Autologous Cord Blood Transfusion in Preterm Infants

Anemia of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101086
• Other study ID #: Ankara University-06
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: March 28, 2014
• Start date: March 2009
• Est. completion date: January 2012

Study information

• Verified date: March 2014
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia of Prematurity
• Anemia, Neonatal
• Infant, Premature, Diseases

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara University School of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion		one year	Yes
Secondary	The hemoglobin levels at postnatal 14th days		14 days	No
Secondary	The hemoglobin levels at postnatal 28th days		28 days	No
Secondary	The hemoglobin levels at postnatal 35th days		35 days	No
Secondary	The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 36 weeks		3 months	No
Secondary	The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 40 weeks		5 months	No
Secondary	Developmental assessments of infants		One year	No