Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm Infants
Starting soon · Not applicable
Conditions studied: Extremely Premature Infant, Anemia Neonatal, Blood Transfusion, Umbilical Cord Blood, Fetal Hemoglobin, Bronchopulmonary Dysplasia (BPD), Retinopathy of Prematurity (ROP), Death; Neonatal, Intensive Care Units, Neonatal
In brief
Anemia is a condition in which there are not enough red blood cells to carry oxygen throughout the body. It is very common in extremely preterm infants (born before 28 weeks of pregnancy), and many of these babies require red blood cell transfusions during their hospital stay. Currently, transfusions are given using red blood cells donated by adults. An alternative option is to use red blood cells collected from umbilical cord blood, which may be more similar to a newborn's own blood. This approach has been used in some neonatal units with encouraging results and no reported safety concerns. This study aims to determine whether transfusion with umbilical cord blood improves clinical outcomes and reduces potential side effects compared to standard adult donor blood transfusion in extremely preterm infants. We hypothesize that umbilical cord blood transfusion will be at least as safe as adult donor blood and may provide clinical benefits. About 115 extremely preterm infants admitted to neonatal units in Catalonia will participate. If parents agree, their baby will be randomly assigned to receive either compatible umbilical cord blood or compatible adult donor blood if a transfusion becomes necessary. Babies will only receive a transfusion if they clinically need one. If cord blood is not available at the time of transfusion, the baby will receive compatible adult donor blood regardless of the assigned group. To evaluate the response to treatment, small blood samples will be collected at birth, at one month of life, and 24 hours after any transfusion. These samples are taken at the same times as routine blood tests, so participation does not require additional needle sticks. The amount of blood collected is minimal (about 0.2 mL per sample). In addition, a painless and non-invasive sensor will be placed on the baby's head for 24 hours to measure oxygen delivery to the brain. Urine samples will also be collected before and after transfusion to help assess how oxygen reaches body tissues. Participation will continue until the baby reaches 36 weeks of postmenstrual age or is discharged from the hospital, whichever comes first.
Key facts
- Study ID
- NCT07502781
- Run by
- Hospital Clinic of Barcelona
- People needed
- 176
- Starts
- 2027-01-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-03-31
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent obtained from parents or legal guardians.
- Gestational age at birth < 28 weeks or birth weight < 1000 g.
- Admission to one of the participating neonatal intensive care units (NICUs) in the Barcelona area.
You may not qualify if…
- Prior red blood cell transfusion during the fetal or neonatal period.
- Maternal-fetal immunization (e.g., isoimmunization).
- Fetal hydrops.
- Major congenital malformations.
- Congenital infections.
- Immediate need for blood before randomization (e.g., hemorrhagic shock, consumptive coagulopathy).
- Participation in another clinical trial that could interfere with the primary outcome.
Where it is running
- Hospital Clínic de Barcelona - Maternitat — Barcelona, Spain
Full record on ClinicalTrials.gov
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