Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT02733718
Status:
UNKNOWN
Last Update Posted:
2016-04-11
First Post:
2016-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation
Sponsor:
Marmara University
Organization:
Study Overview
Official Title:
The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to compare the differences between three different feeding regimens on intestinal oxygenation during packed red blood cell (PRBC) transfusion in premature babies.
Detailed Description:
Necrotizing enterocolitis is an important cause of mortality and morbidity in neonates. Especially neonates, who are smaller than 32 weeks of gestational, need transfusions during their hospital stay. Recent evidences suggest a relation between antecedent PRBC transfusions and an increase in necrotizing enterocolitis (NEC). It has been reported that transfusion related NEC (TR-NEC) tend to occur immediately and up to 48 hours post-transfusion. Although the underlying mechanism of this relationship is still overinvestigation, altered oxygenation of the mesenteric vasculature during PRBC transfusion has been hypothesized to contribute to NEC development. But pathophysiology of this has not been cleared, yet. Nowadays, due to the increased risk of NEC during PRBC transfusion, different nutrition protocols are implemented in different units. These protocols contain permanent discontinuation, reducement or continuation of nutrition during the transfusion. As a result, there is still no evidence -based practice recommendation in this regard.
"Restricted Transfusion Guidelines" will be used for the decision of transfusion in premature infants. Patients will be divided into three different groups, according to their feeding regimen during transfusion.
Group 1: No enteral feeding before (two hours), during (3 hours) and after (two hours) red blood cell transfusion.
Group 2: Enteral feeding is reduced by %50 before, during and after the red blood cell transfusion.
Group 3: The same feeding volume will be continued without decreasing or stopping.
Groups will be determined with randomization. It was targeted to be at least twenty infants in each group. In all patients, mesenteric oxygenation will be compared before-during and after blood transfusion. Mesenteric oxygenation will be measured with Near Infrared Spectroscopy (NIRS), that is a non-invasive NIRS conducted technology. Cerebral oxygenation and peripheral oxygen saturations will be measured at the same timeline.
The investigators primary aim is to show the best method of feeding during transfusion that causes less feeding intolerance and NEC. The secondary outcomes will be the risk factors associated with feeding intolerance and NEC during PRBC transfusion, in premature babies.
"Restricted Transfusion Guidelines" will be used for the decision of transfusion in premature infants. Patients will be divided into three different groups, according to their feeding regimen during transfusion.
Group 1: No enteral feeding before (two hours), during (3 hours) and after (two hours) red blood cell transfusion.
Group 2: Enteral feeding is reduced by %50 before, during and after the red blood cell transfusion.
Group 3: The same feeding volume will be continued without decreasing or stopping.
Groups will be determined with randomization. It was targeted to be at least twenty infants in each group. In all patients, mesenteric oxygenation will be compared before-during and after blood transfusion. Mesenteric oxygenation will be measured with Near Infrared Spectroscopy (NIRS), that is a non-invasive NIRS conducted technology. Cerebral oxygenation and peripheral oxygen saturations will be measured at the same timeline.
The investigators primary aim is to show the best method of feeding during transfusion that causes less feeding intolerance and NEC. The secondary outcomes will be the risk factors associated with feeding intolerance and NEC during PRBC transfusion, in premature babies.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: