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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Newborns

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo di Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Our NICU participate to the multicenter trial, BORN (umBilical blOod to tRansfuse preterm Neonates) enrolling newborns randomized to receive cord blood or adult transfusions. They were also evaluated in the present monocentric ancillary study (INCONTRA) to measure newborn's plasma concentration of inflammation markers

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
preterm newborns undergoing cord/placental RBC transfusion
preterm newborns undergoing adult RBC transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
measure of pro-inflammatory cytokine levels (IL-1β, IL-8, TNF-α) andMCP-1, MIF, s-ICAM levelscirculating in preterm newborns before transfusion and two hours after transfusion	During the first 4 months of life.

Secondary Outcome Measures

Outcome Measure	Time Frame
trend of cerebral rStO2, measured by near infrared spectroscopy (NIRS)	In the time of time of transfusion

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2024
• Primary Completion (Actual): October 28, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: inflammation markers; preterm newborn; packed RBC
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Inflammation
• Other Study ID Numbers: INCONTRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A decision has not been made yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No