NCT Number: NCT02566070
COntinuous vs BOlus Nasogastric Feeding in Mechanically Ventilated Pediatric Patients 2
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.
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Conditions
Age range
1 month–12 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Shands Children's Hospital, Gainesville, Florida, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Bolus Gastric Feeding
OtherPrimary outcomes
-
Time to goal feeds (TTGF) is decreased in a bolus compared to continuous gastric feeding protocol.
Time frame: 12 to 48 hours post enteral feeding
TTGF defined as time to attain goal feeds
Secondary outcomes
-
Feeding interruptions
Time frame: 12 to 48 hours post enteral feeding
measured by minutes feeds are withheld.
-
Gastric residual volumes
Time frame: 12 to 48 hours post enteral feeding
measured in milliliters
-
Rate of ventilator associated infections (VAI)
Time frame: 12 to 48 hours post enteral feeding
as reported by Infection Control Department.
-
Oxygen Saturation Index
Time frame: 12 to 48 hours post enteral feeding
as calculated by [(FiO2 x Mean Airway Pressure)/SpO2]
-
Emesis
Time frame: 12 to 48 hours post enteral feeding
as a binary yes/no event
-
Abdominal girth
Time frame: 12 to 48 hours post enteral feeding
measured in centimeters
Sponsors and collaborators
Lead sponsor
Akron Children's Hospital
Other
Registry information
Acronym: COBO2
Important dates
- Study start
- 2015
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Oct 1, 2015
- Registry last updated
- Jan 18, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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