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NCT Number: NCT05612919

Red Blood Cells From Umbilical Cord for Transfusion of Preterm Infants

This study has been designed to demonstrate that red blood cell from umbilical cord blood (UCB-RBC) is a safe and available product for extremely preterm infants (EPI) transfusion and that transfusion of UCB-RBC is non-less effective than RBC from adult donor for the treatment of anemia of prematurity in this group of patients.

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Key information

Conditions

Infant, Extremely Premature Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Erythrocyte Transfusion Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Thalassemia Umbilical Cord Issue beta-Thalassemia

Age range

Up to 12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic of Barcelona

Barcelona, 08028, Spain

About this study

Prematurity is an important maternal and child health problem due to its incidence and associated complications. Anaemia is a frequent problem in extremely preterm infants (EPI) whose treatment often requires red blood cell (RBC) transfusion. This product is currently obtained from adult blood (AB) donor. The incidence of some prematurity complications have been demonstrated to increase with AB-RBC tranfusions mainly because of the higher oxygen tissue release, such as retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), and necrotizing enterocolitis (NEC). In addition, AB-RBC could contain small amounts of heavy metals that could be toxic for EPI.

RBC from umbilical cord blood (UCB-RBC) might be a better alternative as it does not change the hemoglobin profile and consequently might decrease the oxygen toxicity.

Several studies have evaluated the safety of UCB-RBC transfusions in preterm infants without finding a higher risk of complications compared with AB-RBC transfusions.

A pilot study has been designed to evaluate the safety of UCB-RBC for transfusion in EPI and to determine the feasibility and efficacy of UCB-RBC for transfusion in this group of patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent from parents or legal guardians
  • Preterm infants born earlier than 28 weeks of gestational age.
  • Admission to the neonatal intensive care unit of the participating hospital (Hospital Clínic of Barcelona)

Exclusion criteria

  • Previous transfusion
  • Isoimmunization
  • Hydrops fetalis
  • Major congenital malformations
  • Congenital infections
  • Hemoglobinopathies
  • Extreme urgency of blood availability (hypovolemic shock, disseminated intravascular coagulopathy...)
  • Be part of another clinical trial that may interfere with the results

Treatment and study plan

Red blood cell from umbilical cord blood

Other

Patients will receive a volume of 15-20 ml/kg of red blood cell from umbilical cord blood (UCB-RBC). The transfusion will be prescribed and administered with all the routine safety measures carried out by the nurses to ensure compatibility between the administered RBC and the patient. The UCB-RBC bags will contain a minimum volume of 20 mL of RBC, with a haematocrit of about 60% and an acceptable residual leucocyte content of <106/mm3.

Product validation is currently under development.

Red blood cell from adult donor

Other

Patients will receive a volume of 15-20 ml/kg of red blood cell from adult donor according to standard guidelines.

The transfusion will be prescribed and administered with all the routine safety measures carried out by the nurses to ensure compatibility between the administered RBC and the patient.

Blood samples are irradiated according to standard practise.

Primary outcomes

  1. Number of participants with abnormal physical examination after red blood cells from umbilical cord blood (UCB-RBC) transfusion

    Time frame: 24 hours after the procedure

    The number of participants with abnormal physical examination after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in extremely preterm infants (EPI)

  2. Number of participants with abnormal vital signs after UCB-RBC transfusion

    Time frame: 24 hours after the procedure

    The number of participants with abnormal physical examination after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI

  3. Number of participants with altered value of continous monitoring of regional cerebral and somatic oxygen saturation by near-infrared spectroscopy after UCB-RBC transfusion

    Time frame: 24 hours after the procedure

    The number of participants with Altered value of continous monitoring of regional cerebral and somatic oxygen saturation by near-infrared spectroscopy after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI

  4. Number of participants with abnormalities in the result of acid-base balance and ionogram after UCB-RBC transfusion

    Time frame: 24 hours after the procedure

    The number of participants with abnormalities in the result of acid-base balance and ionogram after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI

  5. Number of participants with morbidities up to 36 weeks of postmenstrual age after UCB-RBC transfusion

    Time frame: 24 hours after the procedure

    The number of participants with Morbidities up to 36 weeks of postmenstrual age after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI

Secondary outcomes

  1. Feasibility of UCB-RBC in EPI

    Time frame: within 6 hours of the request

    Feasibility will be considered proven if UCB-RBC is available in >50% of patients

  2. Total volumen of RBC transfused in transfused patients

    Time frame: An average of 3 month (when patients are 36 weeks of postmenstrual age)

    Total volumen of RBC transfused measured in milliliters will be evaluated to assess the efficacy of UCB-RBC in EPI according to the treatment group (only UCB-RBC, only AB-RBC, both)

  3. Number of RBC tranfusions in transfused patients

    Time frame: An average of 3 month (when patients are 36 weeks of postmenstrual age)

    The total number of RBC transfusions will be evaluated to assess the efficacy of UCB-RBC in EPI according to the treatment group (only UCB-RBC, only AB-RBC, both)

  4. The number of days between two consecutive RBC transfusion in transfused patients

    Time frame: An average of 3 month (when patients are 36 weeks of postmenstrual age)

    The number of days between two consecutive RBC transfusion in each transfused patient will be evaluated to assess the efficacy of UCB-RBC in EPI according to the treatment group (only UCB-RBC, only AB-RBC, both)

  5. Total hemoglobin value (g/dl) in transfused patients

    Time frame: Before transfusion, 24 hours, 1 week, 1 month after transfusion

    Total hemoglobin (g/dl) in transfused patients will be evaluated to assess the efficacy of UCB-RBC in EPI according to the type of transfusion (UCB-RBC vs AB-RBC) An increment in total hemoglobin by 4 ± 2 g / dL 24 hours after the transfusion will be considered significative. Samples will be analysed by microhematocrit method ("Rapidpoint 5000 system, Siemens").

  6. Hematocrit value (%) in transfused patients

    Time frame: Before transfusion, 24 hours, 1 week, 1 month after transfusion

    Hematocrit (%) in transfused patients will be evaluated to assess the efficacy of UCB-RBC in EPI according to the type of transfusion (UCB-RBC vs AB-RBC) An increment in hematocrit by 12 ± 5 points 24 hours after the transfusion will be considered significative. Samples will be analysed by microhematocrit method ("Rapidpoint 5000 system, Siemens").

  7. Fetal haemoglobin value (%) in transfused patients

    Time frame: Before transfusion, 24 hours, 1 week, 1 month after transfusion

    Fetal haemoglobin (%) in transfused patients will be evaluated to assess the efficacy of UCB-RBC in EPI according to the type of transfusion (UCB-RBC vs AB-RBC) A variation of fetal haemoglobin percentage between values before and after the transfusion will be considered significative. It will be analysed by capillary electrophoresis ("Capillary neonatal Hb" kit).

  8. Regional cerebral and somatic oxygen saturation (%) value

    Time frame: Before transfusion, 24 hours, 1 week, 1 month after transfusion

    Regional cerebral and somatic oxygen saturation (%) in transfused patients will be evaluated to assess the efficacy of UCB-RBC in EPI according to the type of transfusion (UCB-RBC vs AB-RBC). Measurements will be taken by near-infrared spectroscopy

Other outcomes

  1. Marrow regeneration

    Time frame: 1 month

    Comparison of reticulocyte counts between transfused and non-transfused patients.

  2. Ferritin value in transfused and non-transfused patients

    Time frame: 1 month

    Ferritin value will be assessed to comparison iron metabolism in transfused and non-transfused patients

  3. Transferrin saturation index (%) in transfused and non-transfused patients

    Time frame: 1 month

    Transferrin saturation index (%) will be assessed to comparison iron metabolism in transfused and non-transfused patients

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Banc de Sang i Teixits
  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

Registry information

Official study title

Safety, Feasibility and Efficacy of Red Blood Cells From Umbilical Cord Blood for Transfusion of Extremely Preterm Infants: Clinical Phase

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 10, 2022
Registry last updated
Jan 28, 2026

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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