Clinical Trial: Feeding Children Nasogastrically Versus Nasojejunally While Receiving Noninvasive Positive Pressure Ventilation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Efficacy and Safety of Gastric Feeding in Critically Ill Pediatric Patients Receiving Non-invasive Positive Pressure Ventilation: A Pilot Study

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 Summary:

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.


Sponsor: McGill University Health Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome:

  • The time required to achieve goal calories while on NPPV [ Time Frame: Hours ]
  • The length of stay in ICU and in hospital [ Time Frame: Days ]
  • Episodes of clinically important gastric aspiration [ Time Frame: Episodes (number) ]


Information By: McGill University Health Center

Dates:
Date Received: February 22, 2011
Date Started: February 2011
Date Completion:
Last Updated: July 14, 2014
Last Verified: July 2014