Continuous vs Bolus Protein (Protein Regimen Outcomes) in Critically Ill Children (Kids In Distress)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-11
SponsorUniversity of British Columbia
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary protein
Dietary supplementBeneprotein 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.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Continuous proteinActive comparator 1 intervention
Group B: Bolus proteinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mid-upper arm circumference
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.
Time frame
admission, 7 and 14 daysSecondary outcomes
1
Ultrasound of the Rectus Femoris Quadricep
Ultrasound of the upper thigh (quadricep) muscle (rectus femoris) will be used (in centimeters) to compare with MUAC (in centimeters) and protein delivery (grams per day and percentage of minimum intake). This will be an exploratory measurement to detect the percentage change over time between ultrasound and MUAC. It will then be explored whether both protein groups (continuous vs bolus) have a similar change in percentage over time.
Time frame
admission, 7 and 14 daysSponsors and contacts
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Source ClinicalTrials.gov