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Feeding Children Nasogastrically Versus Nasojejunally While Receiving Noninvasive Positive Pressure Ventilation (FeedNIV)

Primary Purpose

Respiratory Insufficiency, Pneumonia, Aspiration, Nutrition Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Route of feeding (nasogastric vs. nasojejunal)
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Critical Care, Intubation, gastrointestinal, Child, Infant, Adolescent, Continuous positive airway pressure, Enteral Nutrition

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age under 18 years old
  • Acute respiratory failure as the indication for non-invasive ventilatory support
  • Signed consent from parent or guardian
  • Patients with a feeding tube in place who have not been fed in > 12 hours

Exclusion Criteria:

  • Immediate postoperative cardiac surgery
  • Chronic ventilatory support
  • Admission diagnosis of aspiration pneumonia
  • Known history of frequent aspiration (more than 2 previous admissions for this diagnosis)
  • Contraindication to feeding tube placement (e.g. basal skull fracture)
  • Imminent need for endotracheal intubation
  • Percutaneous gastric tube in place
  • History of Nissen fundoplication
  • Contraindication to study nutritional formulas (e.g. galactosemia)
  • Allergy to metoclopramide
  • No signed consent from parent or guardian
  • Continuous Positive Airway Pressure (CPAP) with or without pressure support administered via an endotracheal tube
  • Corrected gestational age under 38 weeks
  • Patients with a feeding tube in place who have been fed within the last 12 hours
  • Patients with a feeding tube in place in whom the PICU staff do not wish to change the position of the feeding tube (i.e. do not agree to randomize the patient's feeding tube position)

Sites / Locations

  • Montreal Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Nasojejunal feeding (control)

Nasogastric feeding (intervention)

Arm Description

Outcomes

Primary Outcome Measures

The percent goal enteral calories received while receiving NPPV
Daily percent goal calories are recorded. Also total percent goal calories over entire NPPV course.

Secondary Outcome Measures

The time required to achieve goal calories while on NPPV
The length of stay in ICU and in hospital
Episodes of clinically important gastric aspiration

Full Information

First Posted
February 22, 2011
Last Updated
July 14, 2014
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01301352
Brief Title
Feeding Children Nasogastrically Versus Nasojejunally While Receiving Noninvasive Positive Pressure Ventilation
Acronym
FeedNIV
Official Title
The Efficacy and Safety of Gastric Feeding in Critically Ill Pediatric Patients Receiving Non-invasive Positive Pressure Ventilation: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators are studying whether it is safe and effective to provide enteral nutrition to critically ill children via the nasogastric route, as opposed to the nasojejunal route, while they are receiving noninvasive positive pressure ventilation.
Detailed Description
It has been our experience that the placement of post-pyloric tubes can be difficult, and that these tubes frequently become obstructed and are difficult to replace, resulting in lost caloric intake for the patient. The population where this is most relevant is children receiving Noninvasive Positive Pressure Ventilation (NPPV). NPPV has become increasingly popular in the Pediatric Intensive Care Unit (PICU) population, due to its perception as a safe and effective alternative to mechanical ventilation via an endotracheal tube. Historically, NPPV has been used in children with chronic respiratory insufficiency, but its application for acute respiratory compromise is increasing. It has been shown to be effective in disease states associated with hypoventilation, and is now also being applied to respiratory problems leading to decreased oxygenation. Infants and children receiving noninvasive ventilation for respiratory failure, which is often infectious in origin, have significant caloric needs. However, it is our practice not to allow gastric feeding in these patients due to the fear of gastric distension and vomiting, which carries a risk of aspiration. There is no data available on the question of efficacy and safety of gastric feeding in critically-ill children supported by noninvasive ventilation. Given the ease of (re)placement, and the potential nutritional benefit of earlier feeding provided by gastric feeding, it seems clinically important to question the bias against this route of enteral nutrition in noninvasively ventilated patients. The investigators therefore propose a pilot randomized trial of gastric versus post-pyloric feeds in patients on NPPV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Pneumonia, Aspiration, Nutrition Disorders
Keywords
Critical Care, Intubation, gastrointestinal, Child, Infant, Adolescent, Continuous positive airway pressure, Enteral Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasojejunal feeding (control)
Arm Type
No Intervention
Arm Title
Nasogastric feeding (intervention)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Route of feeding (nasogastric vs. nasojejunal)
Intervention Description
Safety and efficacy of feeding nasogastrically vs. nasojejunally while receiving noninvasive positive pressure ventilation
Primary Outcome Measure Information:
Title
The percent goal enteral calories received while receiving NPPV
Description
Daily percent goal calories are recorded. Also total percent goal calories over entire NPPV course.
Time Frame
Daily up to 14 days
Secondary Outcome Measure Information:
Title
The time required to achieve goal calories while on NPPV
Time Frame
Hours (estimated up to 48 hours)
Title
The length of stay in ICU and in hospital
Time Frame
Days (estimated up to 14 and 28 days, respectively)
Title
Episodes of clinically important gastric aspiration
Time Frame
Episodes (number - up to 1 per subject)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age under 18 years old Acute respiratory failure as the indication for non-invasive ventilatory support Signed consent from parent or guardian Patients with a feeding tube in place who have not been fed in > 12 hours Exclusion Criteria: Immediate postoperative cardiac surgery Chronic ventilatory support Admission diagnosis of aspiration pneumonia Known history of frequent aspiration (more than 2 previous admissions for this diagnosis) Contraindication to feeding tube placement (e.g. basal skull fracture) Imminent need for endotracheal intubation Percutaneous gastric tube in place History of Nissen fundoplication Contraindication to study nutritional formulas (e.g. galactosemia) Allergy to metoclopramide No signed consent from parent or guardian Continuous Positive Airway Pressure (CPAP) with or without pressure support administered via an endotracheal tube Corrected gestational age under 38 weeks Patients with a feeding tube in place who have been fed within the last 12 hours Patients with a feeding tube in place in whom the PICU staff do not wish to change the position of the feeding tube (i.e. do not agree to randomize the patient's feeding tube position)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pramod Puligandla, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada

12. IPD Sharing Statement

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Feeding Children Nasogastrically Versus Nasojejunally While Receiving Noninvasive Positive Pressure Ventilation

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