Inflammation and Cerebral Oxygenation in Preterm Newborns Following Fetal Red Blood Cell Transfusion Compared to Adult Red Blood Cell Transfusion

NCT ID: NCT06851390

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-14
• Study Completion Date: 2024-10-31

Brief Summary

Among diseases associated with premature birth, retinopathy of prematurity (ROP) is one of the most important causes of childhood blindness. ROP develops in the immature retina as a consequence of prolonged exposure to hyperoxia. A body of evidence suggests a connection between ROP and the number of red blood cell (RBC) transfusions. Moreover, in newborns receiving repeated transfusions, fetal hemoglobin (HbF) progressively declines. Our NICU participate to the BORN (umBilical blOod to tRansfuse preterm Neonates) trial, a double-blind, multi-center, randomized controlled trial with the aim of evaluating if preterm newborns randomized to receive cord blood (CB)-transfusions have a lower incidence of ROP, compared to newborns transfused with adult RBC cells. In the context of BORN trial, with this ancillary INCONTRA study, the investigators aim to explore the inflammatory burden, potentially impacting on development of the preterm newborn comorbidities, following CB-RBC transfusions, compared to adult RBC transfusions. to estimate the change in pro-inflammatory cytokine (IL-1β, IL-8, TNF-α) and MCP-1, MIF, s-ICAM levels levels circulating in preterm newborns before and after transfusion, Moreover, we want to monitor cerebral oxygenation and oxygenation delivery to the brain during and after the transfusion of the two different RBC products. Moreover, the investigators aim to monitor cerebral oxygenation and oxygenation delivery to the brain during and after the transfusion of the two different RBC products.

Conditions

Preterm Newborns

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

preterm newborns undergoing cord/placental RBC transfusion

No interventions assigned to this group

preterm newborns undergoing adult RBC transfusion

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• gestational age (GA) at birth < 28 weeks
• signed informed consent of parents.

Exclusion Criteria

• maternal-fetal immunization, hydrops fetalis
• major congenital malformations associated or not with genetic syndromes
• previous transfusions
• hemorrhage at birth requiring transfusion (within 12 hours from birth)
• congenital viral infections
• outborn infants who received RBC transfusions before admission to the Neonatal Intensive Care Units participating to the study
• health care team deeming it inappropriate to approach the infant's family for informed consent
• Severe IgA deficiency
• Any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 28 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Stefano Ghirardello

MD, Chief of Neonatal Unit and Neonatal Intensive care Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, , Italy

Countries

Italy

Other Identifiers

INCONTRA

Identifier Type: -

Identifier Source: org_study_id