Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344286
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2024-03-12
Brief Title:
The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE
Sponsor:
Istanbul Training and Research Hospital
Organization:
Istanbul Training and Research Hospital
Study Overview
Official Title:
The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation Among Neonates With Hypoxic-ischemic Encephalopathy Under Therapeutic Hypothermia
Status:
COMPLETED
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:
The goal of this clinical trial is to evaluate the effects of minimal enteral nutrition MEN on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy NIRS during therapeutic hypothermia TH in babies with hypoxic ischemic encephalopathy The main question it aims to answer is
1- How do the mesenteric blood flow and oxygenation get affected with MEN during TH Participants will be either fed with MEN during TH or given placebo
1- How do the mesenteric blood flow and oxygenation get affected with MEN during TH Participants will be either fed with MEN during TH or given placebo
Detailed Description:
Objectives The investigators aimed to evaluate the effects of minimal enteral nutrition MEN on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy NIRS during therapeutic hypothermia TH in babies with HIE
Methods This prospective randomized controlled study was conducted between September 2020 to August 2022 The infants receiving MEN during hypothermia n 30 and those who were not fed n30 constituted the study and control groups Infants were monitored continuously with NIRS and mesenteric arterial blood flow velocities were measured with Doppler USG before and after feeding
Methods This prospective randomized controlled study was conducted between September 2020 to August 2022 The infants receiving MEN during hypothermia n 30 and those who were not fed n30 constituted the study and control groups Infants were monitored continuously with NIRS and mesenteric arterial blood flow velocities were measured with Doppler USG before and 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