Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632314
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Impact of Enteral Feeding on Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in Preterm Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Enteral Feeding on Cerebral and Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in Preterm Infants a Prospective Randomized Controlled Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TANEC
Brief 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 andor necrotizing enterocolitis for 48 hours following the blood transfusion
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 andor necrotizing enterocolitis for 48 hours following the blood transfusion
Detailed Description:
Continuing enteral feeding during red blood cell transfusion can have a negative impact on cerebral and splanchnic oxygenation and trigger transfusion-related necrotizing enterocolitis TANEC in very low birth-weight infants of gestational age less than 32 weeks andor birthweight less than 1500 grams However the issue of continuing or withholding enteral feeding to prevent TANEC in these neonates is a matter of debate Enteral feeding is often withheld during blood transfusion to prevent TANEC
This study was carried out to investigate the effect of enteral feeding during red blood cell infusion on cerebral and splanchnic oxygenation in low-birth-weight preterm infants Secondary hypothesis was to observe if any the signs and symptoms of a new-onset feeding intolerance andor necrotizing enterocolitis for 48 hours following the blood transfusion
Enteral feeding will continue or be withhold in very low birthweight neonates during packed red blood cell transfusion Regional cerebral and splanchnic oxygenation were measured using near-infrared spectroscopy NIRS for 48 hours
This study was carried out to investigate the effect of enteral feeding during red blood cell infusion on cerebral and splanchnic oxygenation in low-birth-weight preterm infants Secondary hypothesis was to observe if any the signs and symptoms of a new-onset feeding intolerance andor necrotizing enterocolitis for 48 hours following the blood transfusion
Enteral feeding will continue or be withhold in very low birthweight neonates during packed red blood cell transfusion Regional cerebral and splanchnic oxygenation were measured using near-infrared spectroscopy NIRS for 48 hours
Study Oversight
Has Oversight DMC:
None
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?:
None