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Protein Regimen

Dietary Protein Delivery for Critically Ill Children (PRO-KID Trial)

N/A

Recruiting

Led By Rajavel Elango, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving standard pediatric formula via NGT/OGT/GT

Children admitted to PICU over 1 year of age and younger than 11 years of life

Must not have

Admitted with home prescription for high dose steroids, receives growth hormone or insulin

Enteral nutrition is contraindicated or if nutrition requirements are partially/fully met by parenteral nutrition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up admission, 7 and 14 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how the delivery of dietary protein affects the nutrition status of critically ill children aged 1-11 years. The study will compare continuous versus bolus delivery of protein and measure markers

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves nutritional interventions rather than medications, side effects may be minimal but can include potential discomfort from frequent measurements and possible gastrointestinal issues due to different feeding regimens.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a condition like muscular dystrophy.

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I am receiving nutrition directly into my small intestine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ admission, 7 and 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~admission, 7 and 14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and admission, 7 and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mid-upper arm circumference

Secondary study objectives

Ultrasound of the Rectus Femoris Quadricep

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary protein

2009

N/A

~80

0 / 6Eligibility criteria met