Preterm NewbornsINCONTRANCT06851390
Inflammation and Cerebral Oxygenation in Preterm Newborns Following Fetal Red Blood Cell Transfusion Compared to Adult Red Blood Cell Transfusion
An observational study of Preterm Newborns, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 28 weeks
- Conditions the study is for
- Preterm Newborns
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 14 May 2024to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 28 weeks
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- gestational age (GA) at birth < 28 weeks
- signed informed consent of parents.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Keywords
- preterm newborn, packed RBC, inflammation markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| preterm newborns undergoing cord/placental RBC transfusion | Not described | |
| preterm newborns undergoing adult RBC transfusion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the first 4 months of life.
Secondary outcomes (1)
trend of cerebral rStO2, measured by near infrared spectroscopy (NIRS)
Measured: In the time of time of transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start14 May 2024
- Primary completion28 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm NewbornsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Ghirardello, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851390
- Sponsor's protocol ID
- INCONTRA
- Acronym
- INCONTRA
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision has not been made yet
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Cerebral Oxygenation in Preterm Newborns Following Fetal Red Blood Cell Transfusion Compared to Adult Red Blood Cell Transfusion
- ClinicalTrials.gov ID
- NCT06851390
- Acronym / sponsor ID
- INCONTRA / INCONTRA
- Conditions
- Preterm Newborns
- Keywords
- preterm newborn, packed RBC, inflammation markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preterm newborns undergoing cord/placental RBC transfusion | – | – |
| preterm newborns undergoing adult RBC transfusion | – | – |
Who may qualify
- Ages
- 23 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- gestational age (GA) at birth < 28 weeks
- signed informed consent of parents.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: During the first 4 months of life.
1 secondary outcome
trend of cerebral rStO2, measured by near infrared spectroscopy (NIRS)
Time frame: In the time of time of transfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided. A decision has not been made yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Newborns, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: During the first 4 months of life.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.