Clinical trial NCT06851390: Inflammation and Cerebral Oxygenation in Preterm Newborns Following Fetal Red Blood Cell Transfusion Compared to Adult Red Blood Cell Transfusion
Official title: Inflammation and Cerebral Oxygenation in Preterm Newborns Following Fetal Red Blood Cell Transfusion Compared to Adult Red Blood Cell Transfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Newborns
Keywords: preterm newborn
packed RBC
inflammation markers
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 75
Sex: ALL
Minimum age (years): 23
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


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.

Primary outcomes:
measure: 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
timeFrame: During the first 4 months of life.
Secondary outcomes:
measure: trend of cerebral rStO2, measured by near infrared spectroscopy (NIRS)
timeFrame: In the time of time of transfusion
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
Study officials:
References: