Clinical trial NCT05612919: Red Blood Cells From Umbilical Cord for Transfusion of Preterm Infants
Official title: Safety, Feasibility and Efficacy of Red Blood Cells From Umbilical Cord Blood for Transfusion of Extremely Preterm Infants: Clinical Phase
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant, Extremely Premature
Erythrocyte Transfusion
Umbilical Cord Issue
Keywords: Anaemia of prematurity
Extremely preterm infants
Umbilical cord blood
Blood bank
Fetal hemoglobin
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Banc de Sang i Teixits
name: Institut d'Investigacions Biomèdiques August Pi i Sunyer
First posted: 2022-11-10
Enrollment: 30
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot, open, non-randomized, single-center clinical study, whose main objective is to evaluate the safety, feasibility and efficacy of red blood cell from umbilical cord blood (UCB-RBC) transfusion in extremely preterm infants (EPI).

When infants fit criteria for red blood cells transfusion the blood bank of reference will be contacted and availability of compatible UCB-RBC bags within those 6 hours will be checked. When it is possible (available compatible UCB-RBC bag within 6 hours), UCB-RBC will be transfused, otherwise patient will receive RBC from adult donor. Patients who initially received RBC from adult donor will remain in this group if repeated transfusions are needed. In patients who initially received UCB-RBC transfusion, availability of compatible UCB-RBC bags will have to be reviewed again. Only when it is not possible to transfuse UCB-RBC at this repeated occasion, the patient will receive RBC from adult blood donor.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with abnormal physical examination after red blood cells from umbilical cord blood (UCB-RBC) transfusion
timeFrame: 24 hours after the procedure
measure: Number of participants with abnormal vital signs after UCB-RBC transfusion
timeFrame: 24 hours after the procedure
measure: Number of participants with altered value of continous monitoring of regional cerebral and somatic oxygen saturation by near-infrared spectroscopy after UCB-RBC transfusion
timeFrame: 24 hours after the procedure
measure: Number of participants with abnormalities in the result of acid-base balance and ionogram after UCB-RBC transfusion
timeFrame: 24 hours after the procedure
measure: Number of participants with morbidities up to 36 weeks of postmenstrual age after UCB-RBC transfusion
timeFrame: 24 hours after the procedure
Secondary outcomes:
measure: Feasibility of UCB-RBC in EPI
timeFrame: within 6 hours of the request
measure: Total volumen of RBC transfused in transfused patients
timeFrame: An average of 3 month (when patients are 36 weeks of postmenstrual age)
measure: Number of RBC tranfusions in transfused patients
timeFrame: An average of 3 month (when patients are 36 weeks of postmenstrual age)
measure: The number of days between two consecutive RBC transfusion in transfused patients
timeFrame: An average of 3 month (when patients are 36 weeks of postmenstrual age)
measure: Total hemoglobin value (g/dl) in transfused patients
timeFrame: Before transfusion, 24 hours, 1 week, 1 month after transfusion
measure: Hematocrit value (%) in transfused patients
timeFrame: Before transfusion, 24 hours, 1 week, 1 month after transfusion
measure: Fetal haemoglobin value (%) in transfused patients
timeFrame: Before transfusion, 24 hours, 1 week, 1 month after transfusion
measure: Regional cerebral and somatic oxygen saturation (%) value
timeFrame: Before transfusion, 24 hours, 1 week, 1 month after transfusion
Other outcomes:
measure: Marrow regeneration
timeFrame: 1 month
measure: Ferritin value in transfused and non-transfused patients
timeFrame: 1 month
measure: Transferrin saturation index (%) in transfused and non-transfused patients
timeFrame: 1 month
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Miguel María Alsina Casanova, MD
role: PRINCIPAL_INVESTIGATOR
References:
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