CompletedNot Applicable

Red Blood Cells From Umbilical Cord for Transfusion of Preterm Infants

Spain41 participantsStarted 2023-09-13

Plain-language 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.

Who can participate

Age range

12 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 24 hours after the procedure

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

Timeframe: 24 hours after the procedure

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

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

Timeframe: 24 hours after the procedure

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

Timeframe: 24 hours after the procedure

Trial details

NCT IDNCT05612919

SponsorHospital Clinic of Barcelona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-12

View on ClinicalTrials.gov More Infant, Extremely Premature trials

Plain-language summary

Who can participate

Age range

12 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 24 hours after the procedure

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

Timeframe: 24 hours after the procedure

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

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

Timeframe: 24 hours after the procedure

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

Timeframe: 24 hours after the procedure