Report No. 1 PacIFiHER Study Group (Preterm Infants and Fetal Haemoglobin in ROP). Eye (Lond). 2021 Feb;35(2):659-664. doi: 10.1038/s41433-020-0938-5. Epub 2020 May 14.
Miguel María Alsina Casanova, MD
Hospital Clinic of Barcelona
41 participants (actual enrollment reported by the registry).
First Submitted
The number of participants with Altered value of continous monitoring of regional cerebral and somatic oxygen saturation by near-infrared spectroscopy after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI
24 hours after the procedure
Number of participants with abnormalities in the result of acid-base balance and ionogram after UCB-RBC transfusion
The number of participants with abnormalities in the result of acid-base balance and ionogram after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI
24 hours after the procedure
Number of participants with morbidities up to 36 weeks of postmenstrual age after UCB-RBC transfusion
The number of participants with Morbidities up to 36 weeks of postmenstrual age after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI
24 hours after the procedure
Feasibility of UCB-RBC in EPI
within 6 hours of the request
Total volumen of RBC transfused in transfused patients
An average of 3 month (when patients are 36 weeks of postmenstrual age)
Number of RBC tranfusions in transfused patients
An average of 3 month (when patients are 36 weeks of postmenstrual age)
The number of days between two consecutive RBC transfusion in transfused patients
An average of 3 month (when patients are 36 weeks of postmenstrual age)
Total hemoglobin value (g/dl) in transfused patients
Before transfusion, 24 hours, 1 week, 1 month after transfusion
Marrow regeneration
1 month
Ferritin value in transfused and non-transfused patients
1 month
Transferrin saturation index (%) in transfused and non-transfused patients
1 month
Patients with no indications for RBC transfusion. Their clinical management will be the usual in our neonatal unit.
Patients will receive a volume of 15-20 ml/kg of red blood cell from adult donor according to standard guidelines. The transfusion will be prescribed and administered with all the routine safety measures carried out by the nurses to ensure compatibility between the administered RBC and the patient. Blood samples are irradiated according to standard practise.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Hellstrom W, Martinsson T, Hellstrom A, Morsing E, Ley D. Fetal haemoglobin and bronchopulmonary dysplasia in neonates: an observational study. Arch Dis Child Fetal Neonatal Ed. 2021 Jan;106(1):88-92. doi: 10.1136/archdischild-2020-319181. Epub 2020 Aug 26.
Teofili L, Papacci P, Orlando N, Bianchi M, Molisso A, Purcaro V, Valentini CG, Giannantonio C, Serrao F, Chiusolo P, Nicolotti N, Pellegrino C, Carducci B, Vento G, De Stefano V. Allogeneic cord blood transfusions prevent fetal haemoglobin depletion in preterm neonates. Results of the CB-TrIP study. Br J Haematol. 2020 Oct;191(2):263-268. doi: 10.1111/bjh.16851. Epub 2020 Jun 8.
Mohamed A, Shah PS. Transfusion associated necrotizing enterocolitis: a meta-analysis of observational data. Pediatrics. 2012 Mar;129(3):529-40. doi: 10.1542/peds.2011-2872. Epub 2012 Feb 20.
Bianchi M, Giannantonio C, Spartano S, Fioretti M, Landini A, Molisso A, Tesfagabir GM, Tornesello A, Barbagallo O, Valentini CG, Vento G, Zini G, Romagnoli C, Papacci P, Teofili L. Allogeneic umbilical cord blood red cell concentrates: an innovative blood product for transfusion therapy of preterm infants. Neonatology. 2015;107(2):81-6. doi: 10.1159/000368296. Epub 2014 Nov 15.
Gonzalez EG, Casanova MA, Samarkanova D, Aldecoa-Bilbao V, Teresa-Palacio M, Busquets EF, Figueras-Aloy J, Salvia-Roiges M, Querol S. Feasibility of umbilical cord blood as a source of red blood cell transfusion in preterm infants. Blood Transfus. 2021 Nov;19(6):510-517. doi: 10.2450/2020.0169-20. Epub 2020 Dec 18.
Bianchi M, Orlando N, Barbagallo O, Sparnacci S, Valentini CG, Carducci B, Teofili L. Allogeneic cord blood red blood cells: assessing cord blood unit fractionation and validation. Blood Transfus. 2021 Sep;19(5):435-444. doi: 10.2450/2020.0138-20. Epub 2020 Nov 3.
Kotowski M, Litwinska Z, Klos P, Pius-Sadowska E, Zagrodnik-Ulan E, Ustianowski P, Rudnicki J, Machalinski B. Autologous cord blood transfusion in preterm infants - could its humoral effect be the kez to control prematurity-related complications? A preliminary study. J Physiol Pharmacol. 2017 Dec;68(6):921-927.
Strauss RG, Widness JA. Is there a role for autologous/placental red blood cell transfusions in the anemia of prematurity? Transfus Med Rev. 2010 Apr;24(2):125-9. doi: 10.1016/j.tmrv.2009.11.003.
April 5, 2022
First Posted
November 10, 2022
Study Start
September 13, 2023
Actual (reported)Primary Completion
July 12, 2025
Actual (reported)Study Completion
July 12, 2025
Actual (reported)Last Updated
January 28, 2026
Record last verified: 2023-09
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