Using umbilical cord blood for transfusions in preterm infants
Safety, Feasibility and Efficacy of Red Blood Cells From Umbilical Cord Blood for Transfusion of Extremely Preterm Infants: Clinical Phase
This study is testing if using red blood cells from umbilical cord blood can safely help extremely preterm infants with anemia feel better compared to traditional blood from adult donors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | N/A to 12 Weeks |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05612919 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of red blood cells derived from umbilical cord blood (UCB-RBC) for transfusions in extremely preterm infants (EPI) suffering from anemia of prematurity. The research compares UCB-RBC transfusions to traditional red blood cells from adult donors, focusing on potential complications associated with adult blood transfusions, such as retinopathy of prematurity and bronchopulmonary dysplasia. The study will involve preterm infants born before 28 weeks of gestation, and it will assess both the feasibility and efficacy of using UCB-RBC as a safer alternative. The goal is to demonstrate that UCB-RBC is a viable option for treating anemia in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born earlier than 28 weeks of gestational age who are admitted to the neonatal intensive care unit.
Not a fit: Patients who have had previous transfusions, major congenital malformations, or are in extreme urgency for blood availability may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer transfusion option for extremely preterm infants, potentially reducing the risk of complications associated with adult blood transfusions.
How similar studies have performed: Previous studies have shown that UCB-RBC transfusions in preterm infants do not carry a higher risk of complications compared to adult blood transfusions, indicating a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Barcelona
- Hospital Clinic of Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Miguel María Alsina Casanova, MD — Hospital Clinic of Barcelona
- Study coordinator: Miguel María Alsina Casanova, MD
- Email: mmalsina@clinic.cat
- Phone: 0034 93 227 56 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.