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

October 9, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Firenze, Italy
      • Foggia, Italy
        • Suspended
        • Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo,
      • Milan, Italy
      • Naples, Italy
        • Recruiting
        • Ospedale Evangelico Villa Betania
        • Contact:
          • Angelo Manna
      • Napoli, Italy
        • Recruiting
        • AORN Santobono-Pausilipon
        • Contact:
          • Roberta Penta De Vera D'Aragona
      • Pavia, Italy
        • Recruiting
        • Fondazione IRCCS Policlinico S. Matteo
        • Contact:
          • Stefano Ghirardello
      • Pescara, Italy
        • Not yet recruiting
        • Azienda Sanitaria Locale- Presidio Ospedaliero di Pescara
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tiziana Bonfini
        • Principal Investigator:
          • Eleonora Coclite
      • Pisa, Italy
      • Reggio Calabria, Italy
      • Rome, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A.Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Luciana Teofili
        • Contact:
        • Principal Investigator:
          • Patrizia Papacci
      • Torino, Italy
        • Recruiting
        • Città della Salute e della Scienza
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giulia Ansaldi
        • Principal Investigator:
          • Francesco Cresi
        • Principal Investigator:
          • Antonella Dragonetti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 6 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Adult-RBC transfusions
Adult-red blood cell concentrate transfusions
Biological: adult donor RBC concentrates
Patients in the comparator arm are candidates to receive adult donor-RBC units
Other Names:
  • adult donor packed RBC
Experimental: CB-RBC transfusions
Cord blood-red blood cell concentrate transfusions
Biological: cord blood-RBC concentrates
Patients in the experimental arm are candidates to receive CB-RBC units until the completion of 31 weeks of postmenstrual age (31+6). In case of unavailability of an ABO/Rh matched CB-RBC unit, patients receive adult -RBC (standard transfusions).
Other Names:
  • cord blood packed RBC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinopathy of prematurity
Time Frame: up to the age of 40 weeks
Incidence of severe ROP (stage 3 and higher) in CB-RBC and A-RBC arms
up to the age of 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Fresenius Hemocare

Investigators

  • Principal Investigator: Luciana Teofili, MD, Fondazione Policlinico Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4364

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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