An interventional study of Continuous Gastric Feeding and Bolus Gastric Feeding in Dietary Modification, sponsored by Akron Children's Hospital. Completed at 6 sites in United States. Open to participants aged 1 Month to 12 Years. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Akron Children's Hospital · Not applicable, Interventional, and Treatment
This multi-center, prospective, randomized comparative effectiveness intervention study will evaluate continuous feeding (CGF) and bolus gastric feeding (BGF) protocols and their effect on delivery of prescribed nutrition and feeding intolerance in mechanically ventilated critically ill children for up through 12 hours post achievement goal feeds or exclusion from feeding protocol, whichever comes first, to a maximum of 10 days.
A significant number of children (>30%) are malnourished upon admission to the Pediatric Intensive Care Unit (PICU). In addition, critically ill children are at risk to develop new or worsened malnutrition during their PICU stay. Adequate nutritional support of critically ill children reduces mortality and morbidities, such as hospital acquired health care infections. Inadequate nutrition during hospitalization results in poor healing, increased risk for hospital acquired conditions, and prolonged length of stay, all of which contribute to increased health care costs. Even previously healthy children experiencing critical illness are at high risk for malnourishment because of increased protein and/or caloric needs at a time when oral intake is inadequate to meet their metabolic needs. A gap in the literature exists regarding the effectiveness of 2 delivery modes for gastric enteral nutrition: continuous gastric (stomach) feeding (CGF), the steady infusion of liquid nutrition is delivered at an hourly volume via an infusion pump, and bolus gastric feeding (BGF), whereby nutrition is intermittently delivered over a prescribed period of time, followed by a period of rest.
Enteral nutrition (EN, or tube feeding) in the PICU is commonly given via continuous gastric feeding. However, feeding by bolus or intermittent methods better mimics normal body function and may minimize interruptions to feedings improving nutritional intake. This study proposes to address the gap in the literature regarding the best method to deliver EN to achieve prescribed nutritional goals and avoid feeding interruptions in the mechanically ventilated, critically ill pediatric population.
This multi-center, prospective, randomized, controlled study includes children 1-month to 12-years who are on a ventilator and have EN started within 48-hours of admission. Subjects are randomized to CGF or BGF. Feeding volume is advanced in a weight-based manner every 3-hours to target volume; caloric density is then increased to goal. Feeding intolerance measures are assessed every 3-hours. Study sites are assigned to follow one of two feeding intolerance criteria to better define the measures and thresholds necessary to halt and resume feeds for safety purposes. Incidence, duration and category of feeding interruptions are recorded. Statistical significance is defined as p \< 0.05. The findings will be submitted for oral and poster presentation and manuscripts submitted for publication.
As the focus of nursing remains not on disease and cure, rather on healing and health, nutrition is embedded in this philosophy. Our vision of nursing is to put the patient in the best position to heal him or herself. Mitigating existing malnutrition and/or avoiding newly acquired nutritional deficits decreases the risk of mortality and hospital acquired adverse events in this population. This study seeks to optimize delivery of nutrition as therapy as imperative to optimize clinical and functional outcomes in the critically ill child.
Akron Children's Hospital is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CGF group will have total daily enteral nutrition requirement delivered at a constant rate via infusion over the entire 24 hour period.
Other: Continuous Gastric Feeding
BGF group will have total daily enteral nutrition requirement delivered in interval, finite volumes over the course of the 24 hour period.
Other: Bolus Gastric Feeding
Time to goal feeds (TTGF) is decreased in a bolus compared to continuous gastric feeding protocol.
TTGF defined as time to attain goal feeds
Time frame: 12 to 48 hours post enteral feeding
Feeding interruptions
measured by minutes feeds are withheld.
Time frame: 12 to 48 hours post enteral feeding
Gastric residual volumes
measured in milliliters
Time frame: 12 to 48 hours post enteral feeding
Rate of ventilator associated infections (VAI)
as reported by Infection Control Department.
Time frame: 12 to 48 hours post enteral feeding
Oxygen Saturation Index
as calculated by \[(FiO2 x Mean Airway Pressure)/SpO2\]
Time frame: 12 to 48 hours post enteral feeding
Emesis
as a binary yes/no event
Time frame: 12 to 48 hours post enteral feeding
Abdominal girth
measured in centimeters
Time frame: 12 to 48 hours post enteral feeding
Plan to share: No
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Akron Children's Hospital