Feeding Children Nasogastrically Versus Nasojejunally While Receiving Noninvasive Positive Pressure Ventilation

NCT01301352 | Completed DMC

• 1 other identifier: 10-192-PED
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency; Pneumonia, Aspiration; Nutrition Disorders

Keywords

Critical Care; Intubation, gastrointestinal; Child; Infant; Adolescent; Continuous positive airway pressure; Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• The percent goal enteral calories received while receiving NPPV

  Daily percent goal calories are recorded. Also total percent goal calories over entire NPPV course.

  Daily up to 14 days

Secondary Outcomes (3)

• 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)

Study Arms (2)

Nasojejunal feeding (control)

NO INTERVENTION

Nasogastric feeding (intervention)

EXPERIMENTAL

Other: Route of feeding (nasogastric vs. nasojejunal)

Interventions

Route of feeding (nasogastric vs. nasojejunal) OTHER

Safety and efficacy of feeding nasogastrically vs. nasojejunally while receiving noninvasive positive pressure ventilation

Nasogastric feeding (intervention)

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Related Publications (39)

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MeSH Terms

Conditions

Respiratory Insufficiency; Pneumonia, Aspiration; Nutrition Disorders

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pramod Puligandla, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: February 23, 2011
• Study Start: February 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

CA (1)