Harry M. Vars Award Candidates Abstracts
Background: Enteral nutrition (EN) has been associated with better clinical outcomes in critically ill children.However, frequent feed interruptions are common, resulting in underfeeding.Traditionally, tube feeds are provided using hourly rate-based feeding goals.Volume-based feeding allows nurses to adjust feed rates to compensate for interruptions.This study examined the feasibility of conducting a randomized controlled trial (RCT) to evaluate volume-based EN (VBEN) in the pediatric intensive care unit (PICU) by assessing participant recruitment, enrollment and consent rates, protocol adherence and secondary clinical outcomes in order to inform the design of a future study.Methods: We conducted a parallel, partially blinded 1:1 randomized feasibility trial of children admitted to the Alberta Children's Hospital PICU from March to November 2024.Eligible children were 1 month to 18 years old, expected to remain in the PICU 48 hours, and require EN.Randomization was block-stratified by age and ventilator support.A deferred consent strategy was used to facilitate timely enrollment, randomization, and protocol initiation.After 24 hours of feed initiation and titration, participants received either the unit standard or intervention: Comparator (RBEN, unit standard): Nurses followed a fixed hourly feed rate with no adjustments for missed volumes.Intervention (VBEN): Nurses were provided a 24-hour target feed volume and instructed to adjust rates following interruptions, within a predefined maximum rate to avoid rapid infusions.Daily data was collected from enrollment to PICU discharge or 7 days of study protocol, whichever came first.Participants were analyzed according to the intention-to-treat principle.Results: A total of 436 children were screened for eligibility.Of these, 120 (28%) met the initial inclusion criteria.After applying exclusion criteria, 61 children (51%) remained eligible and 60 (98%) were successfully enrolled and randomized.One child was enrolled but never started on EN.Among 178 study days, five protocol violations occurred (2.8%); two due to incorrect study orders entered in the electronic medical system and three due to feed rates administered outside the VBEN protocol parameters.Notably, feed rates were never run above the maximum infusion rate.One child with an undiagnosed metabolic disorder was removed from the study by the medical team to allow for closer titration of parenteral and enteral nutrition.Consent was declined by two participants (3.2%) prior to protocol initiation and by seven participants (11.5%) after study protocol had started, resulting in an overall consent rate of 85.0%.Baseline characteristics were similar between groups, except for more females in the VBEN group (p = 0.01) (Table 1).VBEN showed non-significantly higher energy and protein adequacy (Figure 2), a lower cumulative energy deficit (273 vs. 861 kcal, p = 0.04) (Table 1), and no increase in feed intolerance (p = 0.46) (Table 1) compared with RBEN.Secondary outcomes were underpowered to detect differences, and findings should be considered exploratory and hypothesis-generating. Conclusion:This study demonstrates the feasibility of conducting a RCT of VBEN in a PICU.High enrollment (98%) and consent (85%) rates, potentially facilitated by a deferred consent strategy, support the acceptability of the trial design.Protocol adherence
Publication Details
- Journal
- Journal of Parenteral and Enteral Nutrition
- Published
- 2026-01-20
- DOI
- https://doi.org/10.1002/jpen.70046
- Primary Topic
- Diverse Scientific and Economic Studies
- Type
- article
- Field-Weighted Citation Impact
- 0.00