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Autologous Cord Blood Transfusion in Preterm Infants

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ClinicalTrials.gov Identifier: NCT02101086
Recruitment Status : Completed
First Posted : April 1, 2014
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
Emel Okulu, Ankara University

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.

Condition or disease Intervention/treatment Phase
Anemia of Prematurity Other: Blood transfusion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Autologous Cord Blood Transfusions in Premature Infants
Study Start Date : March 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion [ Time Frame: one year ]

Secondary Outcome Measures :
  1. The hemoglobin levels at postnatal 14th days [ Time Frame: 14 days ]
  2. The hemoglobin levels at postnatal 28th days [ Time Frame: 28 days ]
  3. The hemoglobin levels at postnatal 35th days [ Time Frame: 35 days ]
  4. The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 36 weeks [ Time Frame: 3 months ]
  5. The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 40 weeks [ Time Frame: 5 months ]
  6. Developmental assessments of infants [ Time Frame: One year ]


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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101086


Locations
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Turkey
Ankara University School of Medicine
Ankara, Turkey, 06100
Sponsors and Collaborators
Ankara University
Investigators
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Study Director: Saadet Arsan, Professor Ankara University

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Responsible Party: Emel Okulu, MD, Ankara University
ClinicalTrials.gov Identifier: NCT02101086    
Other Study ID Numbers: Ankara University-06
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014
Keywords provided by Emel Okulu, Ankara University:
umbilical cord blood
premature
autologous transfusion
allogeneic transfusion
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications