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COBO2: COntinuous vs BOlus Nasogastric Feeding in Mechanically Ventilated Pediatric Patients 2

Sponsor
Akron Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02566070
Collaborator
(none)
147
Enrollment
6
Locations
2
Arms
37
Actual Duration (Months)
24.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Continuous Gastric Feeding
  • Other: Bolus Gastric Feeding
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
147 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 :
Nov 1, 2015
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Time to goal feeds (TTGF) is decreased in a bolus compared to continuous gastric feeding protocol. [12 to 48 hours post enteral feeding]

    TTGF defined as time to attain goal feeds

Secondary Outcome Measures

  1. Feeding interruptions [12 to 48 hours post enteral feeding]

    measured by minutes feeds are withheld.

  2. Gastric residual volumes [12 to 48 hours post enteral feeding]

    measured in milliliters

  3. Rate of ventilator associated infections (VAI) [12 to 48 hours post enteral feeding]

    as reported by Infection Control Department.

  4. Oxygen Saturation Index [12 to 48 hours post enteral feeding]

    as calculated by [(FiO2 x Mean Airway Pressure)/SpO2]

  5. Emesis [12 to 48 hours post enteral feeding]

    as a binary yes/no event

  6. Abdominal girth [12 to 48 hours post enteral feeding]

    measured in centimeters

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shands Children's Hospital Gainesville Florida United States 32608
2 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
3 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
4 The Children's Hospital at Oklahoma University Medical Center Oklahoma City Oklahoma United States 73117
5 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
6 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Akron Children's Hospital

Investigators

  • Principal Investigator: Ann-Marie Brown, PhD, CPNP, Akron Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT02566070
Other Study ID Numbers:
  • 150311
First Posted:
Oct 1, 2015
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Akron Children's Hospital
Enteral feeding
Continuous gastric feeding
Bolus gastric feeding

Study Results

No Results Posted as of Jan 18, 2020