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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01301352
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):
Allon Beck, McGill University Health Center

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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Pneumonia, Aspiration Nutrition Disorders Other: Route of feeding (nasogastric vs. nasojejunal) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Gastric Feeding in Critically Ill Pediatric Patients Receiving Non-invasive Positive Pressure Ventilation: A Pilot Study
Study Start Date : February 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
No Intervention: Nasojejunal feeding (control)
Experimental: Nasogastric feeding (intervention) Other: Route of feeding (nasogastric vs. nasojejunal)
Safety and efficacy of feeding nasogastrically vs. nasojejunally while receiving noninvasive positive pressure ventilation

Primary Outcome Measures :
  1. The percent goal enteral calories received while receiving NPPV [ Time Frame: Daily up to 14 days ]
    Daily percent goal calories are recorded. Also total percent goal calories over entire NPPV course.

Secondary Outcome Measures :
  1. The time required to achieve goal calories while on NPPV [ Time Frame: Hours (estimated up to 48 hours) ]
  2. The length of stay in ICU and in hospital [ Time Frame: Days (estimated up to 14 and 28 days, respectively) ]
  3. Episodes of clinically important gastric aspiration [ Time Frame: Episodes (number - up to 1 per subject) ]

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT01301352

Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Pramod Puligandla, MD McGill University Health Center


Responsible Party: Allon Beck, Dr., McGill University Health Center Identifier: NCT01301352     History of Changes
Other Study ID Numbers: 10-192-PED
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Keywords provided by Allon Beck, McGill University Health Center:
Critical Care
Intubation, gastrointestinal
Continuous positive airway pressure
Enteral Nutrition

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Nutrition Disorders
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases