The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children

NCT06411873 | Completed DMC

• 1 other identifier: 24779
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteral Nutrition; Postoperative; Critically Ill Children

Keywords

Proteins; Enteral; Critically ill children; Postoperative

Outcome Measures

Primary Outcomes (2)

• Nitrogen Balance

  The Nitrogen Balance was calculated by subtracting nitrogen losses from the nitrogen intake, including urinary, faecal and miscellaneous losses (dermal, sweat, integumentary) with the following formula: Nitrogen Balance (mg/kg) = nitrogen intake (mg/kg) -(total urine nitrogen (mg/kg) + 75 mg/kg) where 75 mg/kg represents faecal and miscellaneous nitrogen losses. The total urinary nitrogen (TUN) excretion was estimated as the urinary urea nitrogen (UUN) concentration (mg/kg) × 1.25 to include nitrogen losses in the form of ammonia, creatinine, uric acid and amino acids. The UUN check from 24 hours urine sample.

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

• I-FABP Levels

  The blood samples for measuring I-FABP levels (pg/mL) will be securely transported to and processed at Prodia Laboratory.

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

Study Arms (2)

Control Group

PLACEBO COMPARATOR

The patients included in the control group received the customary protein amount and were fed a standard formula (Pediacomplete, Abbot, Indonesia)

Dietary Supplement: Control Group

Intervention Group

EXPERIMENTAL

The patients included in the intervention group received the same formula like control group with the addition of modular protein supplement PURO ISOPRO WPI Whey Isolate PLAIN, Puro Pure Nutrition, Sukoharjo, Indonesia (BPOM : MD 862312050010)

Dietary Supplement: Intervention Group

Interventions

Control Group DIETARY_SUPPLEMENT

Composition of formula per 100 mL : energy (100 kcal), protein (3 g), carbohydrate (13.54 g), lipids (3.93 g), protein energy ratio/PER 12%, osmolarity (310 mOsm/L), renal solute load/RSL (27.5 mOsm/100 kcal)

Control Group

Intervention Group DIETARY_SUPPLEMENT

Composition of formula per 100 mL : energy (105.5 kcal), protein (4.35 g), carbohydrate (13.54 g), lipids (3.93 g), protein energy ratio/PER 16.5%, osmolarity (333.5 mOsm/L), renal solute load/RSL (27.7 mOsm/100 kcal)

Intervention Group

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).
• Patients at high risk of refeeding syndrome according to ASPEN consensus
• Patients with acute or chronic kidney disorders.
• Patients with liver disorders.
• Patients with diabetes mellitus.
• Patients with inborn errors of metabolism.
• Patients receiving total parenteral nutrition.
• Patients requiring continuous life support devices such as continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO).
• Nitrogen balance cannot be measured (patients with drainage production \>1 ml/kg/hour or bleeding \>10% of total blood volume at the time of enteral nutrition initiation).

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects were recruited through consecutive sampling until the required number of participants was reached. They were then randomly assigned into study groups using block randomization. The randomization process was conducted online via https://www.sealedenvelope.com/, overseen by the methodology team. Results were stored securely, inaccessible to researchers. Allocation concealment was ensured with sequentially numbered sealed opaque envelopes, indicating standard or high-protein enteral nutrition. These were handed to a designated nutritionist coordinator, independent of the research team, responsible for storage, preparation, and distribution. Research assistants informed the coordinator of subjects, who then prepared the assigned nutrition accordingly. High-protein enteral nutrition resembled standard nutrition to maintain blindness. Researchers, patients, families, nurses, and physicians remained unaware of the nutrition type.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Indonesia University

Model Details: This trial is an interventional study with two arms. Participants will be randomised to high enteral protein or standard enteral protein. For both trial arms, participants will be provided with enteral nutrition (EN) as per standard of care.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 13, 2024
• Study Start: July 30, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 30, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

ID (1)