Clinical trial NCT02566070: COntinuous vs BOlus Nasogastric Feeding in Mechanically Ventilated Pediatric Patients 2
Official title: COntinuous vs BOlus Nasogastric Feeding in Mechanically Ventilated Pediatric Patients 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Keywords: Enteral feeding
Continuous gastric feeding
Bolus gastric feeding
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 147
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* all medical patients hospitalized in the Pediatric Intensive Care Unit (PICU)
* aged 1 month through 12 years of age
* mechanically ventilated within the first 24 hours of admission
* patients with an anticipated duration of mechanical ventilation greater than 48 hours

Exclusion Criteria:

* diagnosis of acute or chronic gastrointestinal pathology
* primary cardiac surgery or other surgical service patients
* enteral nutrition initiated greater than 48 hours post PICU admission, or
* enteral nutrition was initiated prior to admission to PICU

Primary outcomes:
measure: Time to goal feeds (TTGF) is decreased in a bolus compared to continuous gastric feeding protocol.
timeFrame: 12 to 48 hours post enteral feeding
Secondary outcomes:
measure: Feeding interruptions
timeFrame: 12 to 48 hours post enteral feeding
measure: Gastric residual volumes
timeFrame: 12 to 48 hours post enteral feeding
measure: Rate of ventilator associated infections (VAI)
timeFrame: 12 to 48 hours post enteral feeding
measure: Oxygen Saturation Index
timeFrame: 12 to 48 hours post enteral feeding
measure: Emesis
timeFrame: 12 to 48 hours post enteral feeding
measure: Abdominal girth
timeFrame: 12 to 48 hours post enteral feeding
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Children's Hospital
state: Florida
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
city: Oklahoma City
country: United States
facility: The Children's Hospital at Oklahoma University Medical Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Akron Children's Hospital
name: Ann-Marie Brown, PhD, CPNP
role: PRINCIPAL_INVESTIGATOR
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