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

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McGill University

Status

Completed

Conditions

Nutrition Disorders
Pneumonia, Aspiration
Respiratory Insufficiency

Treatments

Other: Route of feeding (nasogastric vs. nasojejunal)

Study type

Interventional

Funder types

Other

Identifiers

NCT01301352
10-192-PED

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

Under 17 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

30 participants in 2 patient groups

Nasojejunal feeding (control)
No Intervention group
Nasogastric feeding (intervention)
Experimental group
Treatment:
Other: Route of feeding (nasogastric vs. nasojejunal)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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