Volume-based EN: 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.
Rate-based EN: 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
Study 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. 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. Assess adherence of medical staff to the study protocol
3. Evaluate the timing of study enrollment and participant allocation
4. Evaluate the proposed deferred consent strategy.
Methods The researchers will conduct a randomized control feasibility trial of critically ill children admitted to the Alberta Children's Hospital (ACH) Pediatric Intensive Care unit who require tube feedings. Children will be randomly assigned to the intervention arm (Volume-based algorithm) or the comparison arm (rate-based algorithm).
Significance The proposed study will provide evidence of whether a novel approach to feeding critically ill children is feasible during PICU admission. This trial will inform a larger Randomized Control Trial on this topic that will assess if using a Volume-based feeding algorithm will improve outcomes of clinical importance including energy adequacy, protein adequacy, feed tolerance, infections, changes in anthropometric measurements at transitions of care, 28-day ventilator free days, length of stay in PICU and hospital, 60-day mortality, and 60-day hospital readmission.
Eligibility
Sex
ALL
Min age
1 Month
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Assess participant enrollment and recruitment will be completed by documenting the number of children who successfully initiate the study protocol. — Up to 12 months 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.
Number of deviations from assigned feeding algorithm. — Up to 12 months 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.
Reason for participant attrition/withdraw from study. — Up to 12 months The research assistant will document the reason for participant removal from the study protocol in the secure REDcap database.
Day of participant attrition/withdraw from study. — Up to 12 months The research assistant will document the study day of participant removal from the study protocol in the secure REDcap database.
The length of time it takes between randomization of eligible participants to starting the assigned feeding algorithm to obtaining consent/assent. — Up to 12 months 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.
Proportion of eligible subjects who provide consent/assent. — Up to 12 months 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.
10 semi structured qualitative interviews to to assess guardians/caregiver perception and experiences around deferred consent. — Semi-structured interviews will take place after PICU discharge - up to 6 months 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.
10 semi structured qualitative interviews to to assess patient experiences around deferred consent. — Semi-structured interviews will take place after PICU discharge - up to 6 months 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.
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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