Volume-Based Tube Feeding for Critically Ill Children

Overseen By Tanis Fenton, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Palliative, Non-functional GI tract, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of feeding critically ill children in the hospital to determine if it improves their nutrition. The standard method, rate-based enteral nutrition (EN), feeds at a set rate. This trial will evaluate whether monitoring the total amount fed throughout the day, known as volume-based enteral nutrition (EN), is more effective. Children who have stayed in the hospital's Pediatric Intensive Care Unit for at least 48 hours and require tube feeding may qualify for this study. The goal is to discover if this new feeding method can enhance the children's recovery and hospital stay. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It focuses on tube feeding methods for critically ill children.

What prior data suggests that this volume-based feeding algorithm is safe for critically ill children?

Research has shown that volume-based feeding can safely improve nutrition in very sick patients. One study found that this method significantly increased the calories and protein patients received without adding extra risk. This indicates that the volume-based approach is well-tolerated. No additional negative effects have been reported with this method. Based on this evidence, it appears to be a safe option for improving nutrition in hospitalized children who need tube feeding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the volume-based enteral nutrition (EN) approach for critically ill children because it offers a more tailored way to meet each child's nutritional needs. Unlike the standard rate-based EN, which delivers nutrition at a constant rate, the volume-based method adjusts the feeding volume based on the child's tolerance and nutritional requirements. This could potentially enhance nutritional delivery, improve recovery times, and reduce the risk of complications associated with underfeeding or overfeeding. By customizing the nutritional intake, this method aims to provide more effective and responsive care for critically ill children.

What evidence suggests that this trial's feeding algorithms could be effective for critically ill children?

Research has shown that a volume-based feeding plan, one of the treatment arms in this trial, can significantly improve the delivery of necessary calories and protein to critically ill patients without increasing risks. One study found that children fed using this method experienced fewer interruptions in their feeding. Another study reported that from 2021 to 2024, the percentage of critically ill patients reaching their feeding goals rose from 62% to 86% with volume-based feeding. Additionally, this method has been shown to reduce the risk of death by 15%. Overall, these findings suggest that volume-based feeding can enhance nutrition delivery and potentially lead to better health outcomes in critically ill children. Meanwhile, the trial will also evaluate the rate-based feeding plan, which serves as the standard of care comparator. ^{1 2 3 6 7}

Who Is on the Research Team?

Tanis Fenton, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for critically ill children aged 1 month to 18 years who are expected to stay in the Pediatric Intensive Care Unit (PICU) for at least 48 hours and need tube feeding. It excludes those not meeting these criteria.

Inclusion Criteria

Children anticipated by the intensivist or nurse practitioner to be admitted to the PICU for ≥ 48 hours

My child is starting on enteral nutrition support.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either volume-based or rate-based enteral nutrition algorithms in the PICU

Up to 12 months

Daily monitoring in PICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of nutrition adequacy and clinical outcomes

Up to 60 days

Deferred Consent Evaluation

Evaluation of the deferred consent strategy through qualitative interviews with caregivers and patients

Up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Rate-based EN
• Volume-based EN

Trial Overview The study tests if volume-based enteral feeding, where nurses ensure kids get their prescribed nutrition despite interruptions, leads to better outcomes than standard rate-based feedings in a PICU setting.

How Is the Trial Designed?

Group I: Volume-based EN Experimental Treatment 1 Intervention

Volume-based EN algorithm arm.

Group II: Rate-based EN Active Control 1 Intervention

Rate-based EN algorithm (standard of care).

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

American Society for Parenteral and Enteral Nutrition

Collaborator

Trials

5

Recruited

200+

Published Research Related to This Trial

In a study of 180 critically ill children, those fed with a peptide-based formula experienced significantly fewer feeding interruptions and abdominal distention, and they reached full enteral feeding much faster (2.60 days vs. 5.36 days for the standard formula).

While the peptide-based formula led to improved weight gain and a shorter duration of sepsis, there was no significant difference in mortality rates between the two groups, suggesting that while it may improve feeding tolerance, further evaluation is needed for its overall impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peptide-based formula versus standard-based polymeric formula for critically ill children: is it superior for patients' tolerance? Ibrahim, H., Mansour, M., El Gendy, YG.[2023]

The implementation of an enteral nutrition (EN) protocol in a pediatric intensive care unit (PICU) significantly improved the percentage of patients meeting their nutritional goals within the first 48 hours from 18% to 88%.

Following the introduction of clinical decision support tools and a standardized order set, the median time to start EN and reach goal nutrition decreased, and the length of stay in the PICU was reduced from 202 hours to 156 hours, indicating better nutritional management and improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Decision Support Tools and a Standardized Order Set Enhances Early Enteral Nutrition in Critically Ill Children. Ziemba, KJ., Kumar, R., Nuss, K., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05286177

Does Volume-based Enteral Feeding Improve Nutrient ... Aim To determine the feasibility of performing a Randomized Control Trial assessing the use of a Volume-based feeding algorithm in critically ill children ...

2. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-023-04439-0

an updated meta-analysis and systematic review | Critical Care Our study revealed that the VBF protocol significantly improved calorie and protein delivery in critically ill patients with no additional risk.

3. withpower.com withpower.com/trial/phase-enteral-feeding-5-2022-5bc87

Volume-Based Tube Feeding for Critically Ill Children In a study of 180 critically ill children, those fed with a peptide-based formula experienced significantly fewer feeding interruptions and abdominal ...

4. jandonline.org jandonline.org/article/S2212-2672(25)00269-2/fulltext

Improving the Volume-based Feeding Process in Intensive ... From 2021 to 2024, the average annual percentage of critically ill patients meeting within 20% of their total feeding goal volume increased from 62% to 86%.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5009025/

Effectiveness of enteral feeding protocol on clinical outcomes ... The enteral feeding protocol is able to reduce the mortality by 15%. The study design will provide 80% power and 2.5% (1-sided) type I error.

6. cumming.ucalgary.ca cumming.ucalgary.ca/sites/default/files/teams/29/Gilbert%2C%20Nicole%20PhD%20Proposal%20Jan%207%20NG.pdf

Evaluating the evidence for using a volume-based enteral ... This proposed randomized feasibility trial will provide evidence on the feasibility of conducting a larger RCT evaluating the use of volume- ...

7. e-acnm.org e-acnm.org/journal/view.php?number=279

Comparison of a volume-based feeding protocol with ... We aimed to identify the effect of achieving early enteral nutrition goals and improving outcomes through a volume-based feeding (VBF) protocol for trauma ...