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.
Prematurity is an important maternal and child health problem due to its incidence and associated complications. Anaemia is a frequent problem in extremely preterm infants (EPI) whose treatment often requires red blood cell (RBC) transfusion. This product is currently obtained from adult blood (AB) donor. The incidence of some prematurity complications have been demonstrated to increase with AB-RBC tranfusions mainly because of the higher oxygen tissue release, such as retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), and necrotizing enterocolitis (NEC). In addition, AB-RBC could contain small amounts of heavy metals that could be toxic for EPI. RBC from umbilical cord blood (UCB-RBC) might be a better alternative as it does not change the hemoglobin profile and consequently might decrease the oxygen toxicity. Several studies have evaluated the safety of UCB-RBC transfusions in preterm infants without finding a higher risk of complications compared with AB-RBC transfusions. A pilot study has been designed to evaluate the safety of UCB-RBC for transfusion in EPI and to determine the feasibility and efficacy of UCB-RBC for transfusion in this group of patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
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.
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.
Hospital Clinic of Barcelona
Barcelona, Barcelona, Spain
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)
Time frame: 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
Time frame: 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
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
Time frame: 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
Time frame: 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
Time frame: 24 hours after the procedure
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Feasibility of UCB-RBC in EPI
Feasibility will be considered proven if UCB-RBC is available in \>50% of patients
Time frame: within 6 hours of the request
Total volumen of RBC transfused in transfused patients
Total volumen of RBC transfused measured in milliliters will be evaluated to assess the efficacy of UCB-RBC in EPI according to the treatment group (only UCB-RBC, only AB-RBC, both)
Time frame: An average of 3 month (when patients are 36 weeks of postmenstrual age)
Number of RBC tranfusions in transfused patients
The total number of RBC transfusions will be evaluated to assess the efficacy of UCB-RBC in EPI according to the treatment group (only UCB-RBC, only AB-RBC, both)
Time frame: 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
The number of days between two consecutive RBC transfusion in each transfused patient will be evaluated to assess the efficacy of UCB-RBC in EPI according to the treatment group (only UCB-RBC, only AB-RBC, both)
Time frame: An average of 3 month (when patients are 36 weeks of postmenstrual age)
Total hemoglobin value (g/dl) in transfused patients
Total hemoglobin (g/dl) in transfused patients will be evaluated to assess the efficacy of UCB-RBC in EPI according to the type of transfusion (UCB-RBC vs AB-RBC) An increment in total hemoglobin by 4 ± 2 g / dL 24 hours after the transfusion will be considered significative. Samples will be analysed by microhematocrit method ("Rapidpoint 5000 system, Siemens").
Time frame: Before transfusion, 24 hours, 1 week, 1 month after transfusion
Hematocrit value (%) in transfused patients
Hematocrit (%) in transfused patients will be evaluated to assess the efficacy of UCB-RBC in EPI according to the type of transfusion (UCB-RBC vs AB-RBC) An increment in hematocrit by 12 ± 5 points 24 hours after the transfusion will be considered significative. Samples will be analysed by microhematocrit method ("Rapidpoint 5000 system, Siemens").
Time frame: Before transfusion, 24 hours, 1 week, 1 month after transfusion
Fetal haemoglobin value (%) in transfused patients
Fetal haemoglobin (%) in transfused patients will be evaluated to assess the efficacy of UCB-RBC in EPI according to the type of transfusion (UCB-RBC vs AB-RBC) A variation of fetal haemoglobin percentage between values before and after the transfusion will be considered significative. It will be analysed by capillary electrophoresis ("Capillary neonatal Hb" kit).
Time frame: Before transfusion, 24 hours, 1 week, 1 month after transfusion
Regional cerebral and somatic oxygen saturation (%) value
Regional cerebral and somatic oxygen saturation (%) in transfused patients will be evaluated to assess the efficacy of UCB-RBC in EPI according to the type of transfusion (UCB-RBC vs AB-RBC). Measurements will be taken by near-infrared spectroscopy
Time frame: Before transfusion, 24 hours, 1 week, 1 month after transfusion