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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05100212
Collaborator
Fresenius Hemocare (Other)
146
Enrollment
8
Locations
2
Arms
24
Anticipated Duration (Months)
18.3
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: cord blood-RBC concentrates
  • Biological: adult donor RBC concentrates
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Interventional, randomized, controlled, double-blind, with an adaptive design to evaluate safety and efficacy of allogeneic CB-RBC transfusions.Interventional, randomized, controlled, double-blind, with an adaptive design to evaluate safety and efficacy of allogeneic CB-RBC transfusions.
Masking:
Single (Care Provider)
Primary Purpose:
Prevention
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.
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Retinopathy of prematurity [up to the age of 40 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Weeks to 27 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    • out-born infants

    • health care team deeming it inappropriate to approach the infant's family for informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Ospedaliero Universitaria Careggi Firenze Italy
    2 Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia Italy
    3 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy
    4 Azienda Sanitaria Locale- Presidio Ospedaliero di Pescara Pescara Italy
    5 Azienda Ospedaliero Universitaria Pisana Pisa Italy
    6 Azienda Ospedaliera Bianchi Melacrino Morelli Reggio Calabria Italy
    7 Fondazione Policlinico Universitario A.Gemelli IRCCS Rome Italy 00168
    8 Città della Salute e della Scienza Torino Italy

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Fresenius Hemocare

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05100212
    Other Study ID Numbers:
    • 4364
    First Posted:
    Oct 29, 2021
    Last Update Posted:
    Dec 7, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Retinal Diseases
    Retinopathy of Prematurity
    Premature Birth

    Study Results

    No Results Posted as of Dec 7, 2021