An interventional study of Continuous Enteral Feeding and Intermittent Enteral Feeding in Enteral Feeding Intolerance and Critical Illness, sponsored by Viet Duc University Hospital. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Viet Duc University Hospital · Not applicable, Interventional, and Supportive care
This study will compare two commonly used methods of enteral feeding in critically ill adults: continuous feeding and intermittent feeding. The main purpose is to determine whether the amount of feeding fluid remaining in the stomach differs between the two methods.
A total of 76 participants will be randomly assigned to receive either continuous gastric feeding or intermittent gastric feeding every 4 hours. Gastric ultrasound will be performed at the bedside before starting the assigned feeding method and then every 4 hours for 72 hours. The study will also record symptoms of feeding intolerance, such as vomiting, regurgitation, abdominal distension, diarrhea, constipation, feeding interruptions, and the amount of prescribed nutrition actually delivered.
This is a single-center, prospective, open-label, parallel-group randomized controlled trial conducted in critically ill adults who require gastric enteral nutrition.
A total of 76 participants will be randomly allocated in a 1:1 ratio to continuous enteral feeding or intermittent enteral feeding. Before randomization, the treating physician, in consultation with the Department of Nutrition, will determine the enteral formula and the daily energy and protein targets for each participant. The study intervention is the method used to deliver the prescribed nutrition.
In the continuous-feeding group, the prescribed daily enteral volume will be delivered through a gastric tube using an enteral feeding pump at a stable hourly rate. In the intermittent-feeding group, the prescribed daily volume will be divided into six feeds administered every 4 hours, with each feed delivered over approximately 30 to 60 minutes.
Gastric ultrasonography will be performed at baseline before starting the assigned feeding method and every 4 hours for 72 hours. The primary outcome is the mean ultrasound-estimated gastric residual volume calculated from the 18 post-baseline measurements obtained from 4 to 72 hours. The study will also evaluate enteral feeding intolerance, vomiting or regurgitation, progressive abdominal distension, diarrhea, constipation, episodes of elevated gastric residual volume, suspected aspiration, feeding interruptions, use of prokinetic medication, and the proportion of the prescribed energy target actually delivered at 24, 48, and 72 hours.
All clinical decisions related to patient safety, including reducing, delaying, or stopping enteral feeding, will remain under the responsibility of the treating physician.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 76 is below the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Viet Duc University Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive the prescribed daily enteral nutrition continuously through a gastric tube using an enteral feeding pump. The prescribed daily volume will be delivered at a stable hourly rate calculated as the total prescribed volume for 24 hours divided by 24.
Other: Continuous Enteral Feeding
Participants assigned to this arm will receive the prescribed daily enteral nutrition through a gastric tube in six intermittent feeds administered every 4 hours. The prescribed daily volume will be divided equally among the six feeds, and each feed will be administered over approximately 30 to 60 minutes.
Other: Intermittent Enteral Feeding
The prescribed daily enteral nutrition will be delivered continuously through a gastric tube using an enteral feeding pump at a stable hourly rate. The hourly rate will be calculated as the total prescribed volume for 24 hours divided by 24.
The prescribed daily enteral nutrition will be divided into six equal feeds administered through a gastric tube every 4 hours. Each feed will be administered over approximately 30 to 60 minutes.
Mean Ultrasound-Estimated Gastric Residual Volume Over 72 Hours
Mean ultrasound-estimated gastric residual volume (GRV), in milliliters (mL). For each participant, the primary endpoint will be calculated as the arithmetic mean of 18 post-baseline GRV measurements obtained every 4 hours from 4 hours through 72 hours after initiation of the assigned feeding strategy. The baseline measurement obtained before initiation of the assigned feeding strategy will not be included in this mean. Gastric antral cross-sectional area (CSA) will be calculated as AP × CC × π/4, where AP is the anteroposterior diameter and CC is the craniocaudal diameter. GRV will be estimated using the Perlas formula: GRV (mL) = 27.0 + 14.6 × CSA (cm²) - 1.28 × age (years). Calculated values below 0 mL will be set to 0 mL.
Time frame: From 4 hours after initiation of the assigned feeding strategy through 72 hours
Participants With at Least One GRV >250 mL
Number and percentage of participants with at least one ultrasound-estimated gastric residual volume (GRV) measurement greater than 250 mL during post-baseline follow-up.
Time frame: From 4 hours after initiation of the assigned feeding strategy through 72 hours
Participants With at Least One GRV >500 mL
Number and percentage of participants with at least one ultrasound-estimated gastric residual volume (GRV) measurement greater than 500 mL during post-baseline follow-up.
Time frame: From 4 hours after initiation of the assigned feeding strategy through 72 hours
Enteral Feeding Intolerance
Number and percentage of participants with at least one gastrointestinal manifestation that causes the treating physician to reduce, delay, or temporarily interrupt enteral feeding and/or to initiate supportive treatment.
Time frame: From randomization through 72 hours
Vomiting or Regurgitation
Number and percentage of participants with at least one episode of vomiting or regurgitation documented by clinical staff during enteral feeding.
Time frame: From randomization through 72 hours
Progressive Abdominal Distension
Number and percentage of participants with new-onset abdominal distension or an increase in abdominal distension compared with the previous clinical assessment, as documented by a physician or nurse.
Time frame: From randomization through 72 hours
Diarrhea
Number and percentage of participants with diarrhea, defined as at least 3 episodes of loose stool within 24 hours or a diagnosis of diarrhea by the treating physician.
Time frame: From randomization through 72 hours
Constipation
Number and percentage of participants with constipation, defined as no bowel movement for at least 3 days or the need for therapeutic intervention for constipation during follow-up.
Time frame: From randomization through 72 hours
Suspected Pulmonary Aspiration
Number and percentage of participants with at least one clinically suspected pulmonary aspiration event documented by the treating team during enteral feeding.
Time frame: From randomization through 72 hours
Number of Enteral Feeding Reduction or Interruption Episodes
Number of episodes in which enteral feeding is reduced or temporarily interrupted during the 72-hour follow-up. The reason for each episode will be recorded.
Time frame: From randomization through 72 hours
Total Duration of Enteral Feeding Interruption
Total cumulative duration, in minutes, during which enteral feeding is temporarily interrupted during the 72-hour follow-up.
Time frame: From randomization through 72 hours
New Use of a Prokinetic Agent
Number and percentage of participants newly started on a prokinetic agent, such as metoclopramide or erythromycin, after randomization because of feeding intolerance or impaired gastric emptying.
Time frame: From randomization through 72 hours
Percentage of Prescribed Energy Target Achieved at 24 Hours
Percentage of the prescribed energy target actually delivered during the first 24 hours, calculated as cumulative actual enteral energy delivered divided by the cumulative prescribed enteral energy target for the same period, multiplied by 100.
Time frame: At 24 hours
Percentage of Prescribed Energy Target Achieved at 48 Hours
Percentage of the prescribed energy target actually delivered through 48 hours, calculated as cumulative actual enteral energy delivered divided by the cumulative prescribed enteral energy target for the same period, multiplied by 100.
Time frame: At 48 hours
Percentage of Prescribed Energy Target Achieved at 72 Hours
Percentage of the prescribed energy target actually delivered through 72 hours, calculated as cumulative actual enteral energy delivered divided by the cumulative prescribed enteral energy target for the same period, multiplied by 100.
Time frame: At 72 hours
Plan to share: No — Individual participant data will not be shared outside the approved research team. Study results will be reported in aggregate form without direct identifiers.
Started Oct 2026 (actual). Primary completion is estimated for Oct 2027, 11 months after the start.
Of 399 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 11 months is below that.
Counting every sponsor, half of 403 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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