Autologous Cord Blood Transfusion in Preterm Infants

Not Applicable

Completed

• Conditions: Anemia of Prematurity
• Interventions: Other: Blood transfusion

• Registration Number: NCT02101086
• Lead Sponsor: Ankara University

Brief 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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2010-09
• Study Completion: 2012-01
• Status Verified: 2014-03
• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-03-28
• Last Update Submitted: 2014-03-28
• Study First Posted: 2014-04-01
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous Cord Blood Transfusion	Blood transfusion	Autologous cord blood transfusion 10 mL per kg for anemia
Allogeneic blood transfusion	Blood transfusion	Allogeneic blood transfusion 10 mL per kg for anemia

Primary Outcome Measures

Name	Time	Method
Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion	one year

Secondary Outcome Measures

Name	Time	Method
The hemoglobin levels at postnatal 35th days	35 days
The hemoglobin levels at postnatal 14th days	14 days
The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 36 weeks	3 months
The hemoglobin levels at postnatal 28th days	28 days
The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 40 weeks	5 months
Developmental assessments of infants	One year

Trial Locations

Locations (1)

Ankara University School of Medicine; 🇹🇷 Ankara, Turkey