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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
Sponsor:
Information provided by (Responsible Party):
Akron Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Dietary Modification Other: Continuous Gastric Feeding Other: Bolus Gastric Feeding Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Feeding interruptions as measured by minutes feeds are withheld. [ Time Frame: 12 to 48 hours post enteral feeding ]
  2. Gastric residual volumes in milliliters [ Time Frame: 12 to 48 hours post enteral feeding ]
  3. Rate of ventilator associated infections (VAI) as reported by Infection Control Department. [ Time Frame: 12 to 48 hours post enteral feeding ]
  4. Oxygen Saturation Index as calculated by [(FiO2 x Mean Airway Pressure)/SpO2]. [ Time Frame: 12 to 48 hours post enteral feeding ]
  5. Emesis as a binary yes/no event [ Time Frame: 12 to 48 hours post enteral feeding ]
  6. Abdominal girth in centimeters [ Time Frame: 12 to 48 hours post enteral feeding ]


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Ages Eligible for Study:   1 Month to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Jennifer Pitz, MPA, CRA 330-543-8272 jpitz@chmca.org
Contact: Aris Eliades, PhD, RN 330-543-3193 AEliades@chmca.org

Locations
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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
United States, Oklahoma
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         
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: Theresa Mikhailov, MD, PhD         
Sponsors and Collaborators
Akron Children's Hospital
Investigators
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Principal Investigator: Ann-Marie Brown, PhD, CPNP Akron Children's Hospital

Publications:
Brown A-M, Forbes ML, Vitale VS, Tirodker UH, Zeller R. Effects of a gastric feeding protocol on efficiency of enteral nutrition in critically ill infants and children. ICAN: Infant, Child, & Adolescent Nutrition. 2012;4(3):175-180.
Mohr F, Steffen R. Physiology of gastrointestinal motility. In: Wyllie R, Hyams JS, Kay M, eds. Pediatric Gastrointestinal and Liver Disease. 4th ed. Philadelphia, PA: Elsevier/Saunders; 2011:39-49.
Brown A-M. A Comparison of Two Gastric Feeding Approaches in Mechanically Ventilated Pediatric Patients. Akron, OH: The University of Akron; 2014:159.

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Responsible Party: Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT02566070     History of Changes
Other Study ID Numbers: 150311
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: October 2016

Keywords provided by Akron Children's Hospital:
Enteral feeding
Continuous gastric feeding
Bolus gastric feeding