Red Blood Cells From Umbilical Cord for Transfusion of Preterm Infants
- Conditions
- Infant, Extremely PrematureUmbilical Cord IssueErythrocyte Transfusion
- Interventions
- Other: Red blood cell from umbilical cord bloodOther: Red blood cell from adult donor
- Registration Number
- NCT05612919
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Signed informed consent from parents or legal guardians
- Preterm infants born earlier than 28 weeks of gestational age.
- Admission to the neonatal intensive care unit of the participating hospital (Hospital Clínic of Barcelona)
- Previous transfusion
- Isoimmunization
- Hydrops fetalis
- Major congenital malformations
- Congenital infections
- Hemoglobinopathies
- Extreme urgency of blood availability (hypovolemic shock, disseminated intravascular coagulopathy...)
- Be part of another clinical trial that may interfere with the results
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients exclusively transfused with UCB-RBC Red blood cell from umbilical cord blood 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. Patients exclusively transfused with AB-RBC Red blood cell from adult donor 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.
- Primary Outcome Measures
Name Time Method Number of participants with abnormal vital signs after UCB-RBC transfusion 24 hours after the procedure The number of participants with abnormal physical examination after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI
Number of participants with abnormal physical examination after red blood cells from umbilical cord blood (UCB-RBC) transfusion 24 hours after the procedure 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)
Number of participants with altered value of continous monitoring of regional cerebral and somatic oxygen saturation by near-infrared spectroscopy after UCB-RBC transfusion 24 hours after the procedure 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
Number of participants with abnormalities in the result of acid-base balance and ionogram after UCB-RBC transfusion 24 hours after the procedure 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
Number of participants with morbidities up to 36 weeks of postmenstrual age after UCB-RBC transfusion 24 hours after the procedure 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
- Secondary Outcome Measures
Name Time Method Number of RBC tranfusions in transfused patients An average of 3 month (when patients are 36 weeks of postmenstrual age) 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)
Feasibility of UCB-RBC in EPI within 6 hours of the request Feasibility will be considered proven if UCB-RBC is available in \>50% of patients
Total volumen of RBC transfused in transfused patients An average of 3 month (when patients are 36 weeks of postmenstrual age) 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)
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) 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)
Total hemoglobin value (g/dl) in transfused patients Before transfusion, 24 hours, 1 week, 1 month after transfusion 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").
Hematocrit value (%) in transfused patients Before transfusion, 24 hours, 1 week, 1 month after transfusion 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").
Fetal haemoglobin value (%) in transfused patients Before transfusion, 24 hours, 1 week, 1 month after transfusion 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).
Regional cerebral and somatic oxygen saturation (%) value Before transfusion, 24 hours, 1 week, 1 month after transfusion 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
Trial Locations
- Locations (1)
Hospital Clinic of Barcelona
🇪🇸Barcelona, Spain