Does Volume-based Enteral Feeding Improve Nutrient Delivery in Hospitalized Critically Ill Children?

Enteral Feeding Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286177
• Other study ID #: REB21-0773
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: University of Calgary
• Contact: Nicole Gilbert, BSc
• Phone: 4039906361
• Email: nicole.gilbert[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

1. 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?

2. Assess adherence of medical staff to the study protocol

3. Evaluate the timing of study enrollment and participant allocation

4. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Critical Illness
• Enteral Feeding

Intervention

Procedure:
• Volume-based EN
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 EN
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

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health services, American Society for Parenteral and Enteral Nutrition

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months
Primary	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.	Up to 12 months
Primary	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.	Up to 12 months
Primary	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.	Up to 12 months
Primary	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.	Up to 12 months
Primary	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.	Up to 12 months
Primary	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.	Semi-structured interviews will take place after PICU discharge - up to 6 months
Primary	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.	Semi-structured interviews will take place after PICU discharge - up to 6 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	Enteral feeding route use - gastric or post-pyloric	Research assistant will find this information in the electronic medical record.	Up to 12 months
Secondary	Participant height in centimeters	Height in cm will be measured at three time points - admission to PICU, discharge from PICU and discharge from hospital	Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.
Secondary	Participant weight in kilograms	Weight in kg will be measured at three time points - admission to PICU, discharge from PICU and discharge from hospital	Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.
Secondary	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	Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.
Secondary	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.	Daily throughout PICU admission up to 12 months
Secondary	Number of days on invasive ventilation	Days when a participant is being invasively ventilated will be recorded by the research assistant.	Daily throughout PICU admission up to 12 months
Secondary	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.	Up to 12 months while in PICU
Secondary	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.	Up to 12 months while in PICU
Secondary	Number of days in PICU on inotrope medications	Vasoacctive medications including but not limited to epi, norepi, dopamine	Up to 12 months while in PICU
Secondary	Number of episodes of culture positive infections	Each culture positive infection (blood stream, speutum) will be documented as a separate event.	Up to 12 months while in PICU
Secondary	PICU length of stay (days)	Number of days a participant is admitted to PICU will be recorded by the research assistant.	Up to 12 months while in PICU
Secondary	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.	Up to 12 months while admitted to any unit at ACH
Secondary	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.	Up to 12 months while in PICU
Secondary	PICU mortality	If a participant dies while admitted to ACH PICU this will be recorded.	Up to 12 months while in PICU
Secondary	Hospital mortality	During current admission	Up to 12 months while in admitted to ACH
Secondary	60-day PICU mortality	If a participant dies up to 60 days after PICU admission day 1.	Up to 60 days from admission to PICU
Secondary	60-day readmission to hospital	If a participant is readmitted within 60 days of discharge from ACH.	Up to 60 days from admission to PICU
Secondary	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.	Up to 12 months
Secondary	Admission diagnosis	reason for admission to PICU	Up to 12 months
Secondary	Admission Comorbidities	Comorbidities present at time of admission to PICU	Up to 12 months