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Completed

NCT Number: NCT02101086

Autologous Cord Blood Transfusion in Preterm 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.

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Key information

Conditions

Anemia of Prematurity Anemia Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University School of Medicine

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood transfusion

Other

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 outcomes

  1. Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion

    Time frame: one year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Apr 1, 2014
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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