Trial reportTrials2022
BORN study: a multicenter randomized trial investigating cord blood red blood cell transfusions to reduce the severity of retinopathy of prematurity in extremely low gestational age neonates.
Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05100212 (Umbilical or Adult Donor Red Blood Cells to Transfuse Extremely Low Gestational Age Neonates. A Randomized Trial to Assess the Effect on Retinopathy of Prematurity Severity.), which is not on this map. Cited by 20 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Umbilical or Adult Donor Red Blood Cells to Transfuse Extremely Low Gestational Age Neonates. A Randomized Trial to Assess the Effect on Retinopathy of Prematurity Severity.
Who cites it
20 citing papers in PubMed, 36 citations in OpenAlex.
- 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.Italian journal of pediatrics · 2024Trial
- Differences in Cerebral Tissue Oxygenation in Preterm Neonates Receiving Adult or Cord Blood Red Blood Cell Transfusions.JAMA network open · 2023Trial
- Cord blood red cell concentrates for preterm neonate transfusion: Insights from the multicenter BORN trial.Transfusion · 2026Article
- Rheological and biochemical comparison of cord and adult blood red cells for transfusion applications.Scientific reports · 2026Article
- Application of Umbilical Cord Blood for the Clinical Prevention and Treatment of Complications in Preterm Infants(Review).Stem cell reviews and reports · 2026Review
- Three studies needed to inform the design of the U-BET (umbilical cord blood for extremely low-gestational-age transfusions) clinical trial.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- The oxygen paradox in retinopathy of prematurity: could fetal hemoglobin be the key?Frontiers in pediatrics · 2026Article
- Involving neonatal hematology and transfusion medicine in global efforts to eliminate severe retinopathy of prematurity.Journal of perinatology : official journal of the California Perinatal Association · 2025Review
- Review of Retinopathy of Prematurity Management in the Anti-VEGF Era: Evolving Global Paradigms, Persistent Challenges and Our AI-Assisted Future.Clinical & experimental ophthalmology · 2025Review
- Large-Scale Production of Transfusion-Ready Red Blood Cells From Induced Pluripotent Stem Cells.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Cord red blood cell transfusions for severe retinopathy in preterm neonates in Italy: a multicenter randomized controlled trial.EClinicalMedicine · 2025Article
- Association between hematocrit in the first two hours of life and retinopathy during prematurity: a retrospective study from DRYAD.BMC pediatrics · 2025Observational
- The number of blood transfusions received and the incidence and severity of chronic lung disease among NICU patients born >31 weeks gestation.Journal of perinatology : official journal of the California Perinatal Association · 2025Article
- Fetal Hemoglobin as a Predictive Biomarker for Retinopathy of Prematurity: A Prospective Multicenter Cohort Study in Portugal.Biomedicines · 2025Article
- Review
- Retinopathy of Prematurity in Eight Portuguese Neonatal Intensive Care Units: Incidence, Risk Factors, and Progression-A Prospective Multicenter Study.Children (Basel, Switzerland) · 2024Article
- Banked term umbilical cord blood to meet the packed red blood cell transfusion needs of extremely-low-gestational-age neonates: a feasibility analysis.Journal of perinatology : official journal of the California Perinatal Association · 2024Article
- Hyperferritinemia among very-low-birthweight infants in Thailand: a prospective cohort study.Journal of perinatology : official journal of the California Perinatal Association · 2024Article
- ROP: 80 Years after Its Detection - Where Do We Stand and How Long Will We Continue to Laser?Neonatology · 2024Review
- Modifiable Risk Factors and Preventative Strategies for Severe Retinopathy of Prematurity.Life (Basel, Switzerland) · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
27 authors at 11 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundExtremely low gestational age neonates (ELGANs, i.e., neonates born before 28 weeks of gestation) are at high risk of developing retinopathy of prematurity (ROP), with potential long-life visual impairment. Due to concomitant anemia, ELGANs need repeated red blood cell (RBC) transfusions. These produce a progressive replacement of fetal hemoglobin (HbF) by adult hemoglobin (HbA). Furthermore, a close association exists between low levels of HbF and severe ROP, suggesting that a perturbation of the HbF-mediated oxygen release may derange retinal angiogenesis and promote ROP. METHODS/
designBORN (umBilical blOod to tRansfuse preterm Neonates) is a multicenter double-blinded randomized controlled trial in ELGANs, to assess the effect of allogeneic cord blood RBC transfusions (CB-RBCs) on severe ROP development. Recruitment, consent, and randomization take place at 10 neonatology intensive care units (NICUs) of 8 Italian tertiary hospitals. ELGANs with gestational age at birth comprised between 24+0 and 27+6 weeks are randomly allocated into two groups: (1) standard RBC transfusions (adult-RBCs) (control arm) and (2) CB-RBCs (intervention arm). In case of transfusion need, enrolled patients receive transfusions according to the allocation arm, unless an ABO/RhD CB-RBC is unavailable. Nine Italian public CB banks cooperate to make available a suitable amount of CB-RBC units for all participating NICUs. The primary outcome is the incidence of severe ROP (stage 3 or higher) at discharge or 40 weeks of postmenstrual age, which occurs first. DISCUSSION: BORN is a groundbreaking trial, pioneering a new transfusion approach dedicated to ELGANs at high risk for severe ROP. In previous non-randomized trials, this transfusion approach was proven feasible and able to prevent the HbF decrease in patients requiring multiple transfusions. Should the BORN trial confirm the efficacy of CB-RBCs in reducing ROP severity, this transfusion strategy would become the preferential blood product to be used in severely preterm neonates.
trial registrationClinicalTrials.gov NCT05100212. Registered on October 29, 2021.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.