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

Retinopathy of Prematurity Clinical Trial

— BORN  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100212
• Other study ID #: 4364
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Luciana Teofili, MD
• Phone: 0630154373
• Email: luciana.teofili[@]unicatt.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 27 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

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).
• adult donor RBC concentrates
Patients in the comparator arm are candidates to receive adult donor-RBC units

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Careggi	Firenze
Italy	Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo,	Foggia
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan
Italy	Ospedale Evangelico Villa Betania	Naples
Italy	AORN Santobono-Pausilipon	Napoli
Italy	Fondazione IRCCS Policlinico S. Matteo	Pavia
Italy	Azienda Sanitaria Locale- Presidio Ospedaliero di Pescara	Pescara
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Azienda Ospedaliera Bianchi Melacrino Morelli	Reggio Calabria
Italy	Fondazione Policlinico Universitario A.Gemelli IRCCS	Rome
Italy	Città della Salute e della Scienza	Torino

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Fresenius Hemocare

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinopathy of prematurity	Incidence of severe ROP (stage 3 and higher) in CB-RBC and A-RBC arms	up to the age of 40 weeks