Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319326
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-22
Brief Title:
Intestinal Perfusion After Feeding in Preterm and Term Infants
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Intestinal Perfusion After Feeding in Preterm and Term Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
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 is a pilot exploratory observational prospective cohort phase I study In this study we will gather preliminary data to evaluate i the magnitude of changes in blood flow in the bowel before and after feeding and ii the differences between preterm and term infants
Detailed Description:
Necrotizing enterocolitis NEC is the most devastating intestinal disease which remains a major unsolved clinical challenge in neonatology NEC is predominantly a disease of preterm or extremely preterm infants NEC results in high mortality neurodevelopmental impairment intestinal failure and reduced quality of life
Prematurity and enteral feeding are two of the most important risk factors for NEC More than 90 of infants with NEC have been enterally fed suggesting that feeding is an important priming step in making the intestine vulnerable to NEC Absorption of nutrients is energy-consuming and results in an increased oxygen demand after feeding followed by an increase in intestinal blood flow above baseline known as postprandial hyperemia Our preclinical studies have shown an intriguing discovery that prematurity is associated with a remarkably reduced intestinal response to feeding which predisposes the intestine to NEC
However there is lack of reliable clinical evidence to compare the magnitude of difference in postprandial intestinal blood flow in human preterm versus term infants If preterm infants do in fact demonstrate a diminished intestinal blood flow response to feeding this will shed light on the need for interventions in the feeding protocol of this vulnerable population to prevent the development of NEC
This study is a phase I exploratory prospective cohort study We will gather preliminary data to evaluate i the magnitude of changes in blood flow in the bowel before and after feeding and ii the differences between preterm and term infants
In a cohort of 20 patients 10 preterm 10 term we will evaluate feeding-related perfusion of the superior mesenteric artery and bowel wall immediately before and 60-minutes after feeding
Prematurity and enteral feeding are two of the most important risk factors for NEC More than 90 of infants with NEC have been enterally fed suggesting that feeding is an important priming step in making the intestine vulnerable to NEC Absorption of nutrients is energy-consuming and results in an increased oxygen demand after feeding followed by an increase in intestinal blood flow above baseline known as postprandial hyperemia Our preclinical studies have shown an intriguing discovery that prematurity is associated with a remarkably reduced intestinal response to feeding which predisposes the intestine to NEC
However there is lack of reliable clinical evidence to compare the magnitude of difference in postprandial intestinal blood flow in human preterm versus term infants If preterm infants do in fact demonstrate a diminished intestinal blood flow response to feeding this will shed light on the need for interventions in the feeding protocol of this vulnerable population to prevent the development of NEC
This study is a phase I exploratory prospective cohort study We will gather preliminary data to evaluate i the magnitude of changes in blood flow in the bowel before and after feeding and ii the differences between preterm and term infants
In a cohort of 20 patients 10 preterm 10 term we will evaluate feeding-related perfusion of the superior mesenteric artery and bowel wall immediately before and 60-minutes after feeding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None