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

Enteral Feeding

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    1 to 18

Participation Criteria

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

Study Location

Alberta Children's Hospital
Alberta Children's Hospital
Calgary, Alberta
Canada

Contact Study Team

Backup Contact

Taheera Tharani

[email protected]
403 955 2508
Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: NCT05286177