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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301352
First Posted: February 23, 2011
Last Update Posted: July 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allon Beck, McGill University Health Center
  Purpose
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.

Condition Intervention
Respiratory Insufficiency Pneumonia, Aspiration Nutrition Disorders Other: Route of feeding (nasogastric vs. nasojejunal)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Gastric Feeding in Critically Ill Pediatric Patients Receiving Non-invasive Positive Pressure Ventilation: A Pilot Study

Further study details as provided by Allon Beck, McGill University Health Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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) ]

Enrollment: 30
Study Start Date: February 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Pramod Puligandla, MD McGill University Health Center
  More Information

Publications:
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Barr J, Hecht M, Flavin KE, Khorana A, Gould MK. Outcomes in critically ill patients before and after the implementation of an evidence-based nutritional management protocol. Chest. 2004 Apr;125(4):1446-57.
Binnekade JM, Tepaske R, Bruynzeel P, Mathus-Vliegen EM, de Hann RJ. Daily enteral feeding practice on the ICU: attainment of goals and interfering factors. Crit Care. 2005 Jun;9(3):R218-25. Epub 2005 Mar 22.
Braunschweig CL, Levy P, Sheean PM, Wang X. Enteral compared with parenteral nutrition: a meta-analysis. Am J Clin Nutr. 2001 Oct;74(4):534-42.
Cahill NE, Dhaliwal R, Day AG, Jiang X, Heyland DK. Nutrition therapy in the critical care setting: what is "best achievable" practice? An international multicenter observational study. Crit Care Med. 2010 Feb;38(2):395-401. doi: 10.1097/CCM.0b013e3181c0263d.
Casaer MP, Mesotten D, Schetz MR. Bench-to-bedside review: metabolism and nutrition. Crit Care. 2008;12(4):222. doi: 10.1186/cc6945. Epub 2008 Aug 19. Review.
Essouri S, Durand P, Chevret L, Haas V, Perot C, Clement A, Devictor D, Fauroux B. Physiological effects of noninvasive positive ventilation during acute moderate hypercapnic respiratory insufficiency in children. Intensive Care Med. 2008 Dec;34(12):2248-55. doi: 10.1007/s00134-008-1202-9. Epub 2008 Aug 19.
Esteban A, Frutos-Vivar F, Ferguson ND, Arabi Y, Apezteguía C, González M, Epstein SK, Hill NS, Nava S, Soares MA, D'Empaire G, Alía I, Anzueto A. Noninvasive positive-pressure ventilation for respiratory failure after extubation. N Engl J Med. 2004 Jun 10;350(24):2452-60.
Gramlich L, Kichian K, Pinilla J, Rodych NJ, Dhaliwal R, Heyland DK. Does enteral nutrition compared to parenteral nutrition result in better outcomes in critically ill adult patients? A systematic review of the literature. Nutrition. 2004 Oct;20(10):843-8. Review.
Greenough A. Role of ventilation in RSV disease: CPAP, ventilation, HFO, ECMO. Paediatr Respir Rev. 2009 Jun;10 Suppl 1:26-8. doi: 10.1016/S1526-0542(09)70012-0. Review.
Griffiths RD. Is parenteral nutrition really that risky in the intensive care unit? Curr Opin Clin Nutr Metab Care. 2004 Mar;7(2):175-81. Review.
Griffiths RD, Bongers T. Nutrition support for patients in the intensive care unit. Postgrad Med J. 2005 Oct;81(960):629-36. Review.
Gurgueira GL, Leite HP, Taddei JA, de Carvalho WB. Outcomes in a pediatric intensive care unit before and after the implementation of a nutrition support team. JPEN J Parenter Enteral Nutr. 2005 May-Jun;29(3):176-85.
Hadfield RJ, Sinclair DG, Houldsworth PE, Evans TW. Effects of enteral and parenteral nutrition on gut mucosal permeability in the critically ill. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 1):1545-8.
Hernandez G, Velasco N, Wainstein C, Castillo L, Bugedo G, Maiz A, Lopez F, Guzman S, Vargas C. Gut mucosal atrophy after a short enteral fasting period in critically ill patients. J Crit Care. 1999 Jun;14(2):73-7.
Heyland DK, Cook DJ, Dodek PM. Prevention of ventilator-associated pneumonia: current practice in Canadian intensive care units. J Crit Care. 2002 Sep;17(3):161-7.
Heyland DK, Dhaliwal R, Drover JW, Gramlich L, Dodek P; Canadian Critical Care Clinical Practice Guidelines Committee. Canadian clinical practice guidelines for nutrition support in mechanically ventilated, critically ill adult patients. JPEN J Parenter Enteral Nutr. 2003 Sep-Oct;27(5):355-73.
Heyland DK, Drover JW, MacDonald S, Novak F, Lam M. Effect of postpyloric feeding on gastroesophageal regurgitation and pulmonary microaspiration: results of a randomized controlled trial. Crit Care Med. 2001 Aug;29(8):1495-501.
Ho KM, Dobb GJ, Webb SA. A comparison of early gastric and post-pyloric feeding in critically ill patients: a meta-analysis. Intensive Care Med. 2006 May;32(5):639-49. Epub 2006 Mar 29. Review.
Jabbar A, McClave SA. Pre-pyloric versus post-pyloric feeding. Clin Nutr. 2005 Oct;24(5):719-26. Review.
Joshi G, Tobias JD. A five-year experience with the use of BiPAP in a pediatric intensive care unit population. J Intensive Care Med. 2007 Jan-Feb;22(1):38-43.
Kallet RH, Diaz JV. The physiologic effects of noninvasive ventilation. Respir Care. 2009 Jan;54(1):102-15.
Kawati R, Rubertsson S. Malpositioning of fine bore feeding tube: a serious complication. Acta Anaesthesiol Scand. 2005 Jan;49(1):58-61.
Marik PE, Zaloga GP. Gastric versus post-pyloric feeding: a systematic review. Crit Care. 2003 Jun;7(3):R46-51. Epub 2003 May 6. Review.
Mayordomo-Colunga J, Medina A, Rey C, Díaz JJ, Concha A, Los Arcos M, Menéndez S. Predictive factors of non invasive ventilation failure in critically ill children: a prospective epidemiological study. Intensive Care Med. 2009 Mar;35(3):527-36. doi: 10.1007/s00134-008-1346-7. Epub 2008 Nov 4.
McClave SA, DeMeo MT, DeLegge MH, DiSario JA, Heyland DK, Maloney JP, Metheny NA, Moore FA, Scolapio JS, Spain DA, Zaloga GP. North American Summit on Aspiration in the Critically Ill Patient: consensus statement. JPEN J Parenter Enteral Nutr. 2002 Nov-Dec;26(6 Suppl):S80-5. Review.
Meert KL, Daphtary KM, Metheny NA. Gastric vs small-bowel feeding in critically ill children receiving mechanical ventilation: a randomized controlled trial. Chest. 2004 Sep;126(3):872-8.
Metheny NA. Preventing respiratory complications of tube feedings: evidence-based practice. Am J Crit Care. 2006 Jul;15(4):360-9. Review.
Montejo JC, Grau T, Acosta J, Ruiz-Santana S, Planas M, García-De-Lorenzo A, Mesejo A, Cervera M, Sánchez-Alvarez C, Núñez-Ruiz R, López-Martínez J; Nutritional and Metabolic Working Group of the Spanish Society of Intensive Care Medicine and Coronary Units. Multicenter, prospective, randomized, single-blind study comparing the efficacy and gastrointestinal complications of early jejunal feeding with early gastric feeding in critically ill patients. Crit Care Med. 2002 Apr;30(4):796-800.
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Neumann DA, DeLegge MH. Gastric versus small-bowel tube feeding in the intensive care unit: a prospective comparison of efficacy. Crit Care Med. 2002 Jul;30(7):1436-8.
Niv E, Fireman Z, Vaisman N. Post-pyloric feeding. World J Gastroenterol. 2009 Mar 21;15(11):1281-8. Review.
Scolapio JS. Decreasing aspiration risk with enteral feeding. Gastrointest Endosc Clin N Am. 2007 Oct;17(4):711-6. Review.
Teague WG. Noninvasive ventilation in the pediatric intensive care unit for children with acute respiratory failure. Pediatr Pulmonol. 2003 Jun;35(6):418-26. Review.
Teague WG. Non-invasive positive pressure ventilation: current status in paediatric patients. Paediatr Respir Rev. 2005 Mar;6(1):52-60. Review.
Thurley PD, Hopper MA, Jobling JC, Teahon K. Fluoroscopic insertion of post-pyloric feeding tubes: success rates and complications. Clin Radiol. 2008 May;63(5):543-8. doi: 10.1016/j.crad.2007.11.005. Epub 2008 Feb 6.
Wernerman J. Intensive care unit nutrition -- nonsense or neglect? Crit Care. 2005 Jun;9(3):251-2. Epub 2005 Apr 20.
White H, Sosnowski K, Tran K, Reeves A, Jones M. A randomised controlled comparison of early post-pyloric versus early gastric feeding to meet nutritional targets in ventilated intensive care patients. Crit Care. 2009;13(6):R187. doi: 10.1186/cc8181. Epub 2009 Nov 25.

Responsible Party: Allon Beck, Dr., McGill University Health Center
ClinicalTrials.gov Identifier: NCT01301352     History of Changes
Other Study ID Numbers: 10-192-PED
First Submitted: February 22, 2011
First Posted: February 23, 2011
Last Update Posted: July 16, 2014
Last Verified: July 2014

Keywords provided by Allon Beck, McGill University Health Center:
Critical Care
Intubation, gastrointestinal
Child
Infant
Adolescent
Continuous positive airway pressure
Enteral Nutrition

Additional relevant MeSH terms:
Pneumonia
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Nutrition Disorders
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases


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