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Trial record 6 of 10 for:    "Pneumonia, Aspiration"
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Feeding Children Nasogastrically Versus Nasojejunally While Receiving Noninvasive Positive Pressure Ventilation (FeedNIV)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01301352
First received: February 22, 2011
Last updated: March 4, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention
Respiratory Insufficiency
Pneumonia, Aspiration
Nutrition Disorders
 Other: Route of feeding (nasogastric vs. nasojejunal)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • The percent goal enteral calories received while receiving NPPV [ Time Frame: Daily up to 14 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Hours (estimated up to 48 hours) ] [ Designated as safety issue: No ]
  • The length of stay in ICU and in hospital [ Time Frame: Days (estimated up to 14 and 28 days, respectively) ] [ Designated as safety issue: No ]
  • Episodes of clinically important gastric aspiration [ Time Frame: Episodes (number - up to 1 per subject) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301352

Contacts
Contact: Allon Beck, MD 514-412-4400 ext 22696 allon.beck@mail.mcgill.ca
Contact: Maryse Dagenais, APN 514-412-4400 ext 23367 maryse.dagenais@muhc.mcgill.ca

Locations
Canada, Quebec
Montreal Children's Hospital Recruiting
Montreal, Quebec, Canada, H3H 1P3
Sub-Investigator: Larry Lands, MD, PhD            
Sub-Investigator: Davinia Withington, MD            
Sub-Investigator: Ana Sant'Anna, MD            
Sub-Investigator: Maryse Dagenais, APN            
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Pramod Puligandla, MD McGill University Health Center
  More Information

Publications:

Responsible Party: Dr. Pramod Puligandla, MUHC
ClinicalTrials.gov Identifier: NCT01301352     History of Changes
Other Study ID Numbers: 10-192-PED
Study First Received: February 22, 2011
Last Updated: March 4, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by McGill University Health Center:
Critical Care
Intubation, gastrointestinal
Child
Infant
 Adolescent
Continuous positive airway pressure
Enteral Nutrition

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

ClinicalTrials.gov processed this record on May 19, 2013