Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm Infants

NCT07502781 | Not Yet Recruiting

• 1 other identifier: CBLOOD - PE 01
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Cord blood red blod cell transfusion; Umbilical cord blood transfusion; Extremely preterm infants; Neonatal anemia; Fetal hemoglobin; Adult donor red blood cells; Bronchopulmonary dysplasia; Retinopathy of prematurity; Oxygen delivery; Days requiring oxygen supplementation

Outcome Measures

Primary Outcomes (1)

• 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.

  From birth until 36 weeks postmenstrual age or hospital discharge (whichever occurs first).

Secondary Outcomes (2)

• Fetal hemoglobin (HbF) threshold at one month associated with clinical outcomes

  At one month of life.

• Oxygen-free days within 90 days post-randomization

  Up to 90 days after randomization.

Other Outcomes (9)

• Hematologic parameters post-transfusion (1)

  Pre-transfusion, 24 hours post-transfusion, and at 1 month of age

• Hematologic parameters post-transfusion (2)

  Pre-transfusion, 24 hours post-transfusion, and at 1 month of age

• Fetal hemoglobin (HbF) percentage evolution

  At birth, 24 hours post-transfusion, and 1 month of age

Study Arms (2)

Cord Blood-Derived Red Blood Cell Transfusion

EXPERIMENTAL

Extremely preterm infants randomized to this arm will receive red blood cell transfusions derived from umbilical cord blood (CB-RBC) when a transfusion is clinically indicated according to standard neonatal guidelines. If compatible cord blood units are not available at the time of transfusion, standard adult donor red blood cells may be used.

Biological: Cord Blood Red Blood Cells

Adult Donor Red Blood Cell Transfusion

ACTIVE COMPARATOR

Extremely preterm infants randomized to this arm will receive standard adult donor red blood cell transfusions when a transfusion is clinically indicated according to standard neonatal guidelines.

Biological: Standard Adult Donor Red Blood Cells

Interventions

Cord Blood Red Blood Cells BIOLOGICAL

Neonates 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.

Also known as: CH-SCU

Cord Blood-Derived Red Blood Cell Transfusion

Standard Adult Donor Red Blood Cells BIOLOGICAL

Neonates 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.

Also known as: CH-SA

Adult Donor Red Blood Cell Transfusion

Eligibility Criteria

• Age: 23 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• 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

Study Sites (1)

Hospital Clínic de Barcelona - Maternitat

Barcelona, 08028, Spain

Location

Related Publications (4)

• Torrejon-Rodriguez L, Pinilla-Gonzalez A, Lara Canton I, Albiach-Delgado A, Cascant-Vilaplana MM, Cernada M, Kuligowski J, Solves Alcaina MP, Gomez I, Vento M, Aguar Carrascosa M. Effect of autologous umbilical cord blood transfusion in the development of retinopathy of prematurity: randomized clinical trial - study protocol. Front Pediatr. 2023 Oct 12;11:1269797. doi: 10.3389/fped.2023.1269797. eCollection 2023.

  PMID: 37900679 BACKGROUND

• Teofili L, Papacci P, Dani C, Cresi F, Remaschi G, Pellegrino C, Bianchi M, Ansaldi G, Campagnoli MF, Vania B, Lepore D, Franco FGS, Fabbri M, de Vera d' Aragona RP, Molisso A, Beccastrini E, Dragonetti A, Orazi L, Pasciuto T, Mozzetta I, Baldascino A, Locatelli E, Valentini CG, Giannantonio C, Carducci B, Gabbriellini S, Albiani R, Ciabatti E, Nicolotti N, Baroni S, Mazzoni A, Besso FG, Serrao F, Purcaro V, Coscia A, Pizzolo R, Raffaeli G, Villa S, Mondello I, Trimarchi A, Beccia F, Ghirardello S, Vento G. Cord blood transfusions in extremely low gestational age neonates to reduce severe retinopathy of prematurity: results of a prespecified interim analysis of the randomized BORN trial. Ital J Pediatr. 2024 Aug 7;50(1):142. doi: 10.1186/s13052-024-01714-w.

  PMID: 39113069 BACKGROUND

• Teofili L, Papacci P, Orlando N, Bianchi M, Molisso A, Purcaro V, Valentini CG, Giannantonio C, Serrao F, Chiusolo P, Nicolotti N, Pellegrino C, Carducci B, Vento G, De Stefano V. Allogeneic cord blood transfusions prevent fetal haemoglobin depletion in preterm neonates. Results of the CB-TrIP study. Br J Haematol. 2020 Oct;191(2):263-268. doi: 10.1111/bjh.16851. Epub 2020 Jun 8.

  PMID: 32510635 BACKGROUND

• Gonzalez EG, Casanova MA, Samarkanova D, Aldecoa-Bilbao V, Teresa-Palacio M, Busquets EF, Figueras-Aloy J, Salvia-Roiges M, Querol S. Feasibility of umbilical cord blood as a source of red blood cell transfusion in preterm infants. Blood Transfus. 2021 Nov;19(6):510-517. doi: 10.2450/2020.0169-20. Epub 2020 Dec 18.

  PMID: 33370228 BACKGROUND

MeSH Terms

Conditions

Anemia, Neonatal; beta-Thalassemia; Bronchopulmonary Dysplasia; Retinopathy of Prematurity; Perinatal Death

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Genetic Diseases, Inborn; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Retinal Diseases; Eye Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Miguel Maria Alsina Casanova, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Dinara Smarkanova, MD

  Banc de Sang i Teixits

  STUDY DIRECTOR

• Miguel Ramón Jiménez, MD

  Hospital Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

• Fátima Camba Longueira, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

• María José García Borau, MD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

• Marta Ocaña Rico, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

• Mònica Domingo Puiggròs, MD

  Hospital Parc Taulí

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Maria Alsina Casanova, MD

CONTACT

+34932275600; mmalsina@clinic.cat

Dinara Smarkanova, MD

CONTACT

+34935573500; dsamarkanova@bst.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Extremely preterm infants who require a red blood cell transfusion will be randomly assigned in a 1:1 ratio to receive either cord blood-derived red blood cell concentrates (CB-RBC) or standard adult donor red blood cell transfusions. Transfusions will only be administered when clinically indicated according to standard neonatal transfusion guidelines. If cord blood units are not available at the time of transfusion, compatible adult donor blood will be used.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 31, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 31, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)