Autologous Cord Blood Transfusion in Preterm Infants
Primary Purpose
Anemia of Prematurity
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Blood transfusion
Sponsored by
About this trial
This is an interventional treatment trial for Anemia of Prematurity focused on measuring umbilical cord blood, premature, autologous transfusion, allogeneic transfusion
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
Sites / Locations
- Ankara University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Autologous Cord Blood Transfusion
Allogeneic blood transfusion
Arm Description
Autologous cord blood transfusion 10 mL per kg for anemia
Allogeneic blood transfusion 10 mL per kg for anemia
Outcomes
Primary Outcome Measures
Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion
Secondary Outcome Measures
The hemoglobin levels at postnatal 14th days
The hemoglobin levels at postnatal 28th days
The hemoglobin levels at postnatal 35th days
The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 36 weeks
The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 40 weeks
Developmental assessments of infants
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02101086
Brief Title
Autologous Cord Blood Transfusion in Preterm Infants
Official Title
Evaluation of the Efficacy and Safety of Autologous Cord Blood Transfusions in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Prematurity
Keywords
umbilical cord blood, premature, autologous transfusion, allogeneic transfusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous Cord Blood Transfusion
Arm Type
Experimental
Arm Description
Autologous cord blood transfusion 10 mL per kg for anemia
Arm Title
Allogeneic blood transfusion
Arm Type
Active Comparator
Arm Description
Allogeneic blood transfusion 10 mL per kg for anemia
Intervention Type
Other
Intervention Name(s)
Blood transfusion
Intervention Description
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
Primary Outcome Measure Information:
Title
Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion
Time Frame
one year
Secondary Outcome Measure Information:
Title
The hemoglobin levels at postnatal 14th days
Time Frame
14 days
Title
The hemoglobin levels at postnatal 28th days
Time Frame
28 days
Title
The hemoglobin levels at postnatal 35th days
Time Frame
35 days
Title
The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 36 weeks
Time Frame
3 months
Title
The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 40 weeks
Time Frame
5 months
Title
Developmental assessments of infants
Time Frame
One year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saadet Arsan, Professor
Organizational Affiliation
Ankara University
Official's Role
Study Director
Facility Information:
Facility Name
Ankara University School of Medicine
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Autologous Cord Blood Transfusion in Preterm Infants
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