Splanchnic Oxygenation Response to Feeds in Preterm Neonates: Effect of Red Blood Cell Transfusion (NCT03643458) | Clinical Trial Compass
CompletedNot Applicable
Splanchnic Oxygenation Response to Feeds in Preterm Neonates: Effect of Red Blood Cell Transfusion
Italy20 participantsStarted 2013-06-01
Plain-language summary
Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor for necrotizing enterocolitis (NEC), which is one of the most severe gastrointestinal complications of prematurity.
Evidence from Doppler studies have shown a post-transfusion impairment of mesenteric blood flow in response to feeds, whereas NIRS studies have reported transient changes of splanchnic oxygenation after RBC transfusion; a possible role for these findings in increasing the risk for TANEC development has been hypothesized.
The aim of this study is to evaluate SrSO2 patterns in response to enteral feeding before and after transfusion.
Who can participate
Age range
1 Day – 3 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* gestational age \<32 weeks or birth weight \<1500 g
* need for red blood cell transfusion according to national guidelines
Exclusion Criteria:
* hemodynamic instability
* Prior occurrence of necrotizing or presence of symptoms and signs of feeding intolerance within one week before transfusion
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pre-transfusion splanchnic oxygenation pattern
Timeframe: Enteral feed before red blood cell transfusion administration (3 hours)
2
Post-transfusion splanchnic oxygenation pattern
Timeframe: Enteral feed after red blood cell transfusion administration (3 hours)
Trial details
NCT IDNCT03643458
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna