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Volume-based EN for Tube Feeding

N/A

Recruiting

Led By Tanis Fenton, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

"This trial aims to see if critically ill children in the hospital can be better fed using a new feeding method. The current method often results in interruptions, leading to inadequate nutrition. The researchers want to test

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include issues with feed tolerance such as gastrointestinal discomfort or complications related to improper nutrient delivery, but specific side effects will be monitored during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

10 semi structured qualitative interviews to to assess guardians/caregiver perception and experiences around deferred consent.

10 semi structured qualitative interviews to to assess patient experiences around deferred consent.

Assess participant enrollment and recruitment will be completed by documenting the number of children who successfully initiate the study protocol.

+5 more

Secondary outcome measures

60-day PICU mortality

60-day readmission to hospital

Admission Comorbidities

+19 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Volume-based ENExperimental Treatment1 Intervention

Volume-based EN algorithm arm.

Group II: Rate-based ENActive Control1 Intervention

Rate-based EN algorithm (standard of care).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Alberta Health servicesOTHER

158 Previous Clinical Trials

649,646 Total Patients Enrolled

American Society for Parenteral and Enteral NutritionOTHER

4 Previous Clinical Trials

180 Total Patients Enrolled

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,134 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals older than 35 years being actively sought for enrollment in this research project?

"This investigation is inclusive of individuals aged over 30 days and below 18 years old."

Answered by AI

Is the enrollment process currently open for this research study?

"Indeed, information available on clinicaltrials.gov indicates that this particular medical study is actively seeking participants. The trial was first made public on March 20th, 2024 and received its latest update on March 22nd, 2024. It aims to enroll a total of 20 patients from one designated site."

Answered by AI

Which individuals meet the criteria to participate in this medical research study?

"This trial is currently seeking 20 participants, aged between 1 month and 18 years old, who require tube feeding. Eligible individuals must also fulfill the subsequent conditions: Pediatric patients ranging from one month to eighteen years of age, those expected by either an intensivist or nurse practitioner to be hospitalized in the pediatric intensive care unit for a minimum of 48 hours, and those scheduled to commence enteral nutrition support."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"The main focus of this medical investigation, assessed within a period lasting up to 12 months, is the rationale behind participant attrition or withdrawal from the study. Secondary considerations encompass PICU mortality - denoting any demise during ACH PICU admission; Admission diagnosis indicating reasons for entering the PICU; and Admission Comorbidities detailing additional health conditions at time of entry into the PICU."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Does Volume-based Enteral Feeding Improve Nutrient Delivery in Hospitalized Critically Ill Children?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05286177.