Feeding Children Nasogastrically Versus Nasojejunally While Receiving Noninvasive Positive Pressure Ventilation

Not Applicable

Completed

• Conditions: Respiratory Insufficiency; Nutrition Disorders; Pneumonia, Aspiration
• Interventions: Other: Route of feeding (nasogastric vs. nasojejunal)

• Registration Number: NCT01301352
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nasogastric feeding (intervention)	Route of feeding (nasogastric vs. nasojejunal)	-

Primary Outcome Measures

Name	Time	Method
The percent goal enteral calories received while receiving NPPV	Daily up to 14 days	Daily percent goal calories are recorded. Also total percent goal calories over entire NPPV course.

Secondary Outcome Measures

Name	Time	Method
The time required to achieve goal calories while on NPPV	Hours (estimated up to 48 hours)
The length of stay in ICU and in hospital	Days (estimated up to 14 and 28 days, respectively)
Episodes of clinically important gastric aspiration	Episodes (number - up to 1 per subject)

Trial Locations

Locations (1)

Montreal Children's Hospital; 🇨🇦 Montreal, Quebec, Canada