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

January 14, 2020 updated by: Akron Children's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • Shands Children's Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • Ohio
      • Akron, Ohio, United States, 44308
        • Children's Hospital Medical Center of Akron
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • The Children's Hospital at Oklahoma University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 to 48 hours post enteral feeding

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akron Children's Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 150311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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