NCT02101086

Autologous Cord Blood Transfusion in Preterm Infants

Evaluation of the Efficacy and Safety of Autologous Cord Blood Transfusions in Premature Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anemia of Prematurity

Interventions

Type	Name	Description
OTHER	Blood transfusion	Whenever the infant indicated to receive transfusion, a blood product request was sent to the blood bank. This infant was randomly assigned to the autologous or the allogeneic product labeled for each patient at birth in the blood bank

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-09-01
• Completion: 2012-01-01
• First posted: 2014-04-01
• Last updated: 2014-04-01

Locations

1 site across 1 country: Turkey (Türkiye)