Extremely Premature InfantNCT07502781
Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm Infants
A study testing Cord Blood Red Blood Cells and Standard Adult Donor Red Blood Cells in people with Extremely Premature Infant and Anemia Neonatal, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 28 weeks
- Conditions the study is for
- Extremely Premature Infant, Anemia Neonatal, Blood Transfusion
- What is being tested?
- Cord Blood Red Blood Cells and Standard Adult Donor Red Blood Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2027to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Clínic de Barcelona - Maternitat
Barcelona, 08028
Miguel Maria Alsina Casanova, MD, +34932275600 ext. 7447, mmalsina@clinic.cat
Miguel Ramón Jimenez, MD
About this study
Official title: Multicenter, Randomized, Double-Blind Pilot Clinical Trial Evaluating the Impact of Transfusion With Heterologous Cord Blood-Derived Red Blood Cells Versus Adult Red Blood Cells in Extremely Premature Infants
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.
Read more
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.
Read the detailed description
Neonatal anemia is a common condition in extremely preterm infants (born before 28 weeks of gestation) and is associated with significant health risks. Despite the implementation of evidence-based strategies to reduce anemia, such as delayed umbilical cord clamping and cord milking, many extremely preterm infants still require red blood cell transfusions during the first weeks of life due to a multifactorial decline in hemoglobin levels.
Currently, red blood cell transfusions for these infants use blood from adult donors. Transfusion of adult donor blood has been associated with complications linked to fluctuations in tissue oxygen levels, including retinopathy of prematurity and bronchopulmonary dysplasia. One key factor contributing to these complications is the lower proportion of fetal hemoglobin (HbF) in adult donor blood compared to the infant's natural blood. HbF has a higher affinity for oxygen and releases oxygen more slowly, whereas adult hemoglobin (HbA) delivers oxygen more rapidly to tissues, increasing the risk of oxygen toxicity. Additionally, adult donor blood may contain trace amounts of heavy metals, which could potentially affect extremely preterm infants, although this has not been formally studied.
Red blood cell concentrates derived from umbilical cord blood (CB-RBC) provide an alternative that is closer to the infant's own blood composition. CB-RBC transfusions contain higher levels of HbF, which may reduce tissue oxygen stress. Pilot studies in our center have shown that CB-RBC transfusions are feasible, safe, and effective. In one preliminary study, ten extremely preterm infants (<28 weeks gestation) received a total of 23 CB-RBC transfusions without adverse reactions, indicating that this approach is safe in clinical practice. However, medium- and long-term benefits of CB-RBC transfusions remain unclear.
Recent research shows that higher HbF levels are inversely correlated with morbidities related to tissue hyperoxygenation, such as bronchopulmonary dysplasia and retinopathy of prematurity. Studies in Italy, including those by Teofili et al., have shown encouraging trends toward reducing severe retinopathy, although small sample sizes prevented statistical significance. These findings support the need for a larger randomized multicenter trial to evaluate clinical outcomes more conclusively.
This study is a randomized multicenter clinical trial coordinated among all major level 3A and 3B public neonatal units in the Barcelona area, with unanimous support from participating units. Approximately 115 extremely preterm infants will be enrolled. Eligible infants will be randomly assigned to receive either CB-RBC transfusions or standard adult donor red blood cell transfusions if a transfusion is clinically indicated. Transfusions will only be performed when medically necessary. If cord blood is not available at the time of transfusion, compatible adult donor blood will be used regardless of assigned group.
To assess the effects of transfusion, small blood samples will be collected at birth, at one month of age, and 24 hours after any transfusion. Blood collection follows routine clinical practice, and volumes are minimal (~0.2 mL per sample). Non-invasive sensors will be placed on the infant's head for 24 hours to monitor cerebral oxygenation. Urine samples will also be collected before and after transfusion to evaluate tissue oxygen delivery. All procedures are designed to minimize risk and discomfort for participants.
Study Hypothesis: We hypothesize that transfusion with cord blood red blood cell concentrates will reduce the combined outcome of bronchopulmonary dysplasia, retinopathy of prematurity, and death before 36 weeks postmenstrual age or hospital discharge (whichever occurs first), compared to transfusions with standard adult donor red blood cells.
The results of this study aim to provide strong evidence regarding the clinical benefits of CB-RBC transfusions in extremely preterm infants, including the potential to reduce transfusion-related complications and improve outcomes. If successful, this approach could be implemented more widely to enhance neonatal care for this vulnerable population
- Conditions
- Extremely Premature Infant, Anemia Neonatal, Blood Transfusion, Umbilical Cord Blood, Fetal Hemoglobin, Bronchopulmonary Dysplasia (BPD)
- Being tested
- Cord Blood Red Blood Cells, Standard Adult Donor Red Blood Cells
- 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
- Medical subject headings
- Anemia, Neonatal, beta-Thalassemia, Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord Blood Red Blood CellsBiological
Also called CH-SCU
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.
Standard Adult Donor Red Blood CellsBiological
Also called CH-SA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Standard Adult Donor Red Blood Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At one month of life.
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.
Measured: Up to 90 days after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Extremely Premature InfantStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, Hospital de la Santa creu i Sant Pau - Barcelona, Hospital Vall d'Hebron, Germans Trias i Pujol Hospital, Parc Taulí Hospital Universitari
- Responsible party
- Sponsor
- Investigators
- Miguel Maria Alsina Casanova, MD, Principal investigator, Hospital Clinic of BarcelonaDinara Smarkanova, MD, Study director, Banc de Sang i TeixitsMiguel Ramón Jiménez, MD, Principal investigator, Hospital Sant Joan de DeuFátima Camba Longueira, MD, Principal investigator, Hospital Vall d'HebronMaría José García Borau, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauMarta Ocaña Rico, MD, Principal investigator, Germans Trias i Pujol HospitalMònica Domingo Puiggròs, MD, Principal investigator, Hospital Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502781
- Sponsor's protocol ID
- CBLOOD - PE 01
- Status last verified
- May 2025
- First submitted
- 16 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37900679Teofili 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.
PubMed 39113069Teofili 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.
PubMed 32510635Gonzalez 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.
PubMed 33370228
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind Pilot Clinical Trial Evaluating the Impact of Transfusion With Heterologous Cord Blood-Derived Red Blood Cells Versus Adult Red Blood Cells in Extremely Premature Infants
- ClinicalTrials.gov ID
- NCT07502781
- Acronym / sponsor ID
- CBLOOD - PE 01
- Conditions
- Extremely Premature Infant, Anemia Neonatal, Blood Transfusion, Umbilical Cord Blood, Fetal Hemoglobin, Bronchopulmonary Dysplasia (BPD)
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, Hospital de la Santa creu i Sant Pau - Barcelona, Hospital Vall d'Hebron, Germans Trias i Pujol Hospital, Parc Taulí Hospital Universitari
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neonatal anemia is a common condition in extremely preterm infants (born before 28 weeks of gestation) and is associated with significant health risks. Despite the implementation of evidence-based strategies to reduce anemia, such as delayed umbilical cord clamping and cord milking, many extremely preterm infants still require red blood cell transfusions during the first weeks of life due to a multifactorial decline in hemoglobin levels.
Currently, red blood cell transfusions for these infants use blood from adult donors. Transfusion of adult donor blood has been associated with complications linked to fluctuations in tissue oxygen levels, including retinopathy of prematurity and bronchopulmonary dysplasia. One key factor contributing to these complications is the lower proportion of fetal hemoglobin (HbF) in adult donor blood compared to the infant's natural blood. HbF has a higher affinity for oxygen and releases oxygen more slowly, whereas adult hemoglobin (HbA) delivers oxygen more rapidly to tissues, increasing the risk of oxygen toxicity. Additionally, adult donor blood may contain trace amounts of heavy metals, which could potentially affect extremely preterm infants, although this has not been formally studied.
Red blood cell concentrates derived from umbilical cord blood (CB-RBC) provide an alternative that is closer to the infant's own blood composition. CB-RBC transfusions contain higher levels of HbF, which may reduce tissue oxygen stress. Pilot studies in our center have shown that CB-RBC transfusions are feasible, safe, and effective. In one preliminary study, ten extremely preterm infants (<28 weeks gestation) received a total of 23 CB-RBC transfusions without adverse reactions, indicating that this approach is safe in clinical practice. However, medium- and long-term benefits of CB-RBC transfusions remain unclear.
Recent research shows that higher HbF levels are inversely correlated with morbidities related to tissue hyperoxygenation, such as bronchopulmonary dysplasia and retinopathy of prematurity. Studies in Italy, including those by Teofili et al., have shown encouraging trends toward reducing severe retinopathy, although small sample sizes prevented statistical significance. These findings support the need for a larger randomized multicenter trial to evaluate clinical outcomes more conclusively.
This study is a randomized multicenter clinical trial coordinated among all major level 3A and 3B public neonatal units in the Barcelona area, with unanimous support from participating units. Approximately 115 extremely preterm infants will be enrolled. Eligible infants will be randomly assigned to receive either CB-RBC transfusions or standard adult donor red blood cell transfusions if a transfusion is clinically indicated. Transfusions will only be performed when medically necessary. If cord blood is not available at the time of transfusion, compatible adult donor blood will be used regardless of assigned group.
To assess the effects of transfusion, small blood samples will be collected at birth, at one month of age, and 24 hours after any transfusion. Blood collection follows routine clinical practice, and volumes are minimal (~0.2 mL per sample). Non-invasive sensors will be placed on the infant's head for 24 hours to monitor cerebral oxygenation. Urine samples will also be collected before and after transfusion to evaluate tissue oxygen delivery. All procedures are designed to minimize risk and discomfort for participants.
Study Hypothesis: We hypothesize that transfusion with cord blood red blood cell concentrates will reduce the combined outcome of bronchopulmonary dysplasia, retinopathy of prematurity, and death before 36 weeks postmenstrual age or hospital discharge (whichever occurs first), compared to transfusions with standard adult donor red blood cells.
The results of this study aim to provide strong evidence regarding the clinical benefits of CB-RBC transfusions in extremely preterm infants, including the potential to reduce transfusion-related complications and improve outcomes. If successful, this approach could be implemented more widely to enhance neonatal care for this vulnerable population
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cord Blood-Derived Red Blood Cell Transfusion | Experimental | Biological: Cord Blood Red Blood CellsExtremely 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. |
| Adult Donor Red Blood Cell Transfusion | Active comparator | Biological: Standard Adult Donor Red Blood CellsExtremely 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. |
Who may qualify
- Ages
- 23 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Prior red blood cell transfusion during the fetal or neonatal period.
- Maternal-fetal immunization (e.g., isoimmunization).
- Fetal hydrops.
- Major congenital malformations.
- Congenital infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cord Blood Red Blood CellsAlso: CH-SCUNeonates 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. | Biological | Cord Blood-Derived Red Blood Cell Transfusion |
| Standard Adult Donor Red Blood CellsAlso: CH-SANeonates 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. | Biological | Adult Donor Red Blood Cell Transfusion |
Primary outcome
Composite outcome of bronchopulmonary dysplasia, retinopathy of prematurity, or death in extremely prematurs
Time frame: From birth until 36 weeks postmenstrual age or hospital discharge (whichever occurs first).
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.
2 secondary outcomes
Fetal hemoglobin (HbF) threshold at one month associated with clinical outcomes
Time frame: At one month of life.
Oxygen-free days within 90 days post-randomization
Time frame: Up to 90 days after randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 37900679Torrejon-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.
- Background: PubMed 39113069Teofili 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.
- Background: PubMed 32510635Teofili 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.
- Background: PubMed 33370228Gonzalez 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.
- Individual participant dataSharing planned: No
Related trials for Extremely Premature Infant
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
RecruitingObservational study
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Late-Onset Neonatal Sepsis, Extreme Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miguel Maria Alsina Casanova, MD principal investigator
Hospital Clinic of Barcelona
Dinara Smarkanova, MD study director
Banc de Sang i Teixits
Miguel Ramón Jiménez, MD principal investigator
Hospital Sant Joan de Deu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cord Blood Red Blood Cells and Standard Adult Donor Red Blood Cells in people with Extremely Premature Infant and Anemia Neonatal, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miguel Maria Alsina Casanova, MD (+34932275600 ext. 7503, mmalsina@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of bronchopulmonary dysplasia, retinopathy of prematurity, or death in extremely prematurs (time frame: From birth until 36 weeks postmenstrual age or hospital discharge (whichever occurs first).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07502781, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.