Does Volume-based Enteral Feeding Improve Nutrient Delivery in Hospitalized Critically Ill Children?

NCT05286177 | Active Not Recruiting

• 1 other identifier: REB21-0773
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Background Some critically ill children have malnutrition which may worsen while they are in hospital and delay their return home. They can recover faster when they are given tube feedings to improve their nutrition. Unfortunately, in the hospital these feedings are often interrupted and so these children do not get all the nutrition they need. The usual procedure is to set hourly rates for the tube feedings and to accept that they get less when feedings are interrupted. The researchers would like to test if children are fed better if the bedside nurses were to check the volume provided through the day and then ensure the child gets closer to the prescribed volumes. Aim To determine the feasibility of performing a Randomized Control Trial assessing the use of a Volume-based feeding algorithm in critically ill children admitted to the Alberta Children's Hospital Pediatric Intensive Care Unit (PICU). Objectives

1. 1.Obtain information to inform sample size calculations for nutrition and clinical outcomes for a larger RCT: energy adequacy and protein adequacy, feed tolerance, infections, changes in anthropometric measurements at transitions of care, 28-day ventilator free days, length of stay, 60-day mortality, and 60-day hospital readmission?
2. 2.Assess adherence of medical staff to the study protocol
3. 3.Evaluate the timing of study enrollment and participant allocation
4. 4.Evaluate the proposed deferred consent strategy.

Conditions

Enteral Feeding

Outcome Measures

Primary Outcomes (8)

• Assess participant enrollment and recruitment will be completed by documenting the number of children who successfully initiate the study protocol.

  The investigators will evaluate the proposed inclusion/exclusion criteria, participant recruitment, and enrollment. On weekdays, during bedside rounds, the study coordinator will assess eligibility of admitted children against the inclusion/exclusion criteria. On Mondays the Study Coordinator will compare patients who were admitted over the weekend with the inclusion/exclusion criteria. After randomization, the number of children The investigators will evaluate the proposed inclusion/exclusion criteria, participant recruitment, and enrollment.

  Up to 12 months

• Number of deviations from assigned feeding algorithm.

  The Research Assistant will document if a deviation from the allocated feeding algorithm (volume-based or rate-based) occurred in the study database daily while participants are being fed via the research protocol.

  Up to 12 months

• Reason for participant attrition/withdraw from study.

  The research assistant will document the reason for participant removal from the study protocol in the secure REDcap database.

  Up to 12 months

• Day of participant attrition/withdraw from study.

  The research assistant will document the study day of participant removal from the study protocol in the secure REDcap database.

  Up to 12 months

• The length of time it takes between randomization of eligible participants to starting the assigned feeding algorithm to obtaining consent/assent.

  The time that randomization of an eligible participant occurs and the time that the participant starts the assigned feeding alogirhtm and the time that the Research Coordinator obtains consent/assent will be recorded.

  Up to 12 months

• Proportion of eligible subjects who provide consent/assent.

  The number of eligible subjects who provided consent/assent and the number who declined consent/assent will be recorded and used to assess the proportion of subjects who provide consent.

  Up to 12 months

• 10 semi structured qualitative interviews to to assess guardians/caregiver perception and experiences around deferred consent.

  Participants will be selected through purposive sampling of parents/guardians of patients enrolled in both arms of the EN trial. Zoom semi-structured interviews will be conducted. Interviews will be recorded for data analysis. A minimum sample size for interviews set a-priori will be 10, with additional interviews theme saturation in reached. Data collection will be stopped once no new themes emerge.

  Semi-structured interviews will take place after PICU discharge - up to 6 months

• 10 semi structured qualitative interviews to to assess patient experiences around deferred consent.

  Participants will be selected through purposive sampling of patients enrolled in both arms of the EN trial. Zoom semi-structured interviews will be conducted. Interviews will be recorded for data analysis. A minimum sample size for interviews set a-priori will be 10, with additional interviews theme saturation in reached. Data collection will be stopped once no new themes emerge.

  Semi-structured interviews will take place after PICU discharge - up to 6 months

Secondary Outcomes (22)

• Calories received - (daily total kcal)

  Up to 12 months

• Protein received - (daily total grams protein)

  Up to 12 months

• Enteral feeding route use - gastric or post-pyloric

  Up to 12 months

• Participant height in centimeters

  Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.

• Participant weight in kilograms

  Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.

Study Arms (2)

Volume-based EN

EXPERIMENTAL

Volume-based EN algorithm arm.

Procedure: Volume-based EN

Rate-based EN

ACTIVE COMPARATOR

Rate-based EN algorithm (standard of care).

Procedure: Rate-based EN

Interventions

Volume-based EN PROCEDURE

Bedside nurses will receive a total daily feed volume prescription to be administered to the participant over a 24-hour period. The bedside nurse will calculate the initial hourly rate by dividing the total daily feed goal by 24 hours at approximately 0700 hours. In this intervention group, they will be instructed to titrate the rate of feeds to accommodate for any feeding interruptions as follows: When feeds are held for \> 1 hour, the remaining daily feed volume will be divided by the remaining number of hours. A maximum infusion rate will be set at 2 times the patient's baseline 24-hour feed rate to ensure that a large bolus volume of feed is not administered over a too short period of time.

Volume-based EN

Rate-based EN PROCEDURE

Bedside nurses will receive an hourly feed rate prescription to administer the tube feedings over a 24-hour period. If feeds are held, they will be restarted at the same consistent hourly rate that was previously ordered. Nurses will not adjust feed rates to compensate for feed interruptions

Rate-based EN

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children 1-month post-natal age to 18 years of age
• Children anticipated by the intensivist or nurse practitioner to be admitted to the PICU for ≥ 48 hours
• Children who will be initiated on EN support

You may not qualify if:

• Children will not be eligible for this study if they are palliative
• Children who have contraindications to EN (i.e., a non-functional GI tract)
• Children who are on parenteral nutrition
• Children who are being fed by a bolus feed regime
• Children who cannot progress past trophic feed volumes within 24 hours of EN initiation
• Children anticipated to be admitted to PICU for \<48 hours

Sponsors & Collaborators

• University of Calgary: lead
• American Society for Parenteral and Enteral Nutrition: collaborator
• Alberta Health services: collaborator

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, 73b6a8, Canada

Location

Study Officials

• Tanis Fenton, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A double-blinded strategy is not feasible for this study because the medical team cannot remain adequately blinded to study arms after randomization. Bedside nurses delivering EN support need to know which feeding algorithm to follow. The medical team (including PICU physicians, nurse practitioners, and dietitians) have access to patients' medical records which include current hourly infusion rates of enteral feeds so they will be able to deduce the patients' allocations. The team uses current hourly infusion rates to assess fluid balance and to make clinical decisions. To minimize bias, the research assistant tasked with data collection will remain blinded to study allocation throughout data collection and will enter the data into the REDCap Database in a blinded fashion. After data collection and prior to data analysis, all identifying information will be saved in a separate file to ensure the Study Coordinator will be re-blinded to participant allocation during data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will conduct a single-center parallel partially blinded 1:1 randomized feasibility trial of 20 children admitted to the Alberta Children's Hospital (ACH) PICU.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: March 18, 2022
• Study Start: March 20, 2024
• Primary Completion: November 30, 2024
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)