Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411873
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-05-07
Brief Title:
The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children A Study of Nitrogen Balance and Intestinal Fatty Acid Binding Protein
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 o determine the feasibility and efficacy of high enteral protein in critically ill postoperative children It will also learn about the safety of high enteral protein for critically ill postoperative children The main questions it aims to answer are
Does high enteral protein improve nitrogen balance in critically ill postoperative children Does high enteral protein reduce levels of Intestinal Fatty Acid Binding Protein I-FABP in critically ill postoperative children
Researchers will compare high enteral protein to a standard enteral protein to see if high enteral protein works to improve nitrogen balance and reduces levels of Intestinal Fatty Acid Binding Protein I-FABP in critically ill postoperative children
Participants will
Take high enteral protein or standard enteral protein for 72 hours The nitrogen balance and I-FABP levels will be assessed both before and after enteral feeding
Monitoring and reporting of adverse events and serious adverse events will be conducted in accordance with good clinical practice guidelines
Does high enteral protein improve nitrogen balance in critically ill postoperative children Does high enteral protein reduce levels of Intestinal Fatty Acid Binding Protein I-FABP in critically ill postoperative children
Researchers will compare high enteral protein to a standard enteral protein to see if high enteral protein works to improve nitrogen balance and reduces levels of Intestinal Fatty Acid Binding Protein I-FABP in critically ill postoperative children
Participants will
Take high enteral protein or standard enteral protein for 72 hours The nitrogen balance and I-FABP levels will be assessed both before and after enteral feeding
Monitoring and reporting of adverse events and serious adverse events will be conducted in accordance with good clinical practice guidelines
Detailed Description:
Postoperative care in critically ill children often involves careful attention to nutritional support to optimize recovery and outcomes Among the various nutritional interventions high protein enteral nutrition has gained significant attention for its potential benefits in this population Adequate protein intake is essential for wound healing immune function and muscle preservation all of which are crucial aspects of recovery following surgery in critically ill children
High protein enteral nutrition offers a targeted approach to meet the increased protein requirements during the postoperative period By providing a concentrated source of protein directly into the gastrointestinal tract it bypasses potential barriers associated with oral intake and facilitates nutrient absorption in a controlled manner Additionally enteral nutrition is preferred over parenteral nutrition due to its lower risk of complications and potential to maintain gut integrity and function
Despite its theoretical advantages the clinical efficacy of high protein enteral nutrition in critically ill postoperative children remains an area of ongoing research Studies investigating its impact on nitrogen balance muscle protein synthesis immune function and clinical outcomes are essential for guiding nutritional practices in this vulnerable population
This study aim to evaluate the effect of high protein enteral nutrition on critically ill postoperative children with a focus on assessing nitrogen balance and intestinal fatty acid binding protein levels Through comprehensive analysis potential benefits and challenges associated with this nutritional intervention will be identified ultimately informing evidence-based nutritional strategies for optimizing postoperative care in critically ill pediatric patients
High protein enteral nutrition offers a targeted approach to meet the increased protein requirements during the postoperative period By providing a concentrated source of protein directly into the gastrointestinal tract it bypasses potential barriers associated with oral intake and facilitates nutrient absorption in a controlled manner Additionally enteral nutrition is preferred over parenteral nutrition due to its lower risk of complications and potential to maintain gut integrity and function
Despite its theoretical advantages the clinical efficacy of high protein enteral nutrition in critically ill postoperative children remains an area of ongoing research Studies investigating its impact on nitrogen balance muscle protein synthesis immune function and clinical outcomes are essential for guiding nutritional practices in this vulnerable population
This study aim to evaluate the effect of high protein enteral nutrition on critically ill postoperative children with a focus on assessing nitrogen balance and intestinal fatty acid binding protein levels Through comprehensive analysis potential benefits and challenges associated with this nutritional intervention will be identified ultimately informing evidence-based nutritional strategies for optimizing postoperative care in critically ill pediatric patients
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