Actively Recruiting

Phase Not Applicable
Age: 1Year - 11Years
All Genders
ID06721923

Continuous Versus Bolus Dietary Protein and Nutrition Status in the Pediatric Intensive Care Unit: Pilot Study

Led by University of British Columbia · Updated on 2026-02-12

96

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how different ways of giving dietary protein affect nutrition markers like weight and muscle mass in critically ill children aged 1 to 11 years. The study aims to see if giving protein in bolus doses reduces the loss of mid-upper arm circumference compared to continuous delivery, and whether this method better meets daily protein needs. This pilot study is conducted in a pediatric intensive care unit setting with careful monitoring and data collection. Participants will be randomly assigned to one of two groups: one receiving protein continuously mixed into enteral formula around the clock, and the other receiving supplemental protein as bolus doses every 4 hours alongside continuous formula feeding. Both groups will get the same amount of protein, aiming for 1 gram per kilogram per day of supplemental protein in addition to standard enteral nutrition. The intervention starts within the first few days of admission and lasts as long as the patient meets study criteria. Children in the study will have their nutrition intake tracked daily and undergo body composition assessments including weight, mid-upper arm circumference, and ultrasound measurements of thigh muscle at admission and on days 3, 5, 7, and 14 post-intervention start. Researchers will monitor changes over time and any significant clinical events to understand protein delivery effects and ensure data accuracy. The study includes follow-ups for up to two weeks with ongoing data analysis to evaluate outcomes.

CONDITIONS

Brief Title

Continuous vs Bolus Protein (Protein Regimen Outcomes) in Critically Ill Children (Kids In Distress)

Who Can Participate

Age: 1Year - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children admitted to pediatric intensive care unit aged over 1 year and younger than 11 years
  • Expected to stay in the pediatric intensive care unit for more than 72 hours
  • Receiving standard pediatric formula nutrition via nasogastric, orogastric, or gastrostomy tube ending in the stomach
Not Eligible

You will not qualify if you...

  • Neuromuscular conditions such as muscular dystrophy
  • Receiving high dose steroids at home, growth hormone, or insulin treatment
  • Enteral nutrition contraindicated or partially/fully replaced by parenteral nutrition
  • Nutrition formula delivered into the small bowel (duodenum or jejunum)
  • Need for highly specialized diet like large burns or metabolic diseases
  • Allergy to cow's milk protein preventing safe use of whey-based protein supplement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - Up to 14 days after admission

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit within 48 hours of admission if appropriate

Treatment

Duration - Typically starting within 72 to 96 hours after admission and continuing until discharge or change in nutrition regimen

Participants receive either continuous or bolus dietary protein supplementation alongside standard enteral nutrition to evaluate protein delivery methods.

Daily assessments during intervention for up to 14 days

Follow-up

Duration - 14 days from admission

Participants undergo nutrition status assessments including measurements of mid-upper arm circumference and quadricep ultrasound at admission, 7 days, and 14 days.

3 visits (at admission, Day 7, and Day 14)

Trial Site Locations

Total: 1 location

1

BC Childrens Hospital

Vancouver, British Columbia, Canada, V6H 3N1

Actively Recruiting

Loading map...

Research Team

K

Kaitlin A Berris, BSc

R

Rajavel Elango, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

PROTECT-ICU: Impact of an Educational Intervention on the Im...

Post Intensive Care Syndrome (PICS)

Actively Recruiting

2 locations

Establishment of a Multi-Center Big Data System for Severe I...

Critical Illness

Actively Recruiting

1 location

A Multi-Modal Combination Intervention to Promote Cognitive ...

Critical Illness

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Intermittent bolus feeding does not enhance protein synthesis, myonuclear accretion, or lean growth more than continuous feeding in a premature piglet model.

Marko Rudar, Jane K Naberhuis, Agus Suryawan...

https://pubmed.ncbi.nlm.nih.gov/34719946

Thigh ultrasound monitoring identifies muscle atrophy in mechanically ventilated pediatric patients.

Delia Valverde Montoro, Vanesa Rosa Camacho, Lourdes Artacho González...

https://pubmed.ncbi.nlm.nih.gov/37782351

A Practical Approach to Identifying Pediatric Disease-Associated Undernutrition: A Position Statement from the ESPGHAN Special Interest Group on Clinical Malnutrition.

Jessie M Hulst, Koen Huysentruyt, Konstantinos Gerasimidis...

https://pubmed.ncbi.nlm.nih.gov/35258497

Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: indicators recommended for the identification and documentation of pediatric malnutrition (undernutrition).

Patricia Becker, Liesje Nieman Carney, Mark R Corkins...

https://pubmed.ncbi.nlm.nih.gov/25422273