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NCT06851390: INCONTRA
Inflammation and Cerebral Oxygenation in Preterm Newborns Following Fetal Red Blood Cell Transfusion Compared to Adult Red Blood Cell Transfusion
trial in Preterm Newborns in 75 participants. Completed in 31 October 2024.
28 October 2024
Quick facts
| Lead sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 75 |
| Start date | 14 May 2024 |
| Primary completion | 28 October 2024 |
| Estimated completion | 31 October 2024 |
| Sites | 1 location across Italy |
Conditions studied
- Preterm Newborns — all drugs for Preterm Newborns →
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Who can join
Adults 23 Weeks to 28 Weeks, any sex, with Preterm Newborns. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06851390 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Policlinico San Matteo di Pavia
- Last refreshed: 5 March 2025
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