Enteral FeedingNCT05286177
Does Volume-based Enteral Feeding Improve Nutrient Delivery in Hospitalized Critically Ill Children?
A study testing Volume-based EN and Rate-based EN in people with Enteral Feeding, run by University of Calgary at 1 site in Canada.
Trial summary
Background Some critically ill children have malnutrition which may worsen while they are in hospital and delay their return home. They can recover faster when they are given tube feedings to improve their nutrition. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Enteral Feeding
- What is being tested?
- Volume-based EN and Rate-based EN
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 20 Mar 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children 1-month post-natal age to 18 years of age
- Children anticipated by the intensivist or nurse practitioner to be admitted to the PICU for ≥ 48 hours
- Children who will be initiated on EN support
Who cannot join
- Children will not be eligible for this study if they are palliative
- Children who have contraindications to EN (i.e., a non-functional GI tract)
- Children who are on parenteral nutrition
- Children who are being fed by a bolus feed regime
- Children who cannot progress past trophic feed volumes within 24 hours of EN initiation
- Children anticipated to be admitted to PICU for <48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Volume-based Enteral Feeding Improve Nutrient Delivery in Hospitalized Critically Ill Children? A Randomized Feasibility Trial of Volume Versus Rate-based Enteral Nutrition Algorithms.
Background Some critically ill children have malnutrition which may worsen while they are in hospital and delay their return home. They can recover faster when they are given tube feedings to improve their nutrition. Unfortunately, in the hospital these feedings are often interrupted and so these children do not get all the nutrition they need. The usual procedure is to set hourly rates for the tube feedings and to accept that they get less when feedings are interrupted. The researchers would like to test if children are fed better if the bedside nurses were to check the volume provided through the day and then ensure the child gets closer to the prescribed volumes.
Aim To determine the feasibility of performing a Randomized Control Trial assessing the use of a Volume-based feeding algorithm in critically ill children admitted to the Alberta Children's Hospital Pediatric Intensive Care Unit (PICU).
Read more
Objectives
- Obtain information to inform sample size calculations for nutrition and clinical outcomes for a larger RCT: energy adequacy and protein adequacy, feed tolerance, infections, changes in anthropometric measurements at transitions of care, 28-day ventilator free days, length of stay, 60-day mortality, and 60-day hospital readmission?
- Assess adherence of medical staff to the study protocol
- Evaluate the timing of study enrollment and participant allocation
- Evaluate the proposed deferred consent strategy.
Methods The researchers will conduct a randomized control feasibility trial of critically ill children admitted to the Alberta Children's Hospital (ACH) Pediatric Intensive Care unit who require tube feedings. Children will be randomly assigned to the intervention arm (Volume-based algorithm) or the comparison arm (rate-based algorithm).
Significance The proposed study will provide evidence of whether a novel approach to feeding critically ill children is feasible during PICU admission. This trial will inform a larger Randomized Control Trial on this topic that will assess if using a Volume-based feeding algorithm will improve outcomes of clinical importance including energy adequacy, protein adequacy, feed tolerance, infections, changes in anthropometric measurements at transitions of care, 28-day ventilator free days, length of stay in PICU and hospital, 60-day mortality, and 60-day hospital readmission.
Read the detailed description
Malnutrition is prevalent in hospitalized critically ill children, may worsen throughout hospital admission, and is associated with negative outcomes including increased ventilator days and longer hospital stays. Early optimal enteral nutrition (EN) is associated with improved outcomes including reduced mortality and shorter hospital stays. Unfortunately, feed interruptions are common which result in underfeeding and accumulating nutrient deficits. Traditionally in pediatrics, tube feedings are ordered and provided using hourly rate-based EN algorithms, which direct the nurse to run the feeding pump at a prescribed hourly rate. The problem with this approach is that the nurse is not authorized to compensate for feed interruptions. Using a daily volume-based EN goal would circumvent this issue by allowing bedside nurses to adjust feedings to be able to deliver the 24-hour desired goal and compensate for feed disruptions. Research conducted in adult critical care comparing volume based versus rate based EN algorithms have shown superior energy and protein delivery. To the researchers knowledge, no pediatric studies have compared volume to rate-based EN.
Aim To determine the feasibility of performing a randomized controlled trial (RCT) assessing the use of a volume-based versus rate-based feeding algorithm in critically ill children admitted to the pediatric intensive care unit (PICU).
Objectives
The primary objective is to assess the feasibility of the proposed randomized control trial to evaluate a Volume-based EN algorithm in the PICU by:
Assessing participant enrollment and recruitment Assessing adherence of medical and nursing staff to the study protocol Evaluating the acceptability of the proposed deferred consent strategy The secondary objective will be to obtain data to inform sample size calculations for nutrition (energy and protein adequacy) and clinical outcomes (feed tolerance, infections, changes in anthropometric measurements at transitions of care, 28-day ventilator free days, length of stay, 60-day mortality, and 60-day hospital readmission) for the larger RCT.
Methods: The investigaters will conduct a single-center parallel partially-blinded 1:1 randomized feasibility trial of 20 children admitted to the Alberta Children's Hospital PICU. Children/adolescents aged 1 month to 18 years, who the investigators anticipate will be admitted to the PICU for ≥ 48 hours, and who initiate enteral nutrition support will be eligible. The trial will compare a volume-based EN algorithm (intervention) to the standard of care rate-based EN algorithm (control). Randomization will be block-stratified by age and ventilator status (invasive ventilation or other). The clinical team will remain unblinded to group allocation to be able to perform care. The research team will remain blinded to allocation to minimize bias.
Adherence to study protocol will be assessed as the number of times that medical or nursing staff deviate from the allocated feeding algorithm.
Enrollment and recruitment of participants will be evaluated by assessing the proportion of eligible participants who are successfully enrolled into the study. Reasons for non-enrollment will be recorded.
Deferred Consent: There is growing evidence that requesting consent close to admission into a PICU puts undo stress on parents/caregivers which can result in limited study enrollment. Deferred consent allows us to randomize eligible children at the time of the decision to use tube feedings and to start the study intervention prior to obtaining consent. This approach provides time to approach caregivers when they are not dealing with the fact that their child has been admitted to intensive care. As far as the investigators are aware, there is no evidence for using a deferred consent model in an enteral feeding RCT. Therefore, part of this feasibility study will assess this strategy for nutrition care research. Quantitative evaluation will be used to estimate the length of time it takes between randomization of eligible participants to starting the assigned feeding algorithm to obtaining consent/assent, the proportion of eligible subjects who provide consent/assent, and any concerns raised. Qualitative methods using the Theoretical Domains Framework will be used to assess parents' perceptions and experiences related to the deferred consent strategy using semi-structured interviews.
Baseline data collected will include age, sex, PRISM IV score (severity of illness), admission diagnosis, and admission comorbidities. Anthropometrics will be measured as soon as possible after PICU admission and at transfer to another unit and/or to home. Data for sample size estimations will be collected prospectively including daily prescribed calories and protein, daily received calories and protein, feed intolerance, deviations from assigned algorithm, ventilator days, days with inotropic support, and length of stay and mortality at PICU and hospital discharge will be collected.
- Conditions
- Enteral Feeding
- Being tested
- Volume-based EN, Rate-based EN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume-based ENProcedure or surgery
Bedside nurses will receive a total daily feed volume prescription to be administered to the participant over a 24-hour period. The bedside nurse will calculate the initial hourly rate by dividing the total daily feed goal by 24 hours at approximately 0700 hours. In this intervention group, they will be instructed to titrate the rate of feeds to accommodate for any feeding interruptions as follows: When feeds are held for > 1 hour, the remaining daily feed volume will be divided by the remaining number of hours. A maximum infusion rate will be set at 2 times the patient's baseline 24-hour feed rate to ensure that a large bolus volume of feed is not administered over a too short period of time.
Rate-based ENProcedure or surgery
Bedside nurses will receive an hourly feed rate prescription to administer the tube feedings over a 24-hour period. If feeds are held, they will be restarted at the same consistent hourly rate that was previously ordered. Nurses will not adjust feed rates to compensate for feed interruptions
| Study group | Role | What they receive |
|---|---|---|
| Volume-based EN | Experimental | Volume-based EN algorithm arm. Receives: Procedure: Volume-based EN |
| Rate-based EN | Active comparator | Rate-based EN algorithm (standard of care). Receives: Procedure: Rate-based EN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess participant enrollment and recruitment will be completed by documenting the number of children who successfully initiate the study protocol.
The investigators will evaluate the proposed inclusion/exclusion criteria, participant recruitment, and enrollment. On weekdays, during bedside rounds, the study coordinator will assess eligibility of admitted children against the inclusion/exclusion criteria. On Mondays the Study Coordinator will compare patients who were admitted over the weekend with the inclusion/exclusion criteria. After randomization, the number of children The investigators will evaluate the proposed inclusion/exclusion criteria, participant recruitment, and enrollment.
Measured: Up to 12 months
Number of deviations from assigned feeding algorithm.
The Research Assistant will document if a deviation from the allocated feeding algorithm (volume-based or rate-based) occurred in the study database daily while participants are being fed via the research protocol.
Measured: Up to 12 months
Reason for participant attrition/withdraw from study.
The research assistant will document the reason for participant removal from the study protocol in the secure REDcap database.
Measured: Up to 12 months
Day of participant attrition/withdraw from study.
The research assistant will document the study day of participant removal from the study protocol in the secure REDcap database.
Measured: Up to 12 months
The length of time it takes between randomization of eligible participants to starting the assigned feeding algorithm to obtaining consent/assent.
The time that randomization of an eligible participant occurs and the time that the participant starts the assigned feeding alogirhtm and the time that the Research Coordinator obtains consent/assent will be recorded.
Measured: Up to 12 months
Proportion of eligible subjects who provide consent/assent.
The number of eligible subjects who provided consent/assent and the number who declined consent/assent will be recorded and used to assess the proportion of subjects who provide consent.
Measured: Up to 12 months
10 semi structured qualitative interviews to to assess guardians/caregiver perception and experiences around deferred consent.
Participants will be selected through purposive sampling of parents/guardians of patients enrolled in both arms of the EN trial. Zoom semi-structured interviews will be conducted. Interviews will be recorded for data analysis. A minimum sample size for interviews set a-priori will be 10, with additional interviews theme saturation in reached. Data collection will be stopped once no new themes emerge.
Measured: Semi-structured interviews will take place after PICU discharge - up to 6 months
10 semi structured qualitative interviews to to assess patient experiences around deferred consent.
Participants will be selected through purposive sampling of patients enrolled in both arms of the EN trial. Zoom semi-structured interviews will be conducted. Interviews will be recorded for data analysis. A minimum sample size for interviews set a-priori will be 10, with additional interviews theme saturation in reached. Data collection will be stopped once no new themes emerge.
Measured: Semi-structured interviews will take place after PICU discharge - up to 6 months
Secondary outcomes (22)
Calories received - (daily total kcal)
This will be used to calculate energy adequacy by dividing daily total calories recieved by prescribed energy goal based on WHO BMR equations or indirect calorimetry.
Measured: Up to 12 months
Protein received - (daily total grams protein)
This will be used to calculate protein adequacy by dividing daily total grams protein received by goal prescribed protein based on CCSM/ASPEN guidelines.
Measured: Up to 12 months
Enteral feeding route use - gastric or post-pyloric
Research assistant will find this information in the electronic medical record.
Measured: Up to 12 months
Participant height in centimeters
Height in cm will be measured at three time points - admission to PICU, discharge from PICU and discharge from hospital
Measured: Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.
Participant weight in kilograms
Weight in kg will be measured at three time points - admission to PICU, discharge from PICU and discharge from hospital
Measured: Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.
Mid upper arm circumference in cm in children >6 months of age
MUAC will be measured at three time points - admission to PICU, discharge from PICU and discharge from hospital
Measured: Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.
Number of days of PICU admission when feed intolerance occurs will be recorded.
Feed intolerance in a 24-hour period will be defined as new onset >2 episodes of diarrhea, >2 episodes of emesis, and/or abdominal distention that results in holding feeds.
Measured: Daily throughout PICU admission up to 12 months
Number of days on invasive ventilation
Days when a participant is being invasively ventilated will be recorded by the research assistant.
Measured: Daily throughout PICU admission up to 12 months
Number of days in PICU on non-invasive ventilation
Days when a participant is on non-invasive ventilatory support will be recorded by the research assistant.
Measured: Up to 12 months while in PICU
Number of days in PICU on nasal prongs (high flow O2 or low flow O2)
Days when a participant is on high flow O2 or low flow O2 will be recorded by the research assistant.
Measured: Up to 12 months while in PICU
Number of days in PICU on inotrope medications
Vasoacctive medications including but not limited to epi, norepi, dopamine
Measured: Up to 12 months while in PICU
Number of episodes of culture positive infections
Each culture positive infection (blood stream, speutum) will be documented as a separate event.
Measured: Up to 12 months while in PICU
PICU length of stay (days)
Number of days a participant is admitted to PICU will be recorded by the research assistant.
Measured: Up to 12 months while in PICU
Hospital length of stay (days)
Number of days a participant is admitted to the Alberta Children's Hospital will be recorded by the research assistant.
Measured: Up to 12 months while admitted to any unit at ACH
Ventilator free days
The number of ventilator free days, defined as days alive and free from invasive ventilation, will be collected from PICU admission to 28 days after admission.
Measured: Up to 12 months while in PICU
PICU mortality
If a participant dies while admitted to ACH PICU this will be recorded.
Measured: Up to 12 months while in PICU
Hospital mortality
During current admission
Measured: Up to 12 months while in admitted to ACH
60-day PICU mortality
If a participant dies up to 60 days after PICU admission day 1.
Measured: Up to 60 days from admission to PICU
60-day readmission to hospital
If a participant is readmitted within 60 days of discharge from ACH.
Measured: Up to 60 days from admission to PICU
Pediatric Risk of Mortality score (PRISM IV)
PRISM IV score is a severity of illness score which is calculated at admission to PICU. PRISM IV provides a prediction of mortality and as the score increases chance of mortality increases.
Measured: Up to 12 months
Admission diagnosis
reason for admission to PICU
Measured: Up to 12 months
Admission Comorbidities
Comorbidities present at time of admission to PICU
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start20 Mar 2024
- Primary completion30 Nov 2024
- Study completionApr 2027 (estimated)
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 University of CalgaryThe 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
- Model description
- The investigators will conduct a single-center parallel partially blinded 1:1 randomized feasibility trial of 20 children admitted to the Alberta Children's Hospital (ACH) PICU.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Parenteral and Enteral Nutrition, Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Tanis Fenton, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286177
- Sponsor's protocol ID
- REB21-0773
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Volume-based Enteral Feeding Improve Nutrient Delivery in Hospitalized Critically Ill Children? A Randomized Feasibility Trial of Volume Versus Rate-based Enteral Nutrition Algorithms.
- ClinicalTrials.gov ID
- NCT05286177
- Acronym / sponsor ID
- REB21-0773
- Conditions
- Enteral Feeding
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- American Society for Parenteral and Enteral Nutrition, Alberta Health services
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 18 Mar 2022 (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.
Background Some critically ill children have malnutrition which may worsen while they are in hospital and delay their return home. They can recover faster when they are given tube feedings to improve their nutrition. Unfortunately, in the hospital these feedings are often interrupted and so these children do not get all the nutrition they need. The usual procedure is to set hourly rates for the tube feedings and to accept that they get less when feedings are interrupted. The researchers would like to test if children are fed better if the bedside nurses were to check the volume provided through the day and then ensure the child gets closer to the prescribed volumes.
Aim To determine the feasibility of performing a Randomized Control Trial assessing the use of a Volume-based feeding algorithm in critically ill children admitted to the Alberta Children's Hospital Pediatric Intensive Care Unit (PICU).
Objectives
- Obtain information to inform sample size calculations for nutrition and clinical outcomes for a larger RCT: energy adequacy and protein adequacy, feed tolerance, infections, changes in anthropometric measurements at transitions of care, 28-day ventilator free days, length of stay, 60-day mortality, and 60-day hospital readmission?
- Assess adherence of medical staff to the study protocol
- Evaluate the timing of study enrollment and participant allocation
- Evaluate the proposed deferred consent strategy.
Methods The researchers will conduct a randomized control feasibility trial of critically ill children admitted to the Alberta Children's Hospital (ACH) Pediatric Intensive Care unit who require tube feedings. Children will be randomly assigned to the intervention arm (Volume-based algorithm) or the comparison arm (rate-based algorithm).
Significance The proposed study will provide evidence of whether a novel approach to feeding critically ill children is feasible during PICU admission. This trial will inform a larger Randomized Control Trial on this topic that will assess if using a Volume-based feeding algorithm will improve outcomes of clinical importance including energy adequacy, protein adequacy, feed tolerance, infections, changes in anthropometric measurements at transitions of care, 28-day ventilator free days, length of stay in PICU and hospital, 60-day mortality, and 60-day hospital readmission.
Detailed description
Malnutrition is prevalent in hospitalized critically ill children, may worsen throughout hospital admission, and is associated with negative outcomes including increased ventilator days and longer hospital stays. Early optimal enteral nutrition (EN) is associated with improved outcomes including reduced mortality and shorter hospital stays. Unfortunately, feed interruptions are common which result in underfeeding and accumulating nutrient deficits. Traditionally in pediatrics, tube feedings are ordered and provided using hourly rate-based EN algorithms, which direct the nurse to run the feeding pump at a prescribed hourly rate. The problem with this approach is that the nurse is not authorized to compensate for feed interruptions. Using a daily volume-based EN goal would circumvent this issue by allowing bedside nurses to adjust feedings to be able to deliver the 24-hour desired goal and compensate for feed disruptions. Research conducted in adult critical care comparing volume based versus rate based EN algorithms have shown superior energy and protein delivery. To the researchers knowledge, no pediatric studies have compared volume to rate-based EN.
Aim To determine the feasibility of performing a randomized controlled trial (RCT) assessing the use of a volume-based versus rate-based feeding algorithm in critically ill children admitted to the pediatric intensive care unit (PICU).
Objectives
The primary objective is to assess the feasibility of the proposed randomized control trial to evaluate a Volume-based EN algorithm in the PICU by:
Assessing participant enrollment and recruitment Assessing adherence of medical and nursing staff to the study protocol Evaluating the acceptability of the proposed deferred consent strategy The secondary objective will be to obtain data to inform sample size calculations for nutrition (energy and protein adequacy) and clinical outcomes (feed tolerance, infections, changes in anthropometric measurements at transitions of care, 28-day ventilator free days, length of stay, 60-day mortality, and 60-day hospital readmission) for the larger RCT.
Methods: The investigaters will conduct a single-center parallel partially-blinded 1:1 randomized feasibility trial of 20 children admitted to the Alberta Children's Hospital PICU. Children/adolescents aged 1 month to 18 years, who the investigators anticipate will be admitted to the PICU for ≥ 48 hours, and who initiate enteral nutrition support will be eligible. The trial will compare a volume-based EN algorithm (intervention) to the standard of care rate-based EN algorithm (control). Randomization will be block-stratified by age and ventilator status (invasive ventilation or other). The clinical team will remain unblinded to group allocation to be able to perform care. The research team will remain blinded to allocation to minimize bias.
Adherence to study protocol will be assessed as the number of times that medical or nursing staff deviate from the allocated feeding algorithm.
Enrollment and recruitment of participants will be evaluated by assessing the proportion of eligible participants who are successfully enrolled into the study. Reasons for non-enrollment will be recorded.
Deferred Consent: There is growing evidence that requesting consent close to admission into a PICU puts undo stress on parents/caregivers which can result in limited study enrollment. Deferred consent allows us to randomize eligible children at the time of the decision to use tube feedings and to start the study intervention prior to obtaining consent. This approach provides time to approach caregivers when they are not dealing with the fact that their child has been admitted to intensive care. As far as the investigators are aware, there is no evidence for using a deferred consent model in an enteral feeding RCT. Therefore, part of this feasibility study will assess this strategy for nutrition care research. Quantitative evaluation will be used to estimate the length of time it takes between randomization of eligible participants to starting the assigned feeding algorithm to obtaining consent/assent, the proportion of eligible subjects who provide consent/assent, and any concerns raised. Qualitative methods using the Theoretical Domains Framework will be used to assess parents' perceptions and experiences related to the deferred consent strategy using semi-structured interviews.
Baseline data collected will include age, sex, PRISM IV score (severity of illness), admission diagnosis, and admission comorbidities. Anthropometrics will be measured as soon as possible after PICU admission and at transfer to another unit and/or to home. Data for sample size estimations will be collected prospectively including daily prescribed calories and protein, daily received calories and protein, feed intolerance, deviations from assigned algorithm, ventilator days, days with inotropic support, and length of stay and mortality at PICU and hospital discharge will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will conduct a single-center parallel partially blinded 1:1 randomized feasibility trial of 20 children admitted to the Alberta Children's Hospital (ACH) PICU.
| Arm | Type | Receives |
|---|---|---|
| Volume-based EN | Experimental | Procedure: Volume-based ENVolume-based EN algorithm arm. |
| Rate-based EN | Active comparator | Procedure: Rate-based ENRate-based EN algorithm (standard of care). |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children 1-month post-natal age to 18 years of age
- Children anticipated by the intensivist or nurse practitioner to be admitted to the PICU for ≥ 48 hours
- Children who will be initiated on EN support
Key exclusion criteria (6 listed)
- Children will not be eligible for this study if they are palliative
- Children who have contraindications to EN (i.e., a non-functional GI tract)
- Children who are on parenteral nutrition
- Children who are being fed by a bolus feed regime
- Children who cannot progress past trophic feed volumes within 24 hours of EN initiation
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 |
|---|---|---|
| Volume-based ENBedside nurses will receive a total daily feed volume prescription to be administered to the participant over a 24-hour period. The bedside nurse will calculate the initial hourly rate by dividing the total daily feed goal by 24 hours at approximately 0700 hours. In this intervention group, they will be instructed to titrate the rate of feeds to accommodate for any feeding interruptions as follows: When feeds are held for > 1 hour, the remaining daily feed volume will be divided by the remaining number of hours. A maximum infusion rate will be set at 2 times the patient's baseline 24-hour feed rate to ensure that a large bolus volume of feed is not administered over a too short period of time. | Procedure or surgery | Volume-based EN |
| Rate-based ENBedside nurses will receive an hourly feed rate prescription to administer the tube feedings over a 24-hour period. If feeds are held, they will be restarted at the same consistent hourly rate that was previously ordered. Nurses will not adjust feed rates to compensate for feed interruptions | Procedure or surgery | Rate-based EN |
Primary outcome
Assess participant enrollment and recruitment will be completed by documenting the number of children who successfully initiate the study protocol.
Time frame: Up to 12 months
The investigators will evaluate the proposed inclusion/exclusion criteria, participant recruitment, and enrollment. On weekdays, during bedside rounds, the study coordinator will assess eligibility of admitted children against the inclusion/exclusion criteria. On Mondays the Study Coordinator will compare patients who were admitted over the weekend with the inclusion/exclusion criteria. After randomization, the number of children The investigators will evaluate the proposed inclusion/exclusion criteria, participant recruitment, and enrollment.
Number of deviations from assigned feeding algorithm.
Time frame: Up to 12 months
The Research Assistant will document if a deviation from the allocated feeding algorithm (volume-based or rate-based) occurred in the study database daily while participants are being fed via the research protocol.
Reason for participant attrition/withdraw from study.
Time frame: Up to 12 months
The research assistant will document the reason for participant removal from the study protocol in the secure REDcap database.
Day of participant attrition/withdraw from study.
Time frame: Up to 12 months
The research assistant will document the study day of participant removal from the study protocol in the secure REDcap database.
The length of time it takes between randomization of eligible participants to starting the assigned feeding algorithm to obtaining consent/assent.
Time frame: Up to 12 months
The time that randomization of an eligible participant occurs and the time that the participant starts the assigned feeding alogirhtm and the time that the Research Coordinator obtains consent/assent will be recorded.
Proportion of eligible subjects who provide consent/assent.
Time frame: Up to 12 months
The number of eligible subjects who provided consent/assent and the number who declined consent/assent will be recorded and used to assess the proportion of subjects who provide consent.
10 semi structured qualitative interviews to to assess guardians/caregiver perception and experiences around deferred consent.
Time frame: Semi-structured interviews will take place after PICU discharge - up to 6 months
Participants will be selected through purposive sampling of parents/guardians of patients enrolled in both arms of the EN trial. Zoom semi-structured interviews will be conducted. Interviews will be recorded for data analysis. A minimum sample size for interviews set a-priori will be 10, with additional interviews theme saturation in reached. Data collection will be stopped once no new themes emerge.
10 semi structured qualitative interviews to to assess patient experiences around deferred consent.
Time frame: Semi-structured interviews will take place after PICU discharge - up to 6 months
Participants will be selected through purposive sampling of patients enrolled in both arms of the EN trial. Zoom semi-structured interviews will be conducted. Interviews will be recorded for data analysis. A minimum sample size for interviews set a-priori will be 10, with additional interviews theme saturation in reached. Data collection will be stopped once no new themes emerge.
22 secondary outcomes
Calories received - (daily total kcal)
Time frame: Up to 12 months
Protein received - (daily total grams protein)
Time frame: Up to 12 months
Enteral feeding route use - gastric or post-pyloric
Time frame: Up to 12 months
Participant height in centimeters
Time frame: Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.
Participant weight in kilograms
Time frame: Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.
Mid upper arm circumference in cm in children >6 months of age
Time frame: Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.
Number of days of PICU admission when feed intolerance occurs will be recorded.
Time frame: Daily throughout PICU admission up to 12 months
Number of days on invasive ventilation
Time frame: Daily throughout PICU admission up to 12 months
Number of days in PICU on non-invasive ventilation
Time frame: Up to 12 months while in PICU
Number of days in PICU on nasal prongs (high flow O2 or low flow O2)
Time frame: Up to 12 months while in PICU
Number of days in PICU on inotrope medications
Time frame: Up to 12 months while in PICU
Number of episodes of culture positive infections
Time frame: Up to 12 months while in PICU
PICU length of stay (days)
Time frame: Up to 12 months while in PICU
Hospital length of stay (days)
Time frame: Up to 12 months while admitted to any unit at ACH
Ventilator free days
Time frame: Up to 12 months while in PICU
PICU mortality
Time frame: Up to 12 months while in PICU
Hospital mortality
Time frame: Up to 12 months while in admitted to ACH
60-day PICU mortality
Time frame: Up to 60 days from admission to PICU
60-day readmission to hospital
Time frame: Up to 60 days from admission to PICU
Pediatric Risk of Mortality score (PRISM IV)
Time frame: Up to 12 months
Admission diagnosis
Time frame: Up to 12 months
Admission Comorbidities
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
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.
Tanis Fenton, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volume-based EN and Rate-based EN in people with Enteral Feeding, run by University of Calgary at 1 site in Canada.
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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Assess participant enrollment and recruitment will be completed by documenting the number of children who successfully initiate the study protocol. (time frame: Up to 12 months). The study lists 8 primary outcomes in all. 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 1 May 2026.