NCT05100212 - umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN) | Biotech Hunter

Enrollment

146

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

January 15, 2025

Study Completion Date

January 15, 2025

Conditions

Retinopathy of Prematurity

Interventions

BIOLOGICAL

cord blood-RBC concentrates

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).

BIOLOGICAL

adult donor RBC concentrates

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

Trial Locations (10)

Unknown

Azienda Ospedaliero Universitaria Careggi, Florence

Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo,, Foggia

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

Ospedale Evangelico Villa Betania, Naples

AORN Santobono-Pausilipon, Napoli

Fondazione IRCCS Policlinico S. Matteo, Pavia

Azienda Ospedaliero Universitaria Pisana, Pisa

Azienda Ospedaliera Bianchi Melacrino Morelli, Reggio Calabria

Città della Salute e della Scienza, Torino

00168

Fondazione Policlinico Universitario A.Gemelli IRCCS, Rome