- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02101086
Autologous Cord Blood Transfusion in Preterm Infants
Evaluation of the Efficacy and Safety of Autologous Cord Blood Transfusions in Premature Infants
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey, 06100
- Ankara University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ankara University-06
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