Autologous Cord Blood Transfusion in Preterm Infants

NCT ID: NCT02101086

Last Updated: 2014-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-01-31

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.

Conditions

Anemia of Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Autologous Cord Blood Transfusion

Autologous cord blood transfusion 10 mL per kg for anemia

Group Type: EXPERIMENTAL

Blood transfusion

Intervention Type: OTHER

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

Allogeneic blood transfusion

Allogeneic blood transfusion 10 mL per kg for anemia

Group Type: ACTIVE_COMPARATOR

Blood transfusion

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

Emel Okulu

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saadet Arsan, Professor

Role: STUDY_DIRECTOR

Ankara University

Locations

Ankara University School of Medicine

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Ankara University-06

Identifier Type: -

Identifier Source: org_study_id