Red Blood Cells From Umbilical Cord for Transfusion of Preterm Infants

Hospital Clinic of Barcelona

Status: Completed

Conditions: Umbilical Cord Issue; Infant, Extremely Premature; Erythrocyte Transfusion

Treatments: Other: Red blood cell from adult donor; Other: Red blood cell from umbilical cord blood

Study type: Interventional

Funder types: Other

Identifiers

NCT05612919

BST-TSCU-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: Under 12 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

41 participants in 3 patient groups

Patients exclusively transfused with UCB-RBC

Experimental group

Description:

Interventional group infants arm will receive UCB-RBC bag when RBC transfusion is indicated as per standard practice, and when UCB-RBC is available within the first 6 hours of the request.

Treatment:

Other: Red blood cell from umbilical cord blood

Patients exclusively transfused with AB-RBC

Active Comparator group

Description:

Standard treatment group infants arm will receive AB-RBC when RBC transfusion is indicated as per standard practice, and compatible UCB-RBC bag is not available.

Treatment:

Other: Red blood cell from adult donor

Non transfused patients

No Intervention group

Description:

Patients with no indications for RBC transfusion. Their clinical management will be the usual in our neonatal unit.