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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06851390

Acronym

INCONTRA

Enrollment

Registered

2025-02-28

Start date

2024-05-14

Completion date

2024-10-31

Last updated

2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Newborns

Keywords

preterm newborn, packed RBC, 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

23 Weeks to 28 Weeks

Healthy volunteers

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.

Design outcomes

Primary

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

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

Countries

Italy

Outcome results