Dietary Protein Delivery for Critically Ill Children

(PRO-KID Trial)

Overseen By Rajavel Elango, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: High dose steroids, Growth hormone, Insulin

Disqualifiers: Neuromuscular conditions, Parenteral nutrition, Specialized diet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

96 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on high dose steroids, growth hormone, or insulin, you cannot participate in the trial.

What data supports the effectiveness of the treatment Continuous Vs Bolus Protein Delivery for critically ill children?

Research suggests that providing more protein to critically ill patients, including children, is important because it can help prevent muscle wasting and improve recovery. However, the best way to deliver this protein, whether continuously or in separate doses (bolus), is still being studied, and there is no clear evidence yet on which method is more effective. ^{1 2 3 4 5}

Is protein delivery safe for critically ill children?

The research does not provide specific safety data for protein delivery in critically ill children, but it highlights the ongoing debate and need for more evidence on the best ways to provide protein in these patients. ^{1 3 4 5 6}

How does the treatment of continuous vs bolus protein delivery differ from other treatments for critically ill children?

This treatment is unique because it compares two methods of protein delivery—continuous (steady, ongoing supply) versus bolus (larger amounts given at intervals)—to optimize protein intake in critically ill children, which is crucial for preventing muscle wasting and improving recovery outcomes. ^{1 2 3 5 6}

What is the purpose of this trial?

The goal of this intervention study is to evaluate the difference in nutrition status markers (weight and muscle mass) when giving dietary protein by continuous or bolus delivery in critically ill children ages 1-11y. The main questions it aims to answer are: Primary: Bolus protein delivery will lessen the decline in mid-upper arm circumference (MUAC) z-score by 0.5 standard deviation in critically ill children aged 1-11y after 1wk. Ultrasound will correlate to MUAC. Secondary: Bolus protein delivery will provide more (grams per day) than when provided continuously, therefore it is more likely to meet the minimum estimated needs. Participants will have daily nutrition intake data collected, and undergo body composition measures (weight, MUAC and ultrasound of the upper thigh muscle) at day of enrollment, and MUAC/Ultrasound on follow up days 3, 5, 7 and 14 after the intervention started.

Research Team

Rajavel Elango, PhD

Principal Investigator

University of British Columbia, Department of Pediatrics

Eligibility Criteria

This trial is for critically ill children aged 1-11 years in the pediatric intensive care unit who require enteral nutrition therapy. The study excludes those with specific conditions that could interfere with the intervention or measurement of outcomes.

Inclusion Criteria

Expected to remain in the pediatric intensive care unit for longer than 72 hours

I am currently being fed through a tube with standard pediatric formula.

My child is between 1 and 10 years old and in the PICU.

Exclusion Criteria

I take high dose steroids, growth hormone, or insulin at home.

Patients with a cow's milk protein allergy cannot safely receive a whey-based protein supplement

I cannot eat by mouth and get some or all my nutrition through IV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Daily screening

Intervention

Participants receive either continuous or bolus protein delivery as part of their enteral nutrition

14 days

Daily monitoring and data collection

Follow-up

Participants are monitored for changes in mid-upper arm circumference and muscle mass

14 days

Assessments on days 3, 5, 7, and 14

Treatment Details

Interventions

• Continuous Vs Bolus Protein

Trial Overview The study tests whether giving dietary protein in a single large dose (bolus) versus continuously throughout the day affects weight and muscle mass differently in sick kids. It measures body changes over two weeks using arm circumference and thigh muscle ultrasound.

Participant Groups

Group I: Bolus protein Experimental Treatment 1 Intervention

Bolus protein arm will provide protein powder mixed with water every 4h through syringe. This will be in addition to continuous enteral formula feeding which remains standard of care.

Group II: Continuous protein Active Control 1 Intervention

Continuous protein arm will have dietary protein supplement mixed into the enteral formula product to be provided around the clock without break.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Findings from Research

Optimal protein delivery in critically ill patients is challenging due to varying international guidelines and a lack of high-quality evidence, with most studies being observational and showing limited effects on mortality and muscle function.

While adequate protein intake is important, current research indicates that high protein delivery often falls short of recommendations, and there is no strong evidence supporting the need for specific amino acid supplementation in ICU patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein supplementation in critical illness: why, when and how? Bels, JLM., Ali Abdelhamid, Y., van de Poll, MCG.[2023]

In a pilot study involving 60 critically ill patients, a volume-target enteral nutrition protocol with protein supplementation significantly increased daily protein delivery (1.2 g/kg) compared to standard care (0.75 g/kg), leading to better nutritional support.

The intervention also reduced muscle loss, as indicated by a smaller decrease in quadriceps muscle layer thickness (0.22 cm less loss), and decreased the prevalence of malnutrition at ICU discharge (7% vs 28%), without affecting mortality or length of hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Full Energy and Protein Delivery in Critically Ill Patients: A Pilot Randomized Controlled Trial (FEED Trial). Fetterplace, K., Deane, AM., Tierney, A., et al.[2019]

Critically ill patients experience significant muscle protein loss due to increased protein degradation, but they still retain the ability to absorb dietary protein and use it for muscle building, indicating potential for nutritional interventions.

Current research methods for studying protein absorption in critically ill patients are limited, and more sophisticated techniques are needed to better understand the extent of protein absorption and its benefits for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein absorption and kinetics in critical illness. Liebau, F., Deane, AM., Rooyackers, O.[2021]

In a study involving 51 critically ill children, a protein-enriched diet showed a positive trend in improving certain protein metabolism markers, particularly retinol-binding protein, compared to a standard diet.

The protein-enriched diet was found to be safe, with no adverse effects or hyperproteinemia reported, suggesting that standard diets may not provide adequate protein for critically ill children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral nutrition in the critically ill child: comparison of standard and protein-enriched diets. Botrán, M., López-Herce, J., Mencía, S., et al.[2013]

In a systematic review of 18 studies involving 2118 critically ill children, a total daily protein intake greater than 1.1 g/kg was linked to improved protein balance and reduced mortality rates.

Higher protein intake, particularly above 1.5 g/kg, showed even more significant benefits, although the optimal type of protein for enteral feeding remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the structure and dose of protein intake on clinical and metabolic outcomes in critically ill children: A systematic review. Hauschild, DB., Ventura, JC., Mehta, NM., et al.[2018]

Recent studies highlight the critical importance of protein and amino acid provision for improving outcomes in critically ill patients, although no randomized controlled trials have specifically tested different protein intake levels.

One observational study indicated that the benefits of protein intake on patient outcomes are influenced by energy intake, while another study in pediatric ICU patients suggested that postpyloric feeding and the involvement of a dedicated dietitian can enhance protein delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein delivery in critical illness. Weijs, PJ.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Protein supplementation in critical illness: why, when and how? [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Targeted Full Energy and Protein Delivery in Critically Ill Patients: A Pilot Randomized Controlled Trial (FEED Trial). [2019]

3. England pubmed.ncbi.nlm.nih.gov

Protein absorption and kinetics in critical illness. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Enteral nutrition in the critically ill child: comparison of standard and protein-enriched diets. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of the structure and dose of protein intake on clinical and metabolic outcomes in critically ill children: A systematic review. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Protein delivery in critical illness. [2018]