COntinuous vs BOlus Nasogastric Feeding in Mechanically Ventilated Pediatric Patients 2
Condition: Dietary Modification
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Continuous Gastric Feeding; Bolus Gastric Feeding
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Enteral feeding; Continuous gastric feeding; Bolus gastric feeding