COntinuous vs BOlus Nasogastric Feeding in Mechanically Ventilated Pediatric Patients 2

Not Applicable

Completed

• Conditions: Dietary Modification
• Interventions: Other: Continuous Gastric Feeding; Other: Bolus Gastric Feeding

• Registration Number: NCT02566070
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Study Start: 2015-11
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Gastric Feeding (CGF)	Continuous Gastric Feeding	CGF group will have total daily enteral nutrition requirement delivered at a constant rate via infusion over the entire 24 hour period.
Bolus Gastric Feeding (BGF)	Bolus Gastric Feeding	BGF group will have total daily enteral nutrition requirement delivered in interval, finite volumes over the course of the 24 hour period.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (6)

Shands Children's Hospital; 🇺🇸 Gainesville, Florida, United States

Children's Hospital Medical Center of Akron; 🇺🇸 Akron, Ohio, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

The Children's Hospital at Oklahoma University Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States