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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different methods of protein delivery affect nutrition in critically ill children. Researchers compare continuous protein delivery, which is steady, with bolus protein delivery, administered in doses throughout the day. The goal is to determine which method better supports weight and muscle maintenance in children staying in the pediatric intensive care unit (PICU). Suitable candidates for this trial are children aged 1-11 who are in the PICU and receiving nutrition through a feeding tube. As an unphased trial, this study provides a unique opportunity to enhance understanding of the best nutritional support for critically ill children.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both continuous and bolus protein delivery methods are generally safe for critically ill children. Studies have found that providing more than 60% of the recommended protein intake can reduce the risk of death in children on ventilators. This finding suggests that adequate protein intake is important and safe for recovery.

For bolus protein delivery, research indicates that this method can improve protein levels in the blood. One study found that administering protein at a rate of 2.2 grams per kilogram per day is usually safe. However, excessive protein might not be beneficial and could be harmful, especially for children with kidney problems.

Overall, both methods appear well-tolerated in critically ill children, with research supporting their safety and potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for critically ill children because they explore different ways to deliver dietary protein, which is crucial for recovery. The continuous protein delivery method stands out as it provides a steady supply of protein mixed into the enteral formula around the clock, aiming to ensure consistent nutrition without interruption. On the other hand, the bolus protein method is distinctive because it delivers protein in concentrated doses every four hours through a syringe, potentially enhancing protein absorption and utilization in conjunction with standard feeding. Understanding which method optimizes protein intake could significantly improve nutritional support and outcomes for critically ill young patients.

What evidence suggests that this trial's protein delivery methods could be effective for critically ill children?

Research has shown that proper nutrition for very sick children can reduce their risk of complications or death. Studies have found that high-protein nutrition aids recovery in these young patients. In this trial, participants will join either the continuous protein arm or the bolus protein arm. Continuous protein provision and rapid achievement of nutrition goals are linked to lower mortality rates. Conversely, providing protein in larger amounts at set times, known as bolus feeding, can better meet daily protein needs. Both methods aim to prevent muscle loss and aid recovery, but bolus feeding might be more effective at maintaining muscle strength and health. ^{1 2 3 6 7}

Who Is on the Research Team?

Rajavel Elango, PhD

Principal Investigator

University of British Columbia, Department of Pediatrics

Are You a Good Fit for This Trial?

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

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

Citations

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Thus, higher protein doses do not improve patient outcomes and may increase mortality in those patients with AKI, while low protein doses ...