Autologous Cord Blood Transfusion in Preterm Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anemia of Prematurity

Intervention / Treatment
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* Other: Blood transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants born at ≤ 32 weeks gestational age Parental consent Exclusion Criteria: rhesus incompatibility hydrops fetalis maternal viral or bacterial infections including suspected chorioamnionitis parental refuse

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Cord Blood Transfusion<br>Autologous cord blood transfusion 10 mL per kg for anemia | Other: Blood transfusion<br>* 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<br>|
| Active Comparator: Allogeneic blood transfusion<br>Allogeneic blood transfusion 10 mL per kg for anemia | Other: Blood transfusion<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The hemoglobin levels at postnatal 14th days |  | 14 days | 
| The hemoglobin levels at postnatal 28th days |  | 28 days | 
| The hemoglobin levels at postnatal 35th days |  | 35 days | 
| The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 36 weeks |  | 3 months | 
| The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 40 weeks |  | 5 months | 
| Developmental assessments of infants |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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umbilical cord blood, premature, autologous transfusion, allogeneic transfusion