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

NCT ID: NCT06411873

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-30

Study Completion Date

2024-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Enteral Nutrition Postoperative Critically Ill Children

Keywords

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Proteins Enteral Critically ill children Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Control Group

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

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type 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)

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)

Group Type EXPERIMENTAL

Intervention Group

Intervention Type 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)

Interventions

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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)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Dr. dr. Irene Yuniar, Sp.A(K)

Lecturer of Indonesia University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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24779

Identifier Type: -

Identifier Source: org_study_id