AzTrials
AzTrials

Retinopathy of PrematurityPhase 2BORNNCT05100212

umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN)

A Phase 2 study testing cord blood-RBC concentrates and adult donor RBC concentrates in people with Retinopathy of Prematurity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 10 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Extremely low gestational age neonates (ELGAN, i.e., born before 28 gestation weeks) are among the most heavily transfused pediatric patients. In this clinical setting, repeated red blood cell (RBC) transfusions independently predict a poor outcome, with a higher risk for mortality and morbidity. Read more about this study

Who is it for?
Ages 24 to 27 weeks
Conditions the study is for
Retinopathy of Prematurity
What is being tested?
cord blood-RBC concentrates and adult donor RBC concentrates
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
10 sitesItaly
Study dates
1 Dec 2021to 15 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 24 to 27 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • gestational age (GA) at birth between 24+0 and 27+6 weeks
  • signed informed consent of parents.

Who cannot join

  • One or more of the following:
  • maternal-fetal immunization
  • hydrops fetalis
  • major congenital malformations associated or not with genetic syndromes
  • previous transfusions
  • hemorrhage at birth
  • congenital infections
  • health care team deeming it inappropriate to approach the infant's family for informed consent.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Italy10 sites

  • Azienda Ospedaliero Universitaria Careggi

    Florence

  • Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo,

    Foggia

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan

  • AORN Santobono-Pausilipon

    Naples

  • Ospedale Evangelico Villa Betania

    Naples

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia

  • Azienda Ospedaliero Universitaria Pisana

    Pisa

  • Azienda Ospedaliera Bianchi Melacrino Morelli

    Reggio Calabria

  • Fondazione Policlinico Universitario A.Gemelli IRCCS

    Rome, 00168

  • Città della Salute e della Scienza

    Torino

Other trials in Italy

About this study

Official title: 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.

Extremely low gestational age neonates (ELGAN, i.e., born before 28 gestation weeks) are among the most heavily transfused pediatric patients. In this clinical setting, repeated red blood cell (RBC) transfusions independently predict a poor outcome, with a higher risk for mortality and morbidity. Recent studies from our own and other groups highlighted a close association between low levels of fetal hemoglobin (HbF) and severity of retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD), two disabilities that frequently complicate preterm birth. This association is not surprising, considering that 1) preterm neonates have a highly immature antioxidant reserve and both ROP and BPD rely on the oxidative damage as underlying mechanism; 2) in comparison with HbA, HbF is endowed with higher oxygen affinity, greater redox potential, higher tetrameric stability, and higher ability to generate unbound nitric oxide, all functions potentially protective in presence of an oxidative challenge; 3) in normal prenatal life, developing organ and tissues are exposed exclusively to HbF until last weeks of gestation; 4) in preterm neonates, the switch of the synthesis from HbF to HbA occurs around their due date, i.e., several weeks after the premature birth; 5) when preterm neonates receive transfusions, their tissues are abruptly exposed to high levels of HbA. We have recently run a pilot trial demonstrating as a proof-of-concept that transfusing cord blood red blood cell concentrates (CB-RBC) effectively prevents or restrains the HbF loss consequent to adult donor standard transfusions (A-RBC). This study explores the hypothesis that transfusing CB-RBCs instead of A-RBC may lower the incidence of severe ROP in ELGANs needing transfusions.

Being tested
cord blood-RBC concentrates, adult donor RBC concentrates
Medical subject headings
Retinopathy of Prematurity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cord blood-RBC concentratesBiological

    Also called cord blood packed RBC

    Patients in the experimental arm are candidates to receive CB-RBC units until the completion of 29 weeks of postmenstrual age (29+6). In case of unavailability of an ABO/Rh matched CB-RBC unit, patients receive adult -RBC (standard transfusions).

  • adult donor RBC concentratesBiological

    Also called adult donor packed RBC

    Patients in the comparator arm are candidates to receive adult donor-RBC units

Study groups in NCT05100212
Study groupRoleWhat they receive
Adult-RBC transfusionsActive comparatorAdult-red blood cell concentrate transfusions
Receives: Biological: adult donor RBC concentrates
CB-RBC transfusionsExperimentalCord blood-red blood cell concentrate transfusions
Receives: Biological: cord blood-RBC concentrates

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retinopathy of prematurity

    Incidence of severe ROP (stage 3 and higher) in CB-RBC and A-RBC arms

    Measured: up to the age of 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2021
  2. Study start1 Dec 2021
  3. Primary completion15 Jan 2025
  4. Study completion15 Jan 2025

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Interventional, randomized, controlled, double-blind, with an adaptive design to evaluate safety and efficacy of allogeneic CB-RBC transfusions.
Masking
Single blind
Who is masked
Care provider
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05100212
Sponsor's protocol ID
4364
Acronym
BORN
Status last verified
Oct 2024
First submitted
14 Oct 2021
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39113069

  • Teofili L, Papacci P, Orlando N, Bianchi M, Pasciuto T, Mozzetta I, Palluzzi F, Giaco L, Giannantonio C, Remaschi G, Santosuosso M, Beccastrini E, Fabbri M, Valentini CG, Bonfini T, Cloclite E, Accorsi P, Dragonetti A, Cresi F, Ansaldi G, Raffaeli G, Villa S, Pucci G, Mondello I, Santodirocco M, Ghirardello S, Vento G. 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. Trials. 2022 Dec 13;23(1):1010. doi: 10.1186/s13063-022-06949-8.

    PubMed 36514106

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cord blood-RBC concentrates and adult donor RBC concentrates in people with Retinopathy of Prematurity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 10 sites in Italy.

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 2 inclusion and 8 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: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Italy. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retinopathy of prematurity (time frame: up to the age of 40 weeks). 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 NCT05100212, which also lists 2 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 27 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in