Anemia of Prematurity Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of Autologous Cord Blood Transfusions in Premature Infants
The purpose of this study is to investigate the efficacy and safety of autologous cord blood transfusions in very-low-birth-weight premature infants, and to evaluate the developmental outcomes of the infants who received autologous transfusions.
Blood transfusions have many risks including transfusion reactions and infections. Cord
blood is accepted as an alternative method for red cell transfusions in low-birth weight
(LBW) premature newborns. However, experience and scientific evidence concerning in-vivo
efficacy and safety of red blood cell (RBC) concentrates derived from cord blood in very LBW
premature newborns is still insufficient.
A total of 50 umbilical cord blood (UCB) collected from infants born before 32 weeks'
gestational age and processed into autologous RBC products. Infants requiring blood
transfusion were randomly assigned to an autologous or allogeneic product. Two randomized
groups were compared on the 14th, 28th, 35th days and >35th days with respect to hemoglobin
levels, transfusion numbers, transfusion and phlebotomy volumes, and hemoglobin,
reticulocyte counts and erythropoietin levels in the postconceptional 36th and 40th weeks'
gestation, and hemoglobin levels at postnatal 6-months age. All transfused infants were
developmentally assessed by the end of the postnatal first year.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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