Critical IllnessPediatric Intensive CareEnteral Nutrition TherapyDietary Protein
Investigational drug(s) / intervention(s)
Dietary protein
Dietary protein: Beneprotein powder, a whey-based supplement, will be used in both arms. Intervention dose will be 1g/kg of dietary protein (or 1.2g/kg of the powder), provided to both arms with different modes of delivery.
Study summary
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.
Eligibility
Sex
ALL
Min age
1 Year
Max age
11 Years
Healthy volunteers
No
Inclusion Criteria:
* Children admitted to PICU over 1 year of age and younger than 11 years of life
* Expected to remain in the pediatric intensive care unit for longer than 72 hours
* Receiving standard pediatric formula via NGT/OGT/GT
Exclusion Criteria:
* Neuromuscular condition such as muscular dystrophy
* 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
* Formula delivered into the small bowel (duodenum/jejunum, NJT/GJ)
* Those who require a highly specialized diet (E.g., large burns or metabolic diseases)
* Patients with a cow's milk protein allergy cannot safely receive a whey-based protein supplement
Primary outcome measure(s)
Mid-upper arm circumference — admission, 7 and 14 days Mid-upper arm circumference (MUAC) will be the primary outcome measure with a standard deviation change in z-score of 0.5 being considered significant. The measure (in centimeters) will be assessed against the WHO validated growth standard (for sex and age) and reported as z-score to standardized the measures against the population as a whole.
Trial sites (1)
Facility
City
Region
Status
BC Childrens Hospital
Vancouver
British Columbia
Recruiting
More University of British Columbia trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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