The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children (NCT06411873) | Clinical Trial Compass
CompletedNot Applicable
The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children
Indonesia76 participantsStarted 2024-07-30
Plain-language 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.
Who can participate
Age range1 Year – 5 Years
SexALL
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Inclusion criteria
✓. Critically ill postoperative children (age 1 to 5 years of age)
✓. Hemodynamically stable within 48 hours postoperative
✓. The patient receives enteral nutrition within 48 hours postoperative
✓. The patient can undergo observation and examination for up to 72 hours after enteral nutrition therapy
✓. The parents/guardians are willing to participate in the study by signing the informed consent
Exclusion criteria
✕. Patients with absolute contraindications (paralytic/mechanical ileus, gastrointestinal obstruction, gastrointestinal perforation) or relative contraindications (gastrointestinal dysmotility, necrotizing enterocolitis, toxic megacolon, extensive peritonitis, gastrointestinal bleeding, gastrointestinal fistula) to enteral nutrition administration.
✕. Patients with a history of cow's milk allergy or using special formula milk.
✕. Patients still receiving breast milk (breastfeeding).
What they're measuring
1
Nitrogen Balance
Timeframe: Nitrogen balance will be assessed both before and after 72 hours enteral feeding
2
I-FABP Levels
Timeframe: I-FABP levels will be assessed both before and after 72 hours enteral feeding