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CompletedNCT03573453COINNUpdated Oct 16, 2026

Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients.

An interventional study of enteral nutrition in Nutrition Disorders, sponsored by Masaryk University. Completed at 1 site in Czechia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Masaryk University · Not applicable, Interventional, and Treatment

Updated Oct 16, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of the study is to compare continuous versus intermittent strategy for enteral nutrition. The study will examine if there is a difference in achieving nutritional delivery goals, tolerance and number of complications of enteral nutrition.

Read the detailed description

The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our ICU from the 1st of June 2018 to the 31st of May 2019 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Enteral nutrition will be administered via nasogastric of orogastric tube. Patients will be randomised in 2 groups. In the group of patients receiving continuous feeding will be enteral nutrition administered via enteral feeding pump for at least 16 hours par day. In the group of patients receiving intermittent feeding will be enteral nutrition administered as 30-60minutes lasting bolus via enteral feeding pump 6 times per day. Following the administration of the bolus the patient will be placed for 30 minutes in semi-upright sitting position. Enteral nutrition requirement and composition will be standardised with the adoption of international guidelines. In 5 subsequent days from the enteral nutrition commencement will be examined if there is a difference in achieving energy and protein targets, tolerance and number of complications of enteral nutrition in between both groups. As achievement of energy and protein targets will be considered at least 80% of calculated values. The tolerance of enteral nutrition will be evaluated by the clinical examination of the abdomen, presence of diarrhoea, vomiting and the gastric residual volume of at least 0,5 liter. As the complications of enteral nutrition will be regarded the aspiration of gastric contents and ventilator associated pneumonia. Nutritional status parameters will be analysed. the length of hospital stay, ICU length of stay and 28-day mortality will be also monitored.

02

Conditions studied

  • Nutrition Disorders

Keywords

  • Critical Care
  • Enteral Nutrition
  • Ventilator Associated Pneumonia
  • Gastric Residual Volume
03

In context

Nutrition Disorders

279 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.

This study's enrollment of 300 is above the median of 115 across 198 interventional studies indexed under Nutrition Disorders.

Browse Nutrition Disorders studies →

Lead sponsor

Masaryk University is the lead sponsor of 45 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • age between 18 - 80 years
  • indication of enteral nutrition with nasogastric or orogastric tube
  • Nutrition Risk in the Critically Ill (NUTRIC) score ≥5
  • Body mass index between 18 - 50
  • mechanical ventilation expected for at least 72 hours

Exclusion criteria

Exclusion Criteria:

  • upper gastrointestinal tract surgery in previous medical history
  • bowel obstruction
  • bowel ischemia
  • acute pancreatitis
  • severe diarrhoea (>1l/24hours)
  • gastrointestinal bleeding
  • short bowel syndrome
  • malabsorption syndrome in previous medical history
  • ongoing enteral nutrition on admission to ICU
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Intermittent

    enteral nutrition will be administered via enteral feeding pump as 30-60minutes lasting bolus 6 times per day volume of initial bolus will be 80ml. The volume of bolus will be increased gradually according to tolerance, till the estimated target rate will be reached

    Other: enteral nutrition

  • Experimental
    Continuous

    enteral nutrition will be administered via enteral feeding pump for at least 16 hours par day initial rate will be 25ml/hour. The rate will be increased gradually according to tolerance, till the estimated target rate will be reached

    Other: enteral nutrition

Interventions

  • Otherenteral nutrition

    administration of enteral nutrition

06

What researchers measure

Primary outcomes

  1. Energy target

    Daily assessment of energy intake in critically ill patients with enteral nutrition.Energy target will be achieved if at least 80% of calculated energy intake will be delivered.

    Time frame: 5 days from initiation of enteral nutrition

Secondary outcomes

  1. Protein target

    Daily assessment of protein intake in critically ill patients with enteral nutrition.Protein target will be achieved if at least 80% of calculated protein intake will be delivered.

    Time frame: 5 days from initiation of enteral nutrition

  2. Tolerance of enteral nutrition

    Measurement of the gastric residual volume

    Time frame: 5 days from initiation of enteral nutrition

  3. Tolerance of enteral nutrition

    Incidence of diarrhoea

    Time frame: 5 days from initiation of enteral nutrition

  4. Tolerance of enteral nutrition

    Incidence of vomiting

    Time frame: 5 days from initiation of enteral nutrition

  5. Complications of enteral nutrition

    Incidence of aspiration and ventilator associated pneumonia

    Time frame: 5 days from initiation of enteral nutrition

  6. Nutritional status

    Blood test : total serum protein test

    Time frame: On admission and day 5 from initiation of enteral nutrition

  7. Nutritional status

    Blood test : albumin test

    Time frame: On admission and day 5 from initiation of enteral nutrition

  8. Nutritional status

    Blood test : prealbumin test

    Time frame: On admission and day 5 from initiation of enteral nutrition

Other outcomes

  1. ICU and hospital length of stay

    Time frame: through study completion, an average of 3 weeks

  2. 28-day mortality

    Time frame: 28 days from randomisation

07

Study locations

1 site
  • University Hospital Brno and Masaryk University Brno
    Brno, 62500, Czechia
08

References and documents

Publications

  • Hrdy O, Vrbica K, Strazevska E, Suk P, Souckova L, Stepanova R, Sas I, Gal R. Comparison of continuous versus intermittent enteral nutrition in critically ill patients (COINN): study protocol for a randomized comparative effectiveness trial. Trials. 2020 Nov 23;21(1):955. doi: 10.1186/s13063-020-04866-2. PubMed 33228772 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in Dec 2022, 48 months.

Of 73 non-industry interventional studies with no phase under Nutrition Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 41. This study's 48 months is above that.

Counting every sponsor, half of 77 studies reached it within 15 months; a quarter within 8 and three quarters within 36.

Primary completion moved once since we started tracking on Sep 25, 2026: Jun 2023 → Dec 2022, on Oct 16, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2018
First posted
Jun 29, 2018
StartActual
Nov 25, 2018
Primary completionActual
Dec 17, 2022was Jun 2023
CompletionActual
Jun 14, 2023
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Status unknown→Completed
changed Oct 16, 2026
Primary completion
Jun 1, 2023→Dec 17, 2022 (actual)
Oct 16, 2026
Study completion
Jun 1, 2023→Jun 14, 2023 (actual)
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Status unknown→Completed
    Primary completion Jun 1, 2023→Dec 17, 2022 (now actual)
    Study completion Jun 1, 2023→Jun 14, 2023 (now actual)
    + 3 other changes: verification date, contact details and site details

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 ↗

10

Registry details

Key details

Study ID
NCT03573453
Lead sponsor
Masaryk University
Collaborators
Brno University Hospital
Responsible party
Sponsor
First posted
Jun 29, 2018
Start date
Nov 25, 2018
Primary completion
Dec 17, 2022
Completion
Jun 14, 2023
Last update
Oct 16, 2026

Study contacts

Roman Gal, prof MD PhD
study chair · Masaryk University Brno

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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