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.
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.
Prior red blood cell transfusion during the fetal or neonatal period.
Maternal-fetal immunization (e.g., isoimmunization).
Fetal hydrops.
Major congenital malformations.
Parallel
Cord Blood Red Blood Cells
Biological/VaccineNeonates receive transfusions of red blood cells derived from allogeneic umbilical cord blood, ABO/RhD compatible. Dosage: 15-20 mL/kg per transfusion, administered according to clinical indication and availability. If cord blood is not available at the time of transfusion, adult donor red blood cells (CH-SA) are given instead. Monitoring: Vital signs, complete blood count, hematocrit, fetal hemoglobin (HbF), and tissue oxygenation (via NIRS) are recorded before and after transfusion.
Standard Adult Donor Red Blood Cells
Biological/VaccineNeonates receive transfusions of red blood cells derived from adult donors, ABO/RhD compatible. Dosage: 15-20 mL/kg per transfusion, administered according to clinical indication and the protocol of each neonatal unit. Transfusions are performed only when medically necessary. Monitoring: Vital signs, complete blood count, hematocrit, fetal hemoglobin (HbF), and tissue oxygenation (via NIRS) are recorded before and after transfusion.
Composite outcome of bronchopulmonary dysplasia, retinopathy of prematurity, or death in extremely prematurs
The primary outcome is the occurrence of: * Bronchopulmonary dysplasia (BPD, any grade) defined as the need for oxygen therapy or any respiratory support at 36 weeks postmenstrual age (PMA). Classified according to Jensen et al. (2019), assessed at 36 weeks PMA. * Retinopathy of prematurity (ROP, any stage) diagnosed according to the International Classification of Retinopathy of Prematurity, assessed by ophthalmologists blinded to group allocation using ophthalmoscopy and the Catalonia Ophthalmic Telemedicine Network (RTOC). * Death before 36 weeks postmenstrual age or hospital discharge, whichever occurs first. This composite outcome is used to evaluate the clinical benefit of cord blood-derived red blood cell transfusions compared to standard adult donor transfusions in extremely preterm infants.
Fetal hemoglobin (HbF) threshold at one month associated with clinical outcomes
To evaluate the fetal haemoglobin (HbF) percentage cutoff at one month of life that best correlates with a reduction in the composite outcome of retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), or death, as well as with each outcome individually. Due to limited availability of cord blood units (CB-RBC), some infants assigned to this group may receive adult donor red blood cells. This analysis aims to identify protective or critical HbF thresholds for the development of ROP and BPD.
Oxygen-free days within 90 days post-randomization
To evaluate the impact of cord blood-derived red blood cell transfusion (CB-RBC) versus standard adult donor red blood cell transfusion (AD-RBC) on intermediate outcomes, specifically the number of oxygen-free days during the 90 days following randomization.
Hematologic parameters post-transfusion (1)
Assessment of transfusion efficacy via changes in total hematocrit.An increment in hematocrit by 12 ± 5 points 24 hours after the transfusion will be considered effective. This analysis aims to demonstrate non-inferiority of CB-RBC vs AD-RBC.
Hematologic parameters post-transfusion (2)
Assessment of transfusion efficacy via changes in total hemoglobin. An increment in total hemoglobin by 4 ± 2 g / dL 24 hours after the transfusion will be considered effective. Samples will be analysed by microhematocrit method. This analysis aims to demonstrate non-inferiority of CB-RBC vs AD-RBC.
Fetal hemoglobin (HbF) percentage evolution
Measure changes in HbF percentage over time (at birth, pre- and post-transfusion, and at 1 month), evaluating its association with intermediate and clinical outcomes.
Tissue oxygenation measured by NIRS
Evaluate cerebral oxygenation changes using near-infrared spectroscopy (NIRS ("INVOS 5100C Cerebral/somatic oximeter "(Medtronic Minneapolis, MM)) during and 24 hours after transfusion to assess tissue oxygen delivery.
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Hospital Clinic of Barcelona
Lead sponsor
Hospital Sant Joan de Deu
Collaborator
Hospital de la Santa creu i Sant Pau - Barcelona
Collaborator
Hospital Vall d'Hebron
Collaborator
Germans Trias i Pujol Hospital
Collaborator
Parc Taulí Hospital Universitari
Collaborator
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