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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 10 semi structured qualitative interviews to to assess patient experiences around deferred consent.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
A double-blinded strategy is not feasible for this study because the medical team cannot remain adequately blinded to study arms after randomization. Bedside nurses delivering EN support need to know which feeding algorithm to follow. The medical team (including PICU physicians, nurse practitioners, and dietitians) have access to patients' medical records which include current hourly infusion rates of enteral feeds so they will be able to deduce the patients' allocations. The team uses current hourly infusion rates to assess fluid balance and to make clinical decisions.
To minimize bias, the research assistant tasked with data collection will remain blinded to study allocation throughout data collection and will enter the data into the REDCap Database in a blinded fashion. After data collection and prior to data analysis, all identifying information will be saved in a separate file to ensure the Study Coordinator will be re-blinded to participant allocation during data analysis.
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Volume-based EN
Volume-based EN algorithm arm.
干预措施: Volume-based EN (Procedure)
Rate-based EN
Rate-based EN algorithm (standard of care).
干预措施: Rate-based EN (Procedure)
结局指标
主要结局
10 semi structured qualitative interviews to to assess patient experiences around deferred consent.
时间窗: 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.
Proportion of eligible subjects who provide consent/assent.
时间窗: 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.
Assess participant enrollment and recruitment will be completed by documenting the number of children who successfully initiate the study protocol.
时间窗: 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.
时间窗: 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.
The length of time it takes between randomization of eligible participants to starting the assigned feeding algorithm to obtaining consent/assent.
时间窗: 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.
10 semi structured qualitative interviews to to assess guardians/caregiver perception and experiences around deferred consent.
时间窗: 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.
Reason for participant attrition/withdraw from study.
时间窗: 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.
时间窗: Up to 12 months
The research assistant will document the study day of participant removal from the study protocol in the secure REDcap database.
次要结局
- Protein received - (daily total grams protein)(Up to 12 months)
- Participant weight in kilograms(Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.)
- Number of days in PICU on inotrope medications(Up to 12 months while in PICU)
- Admission Comorbidities(Up to 12 months)
- Calories received - (daily total kcal)(Up to 12 months)
- Enteral feeding route use - gastric or post-pyloric(Up to 12 months)
- Mid upper arm circumference in cm in children >6 months of age(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.(Daily throughout PICU admission up to 12 months)
- Number of days on invasive ventilation(Daily throughout PICU admission up to 12 months)
- Hospital length of stay (days)(Up to 12 months while admitted to any unit at ACH)
- PICU mortality(Up to 12 months while in PICU)
- 60-day PICU mortality(Up to 60 days from admission to PICU)
- PICU length of stay (days)(Up to 12 months while in PICU)
- Participant height in centimeters(Within 48 hours of PICU admission, within 48 hours of PICU discharge and within 48 hours of hospital discharge.)
- Number of episodes of culture positive infections(Up to 12 months while in PICU)
- Ventilator free days(Up to 12 months while in PICU)
- Admission diagnosis(Up to 12 months)
- Number of days in PICU on non-invasive ventilation(Up to 12 months while in PICU)
- Number of days in PICU on nasal prongs (high flow O2 or low flow O2)(Up to 12 months while in PICU)
- Hospital mortality(Up to 12 months while in admitted to ACH)
- 60-day readmission to hospital(Up to 60 days from admission to PICU)
- Pediatric Risk of Mortality score (PRISM IV)(Up to 12 months)