COntinuous vs BOlus Nasogastric Feeding in Mechanically Ventilated Pediatric Patients 2 (COBO2)
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|ClinicalTrials.gov Identifier: NCT02566070|
Recruitment Status : Unknown
Verified October 2016 by Akron Children's Hospital.
Recruitment status was: Recruiting
First Posted : October 1, 2015
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dietary Modification||Other: Continuous Gastric Feeding Other: Bolus Gastric Feeding||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||860 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||COntinuous vs BOlus Nasogastric Feeding in Mechanically Ventilated Pediatric Patients 2|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Continuous Gastric Feeding (CGF)
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
Experimental: Bolus Gastric Feeding (BGF)
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-defined as time to attain goal feeds) is decreased in a bolus compared to continuous gastric feeding protocol. [ Time Frame: 12 to 48 hours post enteral feeding ]
- Feeding interruptions as measured by minutes feeds are withheld. [ Time Frame: 12 to 48 hours post enteral feeding ]
- Gastric residual volumes 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 in centimeters [ Time Frame: 12 to 48 hours post enteral feeding ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566070
|Contact: Jennifer Pitz, MPA, CRAfirstname.lastname@example.org|
|Contact: Aris Eliades, PhD, RN||330-543-3193||AEliades@chmca.org|
|United States, Florida|
|Shands Children's Hospital||Recruiting|
|Gainesville, Florida, United States, 32608|
|Principal Investigator: Charlene Leonard, MSN, CNP|
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center||Recruiting|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator: Marcy N Singleton, ARNP|
|United States, Ohio|
|Children's Hospital Medical Center of Akron||Recruiting|
|Akron, Ohio, United States, 44308|
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|The Children's Hospital at Oklahoma University Medical Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73117|
|Contact: Christine Allen, MD 405-271-5211 Christine-Allen@ouhsc.edu|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator: Sharon Irving, PhD, ARNP|
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|Children's Hospital of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator: Theresa Mikhailov, MD, PhD|
|Principal Investigator:||Ann-Marie Brown, PhD, CPNP||Akron Children's Hospital|