Dietary Protein Delivery for Critically Ill Children
(PRO-KID Trial)
Recruiting in Palo Alto (17 mi)
Overseen byRajavel Elango, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Trial Summary
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.
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.
12345Is 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.
13456How 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.
12356Eligibility 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.
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Bolus proteinExperimental Treatment1 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 proteinActive Control1 Intervention
Continuous protein arm will have dietary protein supplement mixed into the enteral formula product to be provided around the clock without break.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
BC Childrens HospitalVancouver, Canada
Loading ...
Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
References
Protein supplementation in critical illness: why, when and how? [2023]In critically ill patients, optimal protein provision remains a challenge given the wide range in recommended protein delivery in international guidelines and the lack of robust, high quality evidence. As patients are confronted with poor functional outcomes after admission, often attributed to muscle wasting and persisting for multiple years, there is a pressing need for optimal nutritional strategies in the ICU, particularly including protein. This review will discuss the recent literature with regard to purpose, timing and mode of protein delivery.
Targeted Full Energy and Protein Delivery in Critically Ill Patients: A Pilot Randomized Controlled Trial (FEED Trial). [2019]International guidelines recommend greater protein delivery to critically ill patients than they currently receive. This pilot randomized clinical trial aimed to determine whether a volume-target enteral protocol with supplemental protein delivered greater amounts of protein and energy to critically ill patients compared with standard care.
Protein absorption and kinetics in critical illness. [2021]Timing, dose, and route of protein feeding in critically ill patients treated in an ICU is controversial. This is because of conflicting outcomes observed in randomized controlled trials (RCTs). This inconsistency between RCTs may occur as the physiology of protein metabolism and protein handling in the critically ill is substantially different from the healthy with limited mechanistic data to inform design of RCTs. This review will outline the current knowledge and gaps in the understanding of protein absorption and kinetics during critical illness.
Enteral nutrition in the critically ill child: comparison of standard and protein-enriched diets. [2013]To compare a standard diet and a protein-enriched diet in critically ill children.
Impact of the structure and dose of protein intake on clinical and metabolic outcomes in critically ill children: A systematic review. [2018]The aim of this study was to describe the effects of structure/type and total amount of protein intake on protein balance and clinical outcomes in critically ill children.
Protein delivery in critical illness. [2018]Protein delivery in the critically ill still is a highly debated issue. Here, we discuss only the most recent updates in the literature concerning protein nutrition of the critically ill.