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

The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children: A Study of Nitrogen Balance and Intestinal Fatty Acid Binding Protein

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.

Study Overview

• Status: Completed
• Conditions: Enteral Nutrition; Postoperative; Critically Ill Children
• Intervention / Treatment: Dietary supplement: Control Group; Dietary supplement: Intervention Group

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • RSUPN Dr. Cipto Mangunkusumo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Critically ill postoperative children (age 1 to 5 years of age)
2. Hemodynamically stable within 48 hours postoperative
3. The patient receives enteral nutrition within 48 hours postoperative
4. The patient can undergo observation and examination for up to 72 hours after enteral nutrition therapy
5. The parents/guardians are willing to participate in the study by signing the informed consent

Exclusion Criteria:

1. 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.
2. Patients with a history of cow's milk allergy or using special formula milk.
3. Patients still receiving breast milk (breastfeeding).
4. Patients at high risk of refeeding syndrome according to ASPEN consensus
5. Patients with acute or chronic kidney disorders.
6. Patients with liver disorders.
7. Patients with diabetes mellitus.
8. Patients with inborn errors of metabolism.
9. Patients receiving total parenteral nutrition.
10. Patients requiring continuous life support devices such as continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO).
11. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; 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; 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)
Experimental: Intervention Group; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Actual): October 10, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative; Enteral; Proteins; Critically ill children
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 24779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No