Feeding Children Nasogastrically Versus Nasojejunally While Receiving Noninvasive Positive Pressure Ventilation (FeedNIV)
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|ClinicalTrials.gov Identifier: NCT01301352|
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : July 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Insufficiency Pneumonia, Aspiration Nutrition Disorders||Other: Route of feeding (nasogastric vs. nasojejunal)||Not Applicable|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|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
- 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.
- 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) ]
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 ClinicalTrials.gov identifier (NCT number): NCT01301352
|Montreal Children's Hospital|
|Montreal, Quebec, Canada, H3H 1P3|
|Principal Investigator:||Pramod Puligandla, MD||McGill University Health Center|