Enteral FeedingNCT04437264
Intermittent Versus Continuous Enteral Nutrition in Mechanically Ventilated Patients in the Medical Intensive Care Unit
A study testing Intermittent feed participant and Continuous feeds participant in people with Enteral Feeding and Nutrition Disorders, run by Yale University at 1 site in United States.
Trial summary
Evaluate effective delivery of goal nutrition with intermittent as compared with continuous enteral nutrition schedules, as defined by percentage of recommended calories that patient receives per day of interest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Feeding, Nutrition Disorders
- What is being tested?
- Intermittent feed participant and Continuous feeds participant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 7 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MICU Yale New Haven Hospital
- Age >= 18 years old.
- Patients mechanically ventilated via endotracheal tube
- Patients intubated within 72 hours of hospital admission
- First intubation of current hospitalization
- First MICU admission of current hospitalization
Who cannot join
- Patient has opted out of research participation via institutional patient portal.
- At significant risk for gastrointestinal intolerance of intermittent bolus feeds:
- Prior upper gastrointestinal surgery that alters proximal GI anatomy (including but not limited to gastric bypass surgery, gastric banding, complete or partial gastrectomy, Whipple procedure; of note, appendectomy and cholecystectomy are not exclusion criteria.
- Structural gastrointestinal obstruction (such as tumor).
- Chronic enteral nutrition (prior to current admission).
- History of significant esophageal dysmotility (history of GERD is acceptable) or clinically significant GE junction incompetence
Show all 24Show fewer
- Unable to have head of bed elevated at least 30 degrees while intubated and being fed (this is standard protocol).
- Enteral access terminates post-pyloric (ie nasojejunal or jejunostomy tubes are to be excluded) or unable to place gastric tube for access. (The clinical team will determine type of tube placement. As this is particularly selected by intensivists for patients at higher aspiration risk, this tube enteral access exclusion de facto excludes patients at high aspiration risk.)
- History of small bowel obstruction or ileus on current admission or within last 1 month.
- History of gastroparesis.
- Percutaneous gastrostomy tube or tracheostomy.
- History of ongoing aspiration as determined by a speech medicine specialist or other medical professional or a patent who required adjustment of diet (e.g., thickening of liquids) prior to hospitalization.
- History of significant esophageal dysmotility (history of GERD is acceptable) or clinically significant GE junction incompetence
- Other Exclusion Criteria:
- At risk of refeeding syndrome.
- Pregnant patients.
- Patients receiving neuromuscular blockade.
- Patients with glycemic emergency (HHNK, DKA, severe hypoglycemia resulting in MICU admission) or patients controlling their sugar / insulin dosing via continuous glucose monitoring
- Post cardiac arrest (on current admission).
- Received >= 6 hours of enteral nutrition (regardless of volume) at the time of screening and team is able to consent / enroll / initiate intermittent feed within an additional 2 hours.
- Plan for extubation within 24 hours.
- Not English-speaking.
- Patients otherwise excluded by the treating physician.
- Retrospective exclusion: patients who initially met eligibility criteria, but no nutrition consult (i.e., decision to initiate feeds by clinical providers) placed within 72 hours of intubation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital, York Street Campus
New Haven, Connecticut, 06520
About this study
Evaluate effective delivery of goal nutrition with intermittent as compared with continuous enteral nutrition schedules, as defined by percentage of recommended calories that patient receives per day of interest.
Read the detailed description
Eligible patients will be approached and if the patient (or surrogate decision maker) is interested, then consent will be obtained for participation in the study. The patient will then be randomly assigned to receive usual care (continuous feeds) or intervention (intermittent feeds, see details below). Randomization will occur via simple block randomization within the REDCap software. Group assignment will not be revealed to the clinical team until the decision to feed the patient has occurred and the actual feeding order is entered. When the clinical team decides to initiate enteral nutrition, they will place a nutrition consult order for tube feed recommendations. Nutrition consult will place recommendations for both continuous feeding and for intermittent schedule, including enteral nutrition formula and dosing. Prior to feeds being started, the patient's randomization status will be revealed to the clinical team. The covering provider will then place the order for enteral nutrition according to the nutritionist's recommendations for the correct feeding schedule.
For patients randomized to continuous feeds, their enteral nutrition will be ordered and delivered as per usual care and standard MICU procedure. Nutritionist will provide recommendations for initiation rate, up titration schedule, and maintenance dosing to be delivered continuously over 24 hours. Under usual care of ICU patients, our clinical nutritionists provide a specified formula, a specified calorie goal, and a suggested titration rate. This is typically 20 mL per hour to start with an increase in rate of 20 mL per hour every 6 to 8 hours until the goal rate is achieved. Typical goal rates are in the range of 60 to 80 mL per hour for 24 hours per day.
For patients randomized to the intervention group (intermittent feeds), they will receive their enteral nutrition according to a research protocol schedule. This will involve the total recommended feed volume divided into four equal volume "meals." These will be delivered at a rate of 400 cc/hr at 8:00, 12:00, 16:00, and 20:00. The up-titration schedule will be as follows: first meal will be 100 mL, and the volume of each meal thereafter will be increased by 100mL until patient is at goal volume (typically between 300 and 450 mL). There are no formula or diets that are inappropriate to be administered on an intermittent feed schedule. The intervention will not change formula selection or total calorie goals. It will only change the schedule of feeding. For all patients, regardless of feeding schedule, the Kangaroo E-Pump will be used to deliver enteral nutrition, and the above rate and volume parameters can be programmed in.
There will be no change in delivery of enteral free water or medications. This schedule will be determined by nursing and clinical care team, as is the current standard of care. To assure correct ordering of intermittent feeds and the insulin prior to each meal, an EPIC orderset with prepopulated instructions will be developed.
If there are no signs of or clinical concerns for intolerance, patients will continue to receive enteral nutrition according to assigned schedule until they are extubated or until enteral nutrition is discontinued.
- Conditions
- Enteral Feeding, Nutrition Disorders
- Being tested
- Intermittent feed participant, Continuous feeds participant
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent feed participantDietary supplement
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.
Continuous feeds participantDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent feed | Experimental | 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. Receives: Dietary Supplement: Intermittent feed participant |
| Continuous feeds | Experimental | 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. Receives: Dietary Supplement: Continuous feeds participant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended calories
percentage of recommended calories that patient receives per day of interest during study period
Measured: Intubation day 1 to intubation day 10
Secondary outcomes (8)
Percentage of patients with aspiration
percentage of patients experiencing aspiration
Measured: Intubation day 1 to intubation day 10
Percentage of patients experiencing intolerance of feeding
percentage of patients experiencing intolerance of feeding including nausea, vomiting, diarrhea, ileus
Measured: Intubation day 1 to intubation day 10
feasibility: proportion complete protocol
percentage of patients assigned to intervention (ie intermittent feeding protocol) that remain on study protocol for study period of interest.
Measured: Intubation day 1 to intubation day 10
delirium
number of delirium and coma free days out of 14 following intubation
Measured: intubation day 1 until 14 days later
urine 6-sulfatoxymelatonin acrophase
Urine 6-sulfatoxymelatonin acrophase defined as the time of fitted peak 6-sulfatoxymelatonin from fitting a cosine curve to hourly urine aMT6s levels will be determined daily
Measured: day 1 to 3 following initiation of feeds
maximum glucose
highest glucose per day of interest
Measured: Intubation day 1 to intubation day 10
minimum glucose
lowest glucose per day of interest
Measured: Intubation day 1 to intubation day 10
insulin usage
number of insulin units used per day (composite of short and long acting formulations)
Measured: Intubation day 1 to intubation day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start7 Jul 2020
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral FeedingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa P Knauert, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437264
- Sponsor's protocol ID
- 2000027328
- Status last verified
- Feb 2025
- First submitted
- 19 May 2020
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data can be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Versus Continuous Enteral Nutrition in Mechanically Ventilated Patients in the Medical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04437264
- Acronym / sponsor ID
- 2000027328
- Conditions
- Enteral Feeding, Nutrition Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate effective delivery of goal nutrition with intermittent as compared with continuous enteral nutrition schedules, as defined by percentage of recommended calories that patient receives per day of interest.
Detailed description
Eligible patients will be approached and if the patient (or surrogate decision maker) is interested, then consent will be obtained for participation in the study. The patient will then be randomly assigned to receive usual care (continuous feeds) or intervention (intermittent feeds, see details below). Randomization will occur via simple block randomization within the REDCap software. Group assignment will not be revealed to the clinical team until the decision to feed the patient has occurred and the actual feeding order is entered. When the clinical team decides to initiate enteral nutrition, they will place a nutrition consult order for tube feed recommendations. Nutrition consult will place recommendations for both continuous feeding and for intermittent schedule, including enteral nutrition formula and dosing. Prior to feeds being started, the patient's randomization status will be revealed to the clinical team. The covering provider will then place the order for enteral nutrition according to the nutritionist's recommendations for the correct feeding schedule.
For patients randomized to continuous feeds, their enteral nutrition will be ordered and delivered as per usual care and standard MICU procedure. Nutritionist will provide recommendations for initiation rate, up titration schedule, and maintenance dosing to be delivered continuously over 24 hours. Under usual care of ICU patients, our clinical nutritionists provide a specified formula, a specified calorie goal, and a suggested titration rate. This is typically 20 mL per hour to start with an increase in rate of 20 mL per hour every 6 to 8 hours until the goal rate is achieved. Typical goal rates are in the range of 60 to 80 mL per hour for 24 hours per day.
For patients randomized to the intervention group (intermittent feeds), they will receive their enteral nutrition according to a research protocol schedule. This will involve the total recommended feed volume divided into four equal volume "meals." These will be delivered at a rate of 400 cc/hr at 8:00, 12:00, 16:00, and 20:00. The up-titration schedule will be as follows: first meal will be 100 mL, and the volume of each meal thereafter will be increased by 100mL until patient is at goal volume (typically between 300 and 450 mL). There are no formula or diets that are inappropriate to be administered on an intermittent feed schedule. The intervention will not change formula selection or total calorie goals. It will only change the schedule of feeding. For all patients, regardless of feeding schedule, the Kangaroo E-Pump will be used to deliver enteral nutrition, and the above rate and volume parameters can be programmed in.
There will be no change in delivery of enteral free water or medications. This schedule will be determined by nursing and clinical care team, as is the current standard of care. To assure correct ordering of intermittent feeds and the insulin prior to each meal, an EPIC orderset with prepopulated instructions will be developed.
If there are no signs of or clinical concerns for intolerance, patients will continue to receive enteral nutrition according to assigned schedule until they are extubated or until enteral nutrition is discontinued.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent feed | Experimental | Dietary Supplement: Intermittent feed participantPatients 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. |
| Continuous feeds | Experimental | Dietary Supplement: Continuous feeds participantPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- MICU Yale New Haven Hospital
- Age >= 18 years old.
- Patients mechanically ventilated via endotracheal tube
- Patients intubated within 72 hours of hospital admission
- First intubation of current hospitalization
Key exclusion criteria (24 listed)
- Patient has opted out of research participation via institutional patient portal.
- Prior upper gastrointestinal surgery that alters proximal GI anatomy (including but not limited to gastric bypass surgery, gastric banding, complete or partial gastrectomy, Whipple procedure; of note, appendectomy and cholecystectomy are not exclusion criteria.
- Structural gastrointestinal obstruction (such as tumor).
- Chronic enteral nutrition (prior to current admission).
- History of significant esophageal dysmotility (history of GERD is acceptable) or clinically significant GE junction incompetence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent feed participantPatients 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. | Dietary supplement | Intermittent feed |
| Continuous feeds participantPatients 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. | Dietary supplement | Continuous feeds |
Primary outcome
Recommended calories
Time frame: Intubation day 1 to intubation day 10
percentage of recommended calories that patient receives per day of interest during study period
8 secondary outcomes
Percentage of patients with aspiration
Time frame: Intubation day 1 to intubation day 10
Percentage of patients experiencing intolerance of feeding
Time frame: Intubation day 1 to intubation day 10
feasibility: proportion complete protocol
Time frame: Intubation day 1 to intubation day 10
delirium
Time frame: intubation day 1 until 14 days later
urine 6-sulfatoxymelatonin acrophase
Time frame: day 1 to 3 following initiation of feeds
maximum glucose
Time frame: Intubation day 1 to intubation day 10
minimum glucose
Time frame: Intubation day 1 to intubation day 10
insulin usage
Time frame: Intubation day 1 to intubation day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No. De-identified individual participant data can be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa P Knauert, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent feed participant and Continuous feeds participant in people with Enteral Feeding and Nutrition Disorders, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended calories (time frame: Intubation day 1 to intubation day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.