Clinical trial NCT05286177: Does Volume-based Enteral Feeding Improve Nutrient Delivery in Hospitalized Critically Ill Children?
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Enteral Feeding
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: American Society for Parenteral and Enteral Nutrition
name: Alberta Health services
First posted: 2022-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess participant enrollment and recruitment will be completed by documenting the number of children who successfully initiate the study protocol.
timeFrame: Up to 12 months
measure: Number of deviations from assigned feeding algorithm.
timeFrame: Up to 12 months
measure: Reason for participant attrition/withdraw from study.
timeFrame: Up to 12 months
measure: Day of participant attrition/withdraw from study.
timeFrame: Up to 12 months
measure: The length of time it takes between randomization of eligible participants to starting the assigned feeding algorithm to obtaining consent/assent.
timeFrame: Up to 12 months
measure: Proportion of eligible subjects who provide consent/assent.
timeFrame: Up to 12 months
measure: 10 semi structured qualitative interviews to to assess guardians/caregiver perception and experiences around deferred consent.
timeFrame: Semi-structured interviews will take place after PICU discharge - up to 6 months
measure: 10 semi structured qualitative interviews to to assess patient experiences around deferred consent.
timeFrame: Semi-structured interviews will take place after PICU discharge - up to 6 months
Secondary outcomes:
measure: Calories received - (daily total kcal)
timeFrame: Up to 12 months
measure: Protein received - (daily total grams protein)
timeFrame: Up to 12 months
measure: Enteral feeding route use - gastric or post-pyloric
timeFrame: Up to 12 months
measure: Participant height in centimeters
timeFrame: Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.
measure: Participant weight in kilograms
timeFrame: Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.
measure: Mid upper arm circumference in cm in children >6 months of age
timeFrame: Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.
measure: Number of days of PICU admission when feed intolerance occurs will be recorded.
timeFrame: Daily throughout PICU admission up to 12 months
measure: Number of days on invasive ventilation
timeFrame: Daily throughout PICU admission up to 12 months
measure: Number of days in PICU on non-invasive ventilation
timeFrame: Up to 12 months while in PICU
measure: Number of days in PICU on nasal prongs (high flow O2 or low flow O2)
timeFrame: Up to 12 months while in PICU
measure: Number of days in PICU on inotrope medications
timeFrame: Up to 12 months while in PICU
measure: Number of episodes of culture positive infections
timeFrame: Up to 12 months while in PICU
measure: PICU length of stay (days)
timeFrame: Up to 12 months while in PICU
measure: Hospital length of stay (days)
timeFrame: Up to 12 months while admitted to any unit at ACH
measure: Ventilator free days
timeFrame: Up to 12 months while in PICU
measure: PICU mortality
timeFrame: Up to 12 months while in PICU
measure: Hospital mortality
timeFrame: Up to 12 months while in admitted to ACH
measure: 60-day PICU mortality
timeFrame: Up to 60 days from admission to PICU
measure: 60-day readmission to hospital
timeFrame: Up to 60 days from admission to PICU
measure: Pediatric Risk of Mortality score (PRISM IV)
timeFrame: Up to 12 months
measure: Admission diagnosis
timeFrame: Up to 12 months
measure: Admission Comorbidities
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Tanis Fenton, PhD
role: PRINCIPAL_INVESTIGATOR
References: