Impact of Enteral Feeding on Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in P… (NCT06632314) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impact of Enteral Feeding on Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in Preterm Infants
Turkey (Türkiye)45 participantsStarted 2021-06-01
Plain-language summary
This clinical trial aims to learn if enteral feeding influences cerebral and splanchnic oxygenation during red blood cell infusion in very low birth-weight preterm infants. It will also learn about how continuing or withholding enteral feeding during blood transfusion might trigger transfusion-related necrotizing enterocolitis. The main questions, it aims to answer are:
* Does continuing or withholding enteral feeding have any impact on splanchnic and cerebral oxygenation in very-low-birth-weight preterm infants?
* Does continuing enteral feeding result in feeding intolerance during red blood cell infusion or transfusion-related necrotizing enterocolitis (TANEC) in very-low-birth-weight preterm infants? Researchers will compare regional cerebral and splanchnic oxygenation obtained by Near Infra-Red Spectroscopy (NIRS) monitoring while receiving red blood cell transfusion.
Participants will:
* Continue or withhold enteral feeding during red blood cell infusion, and all participants will be under NIRS monitoring for the following 48 hours after the blood transfusion.
* Be monitored for any signs and symptoms of new-onset feeding intolerance and/or necrotizing enterocolitis for 48 hours following the blood transfusion
Who can participate
Age range
1 Day – 30 Days
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
. infants with gestational age ≤32 weeks and/or birthweight ≤1500 gr,
. survival at least the first week of life
. being able to tolerate a minimum total daily feeding volume of 100 mL/kg/day,
. hemodynamically stable infant (no need of inotropic support)
. receiving packed red blood cell transfusion for the treatment of anemia of prematurity
Exclusion criteria
. feeding intolerance
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
Splanchnic oxygenation
Timeframe: Prior to red blood cell transfusion to 48 hours following blood transfusion
2
Cerebral oxygenation
Timeframe: Prior to red blood cell transfusion to 48 hours following blood transfusion