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 range

1 Year – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Nitrogen Balance

Timeframe: Nitrogen balance will be assessed both before and after 72 hours enteral feeding

I-FABP Levels

Timeframe: I-FABP levels will be assessed both before and after 72 hours enteral feeding

Trial details

NCT IDNCT06411873

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-10

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