Autologous Cord Blood Transfusion in Preterm Infants

March 28, 2014 updated by: Emel Okulu, Ankara University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ankara University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous Cord Blood Transfusion
Autologous cord blood transfusion 10 mL per kg for anemia
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
Active Comparator: Allogeneic blood transfusion
Allogeneic blood transfusion 10 mL per kg for anemia
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

March 28, 2014

First Posted (Estimate)

April 1, 2014

Study Record Updates

Last Update Posted (Estimate)

April 1, 2014

Last Update Submitted That Met QC Criteria

March 28, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ankara University-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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