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Dietary Supplement
Intermittent vs Continuous Tube Feeding for Malnutrition
N/A
Waitlist Available
Led By Melissa P Knauert, MD, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intubation day 1 to intubation day 10
Awards & highlights
Study Summary
This trial is investigating whether it is more effective to give a patient goal nutrition intermittently or continuously.
Who is the study for?
This trial is for adults over 18 who are on mechanical ventilation via an endotracheal tube, intubated within 72 hours of hospital admission, and in the Medical ICU for the first time this stay. Excluded are those with GI obstructions, chronic enteral nutrition before admission, significant esophageal issues, at risk of refeeding syndrome, pregnant women or those excluded by their doctor.Check my eligibility
What is being tested?
The study compares two ways to feed patients through a tube: intermittent feeding (at certain times) versus continuous feeding (all the time). It looks at how well each method delivers recommended daily calories to patients in the Medical Intensive Care Unit.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort or intolerance due to different feeding schedules. The risks associated with each type of enteral nutrition will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intubation day 1 until 14 days later
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intubation day 1 until 14 days later
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended calories
Secondary outcome measures
Percentage of patients experiencing intolerance of feeding
Percentage of patients with aspiration
delirium
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Intermittent feedExperimental Treatment1 Intervention
Patients will be assigned to receive intermittent enteral feeding protocol. They will receive four equal volume feeds at 8:00, 12:00, 16:00, and 20:00 hours.
Group II: Continuous feedsExperimental Treatment1 Intervention
Patients will be assigned to receive continuous enteral feeding protocol. Typical goal rates are in the range of 60 to 80 mL per hour for 24 hours per day.
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,862 Previous Clinical Trials
2,742,448 Total Patients Enrolled
1 Trials studying Malnutrition
5,773 Patients Enrolled for Malnutrition
Melissa P Knauert, MD, PhDPrincipal InvestigatorYale University
1 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on tube feeding for at least 6 hours and can start intermittent feeding soon.I do not speak English.I have had a cardiac arrest during my current hospital stay.I am currently receiving treatment that affects my muscle function.I have had severe sugar emergencies or use a device to monitor/control my sugar.I have had a blockage in my small intestine recently or now.I have a history of delayed stomach emptying.My feeding tube does not go beyond my stomach or cannot have one placed.I am 18 years old or older.I am scheduled to be taken off a ventilator within 24 hours.I have had surgery that changed the upper part of my stomach or intestines.I was not given a nutrition plan within 3 days of being put on a breathing machine.I have a feeding tube or a tracheostomy.I cannot have my head raised to 30 degrees while intubated and fed.I have a history of severe swallowing issues, but GERD is okay.I have a blockage in my digestive tract caused by a tumor.
Research Study Groups:
This trial has the following groups:- Group 1: Intermittent feed
- Group 2: Continuous feeds
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of test subjects participating in this clinical experiment?
"Yes, the clinicaltrials.gov records demonstrate that this trial is currently enlisting participants. It was initially posted on July 7th 2020 and modified as recently as October 20th 2022. 150 volunteers are being sought in total from a single site."
Answered by AI
Are there any vacancies to participate in this experiment?
"Affirmative. Clinicaltrials.gov has indicated that the clinical trial is still enlisting candidates, with initial posting on July 7th 2020 and last edit made on October 20th 2022. 150 participants need to be enrolled across a single site for this study's success."
Answered by AI
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