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

NCT06721923 | Recruiting

• 1 other identifier: H23-00276
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness; Pediatric Intensive Care; Enteral Nutrition Therapy; Dietary Protein

Keywords

enteral nutrition; pediatric critical care; bolus protein delivery; continuous protein delivery; ultrasound; mid-upper arm circumference

Outcome Measures

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.

  admission, 7 and 14 days

Secondary Outcomes (1)

• Ultrasound of the Rectus Femoris Quadricep

  admission, 7 and 14 days

Study Arms (2)

Continuous protein

ACTIVE COMPARATOR

Continuous protein arm will have dietary protein supplement mixed into the enteral formula product to be provided around the clock without break.

Dietary Supplement: Dietary protein

Bolus protein

EXPERIMENTAL

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.

Dietary Supplement: Dietary protein

Interventions

Dietary protein DIETARY_SUPPLEMENT

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.

Bolus protein; Continuous protein

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Childrens Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

Related Publications (8)

• El-Kadi SW, Boutry C, Suryawan A, Gazzaneo MC, Orellana RA, Srivastava N, Nguyen HV, Kimball SR, Fiorotto ML, Davis TA. Intermittent bolus feeding promotes greater lean growth than continuous feeding in a neonatal piglet model. Am J Clin Nutr. 2018 Oct 1;108(4):830-841. doi: 10.1093/ajcn/nqy133.

  PMID: 30239549 BACKGROUND

• Davis TA, Fiorotto ML, Suryawan A. Bolus vs. continuous feeding to optimize anabolism in neonates. Curr Opin Clin Nutr Metab Care. 2015 Jan;18(1):102-8. doi: 10.1097/MCO.0000000000000128.

  PMID: 25474017 BACKGROUND

• Rudar M, Naberhuis JK, Suryawan A, Nguyen HV, Stoll B, Style CC, Verla MA, Olutoye OO, Burrin DG, Fiorotto ML, Davis TA. Intermittent bolus feeding does not enhance protein synthesis, myonuclear accretion, or lean growth more than continuous feeding in a premature piglet model. Am J Physiol Endocrinol Metab. 2021 Dec 1;321(6):E737-E752. doi: 10.1152/ajpendo.00236.2021. Epub 2021 Nov 1.

  PMID: 34719946 BACKGROUND

• Ong C, Lee JH, Senna S, Chia AZH, Wong JJM, Fortier MV, Leow MKS, Puthucheary ZA. Body Composition and Acquired Functional Impairment in Survivors of Pediatric Critical Illness. Crit Care Med. 2019 Jun;47(6):e445-e453. doi: 10.1097/CCM.0000000000003720.

  PMID: 30958426 BACKGROUND

• Ong C, Lee JH, Wong JJM, Leow MKS, Puthucheary ZA. Skeletal Muscle Changes, Function, and Health-Related Quality of Life in Survivors of Pediatric Critical Illness. Crit Care Med. 2021 Sep 1;49(9):1547-1557. doi: 10.1097/CCM.0000000000004970.

  PMID: 33861558 BACKGROUND

• Valverde Montoro D, Rosa Camacho V, Artacho Gonzalez L, Camacho Alonso JM. Thigh ultrasound monitoring identifies muscle atrophy in mechanically ventilated pediatric patients. Eur J Pediatr. 2023 Dec;182(12):5543-5551. doi: 10.1007/s00431-023-05233-4. Epub 2023 Oct 2.

  PMID: 37782351 BACKGROUND

• Hulst JM, Huysentruyt K, Gerasimidis K, Shamir R, Koletzko B, Chourdakis M, Fewtrell M, Joosten KF; Special Interest Group Clinical Malnutrition of ESPGHAN. A Practical Approach to Identifying Pediatric Disease-Associated Undernutrition: A Position Statement from the ESPGHAN Special Interest Group on Clinical Malnutrition. J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):693-705. doi: 10.1097/MPG.0000000000003437. Epub 2022 Mar 3.

  PMID: 35258497 BACKGROUND

• Becker P, Carney LN, Corkins MR, Monczka J, Smith E, Smith SE, Spear BA, White JV; Academy of Nutrition and Dietetics; American Society for Parenteral and Enteral Nutrition. 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). Nutr Clin Pract. 2015 Feb;30(1):147-61. doi: 10.1177/0884533614557642. Epub 2014 Nov 24.

  PMID: 25422273 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Dietary Proteins

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Rajavel Elango, PhD

  University of British Columbia, Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlin A Berris, BSc

CONTACT

604-875-2000; kaitlin.berris@bcchr.ca

Rajavel Elango, PhD

CONTACT

604-875-2000; relango@bcchr.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: December 6, 2024
• Study Start: February 13, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 12, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)