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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of volume-based tube feeding for critically ill children?

There is some evidence that using enteral nutrition protocols, which include volume-based feeding, can reduce gastrointestinal and infection complications and help start and reach feeding goals faster in critically ill children. ^{1 2 3 4 5}

Is volume-based tube feeding safe for critically ill children?

There is low-level evidence suggesting that using enteral nutrition protocols, which include volume-based feeding, may reduce gastrointestinal and infection-related complications in critically ill children. However, more research is needed to confirm these findings and ensure safety. ^{1 5 6 7 8}

How is volume-based enteral nutrition different from other treatments for critically ill children?

Volume-based enteral nutrition (EN) is unique because it adjusts the feeding rate to ensure a set amount of nutrition is delivered each day, even if there are interruptions. This differs from traditional methods that use a fixed hourly rate, which can lead to underfeeding if the feeding is paused for any reason. ^{5 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Tanis Fenton, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Protocol-driven enteral nutrition in critically ill children: a systematic review. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical Decision Support Tools and a Standardized Order Set Enhances Early Enteral Nutrition in Critically Ill Children. [2020]

3. Poland pubmed.ncbi.nlm.nih.gov

Peptide-based formula versus standard-based polymeric formula for critically ill children: is it superior for patients' tolerance? [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Use of a feeding protocol to improve nutritional support through early, aggressive, enteral nutrition in the pediatric intensive care unit. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Volume-Based Feeding in the Critically Ill Patient. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Clinically relevant differences in accuracy of enteral nutrition feeding pump systems. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Volume-Based Protocol Improves Delivery of Enteral Nutrition in Critically Ill Trauma Patients. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Volume-Based Feeding Enhances Enteral Delivery by Maximizing the Optimal Rate of Enteral Feeding (FEED MORE). [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Enteral Nutrition Practices in Critically Ill Children Requiring Noninvasive Positive Pressure Ventilation. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Volume-based feeding improves nutritional adequacy in surgical patients. [2019]