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This multi-center, prospective, randomized comparative effectiveness intervention study will evaluate continuous feeding (CGF) and bolus gastric feeding (BGF) protocols and their effect on delivery of prescribed nutrition and feeding intolerance in mechanically ventilated critically ill children for up through 12 hours post achievement goal feeds or exclusion from feeding protocol, whichever comes first, to a maximum of 10 days.
A significant number of children (>30%) are malnourished upon admission to the Pediatric Intensive Care Unit (PICU). In addition, critically ill children are at risk to develop new or worsened malnutrition during their PICU stay. Adequate nutritional support of critically ill children reduces mortality and morbidities, such as hospital acquired health care infections. Inadequate nutrition during hospitalization results in poor healing, increased risk for hospital acquired conditions, and prolonged length of stay, all of which contribute to increased health care costs. Even previously healthy children experiencing critical illness are at high risk for malnourishment because of increased protein and/or caloric needs at a time when oral intake is inadequate to meet their metabolic needs. A gap in the literature exists regarding the effectiveness of 2 delivery modes for gastric enteral nutrition: continuous gastric (stomach) feeding (CGF), the steady infusion of liquid nutrition is delivered at an hourly volume via an infusion pump, and bolus gastric feeding (BGF), whereby nutrition is intermittently delivered over a prescribed period of time, followed by a period of rest.
Enteral nutrition (EN, or tube feeding) in the PICU is commonly given via continuous gastric feeding. However, feeding by bolus or intermittent methods better mimics normal body function and may minimize interruptions to feedings improving nutritional intake. This study proposes to address the gap in the literature regarding the best method to deliver EN to achieve prescribed nutritional goals and avoid feeding interruptions in the mechanically ventilated, critically ill pediatric population.
This multi-center, prospective, randomized, controlled study includes children 1-month to 12-years who are on a ventilator and have EN started within 48-hours of admission. Subjects are randomized to CGF or BGF. Feeding volume is advanced in a weight-based manner every 3-hours to target volume; caloric density is then increased to goal. Feeding intolerance measures are assessed every 3-hours. Study sites are assigned to follow one of two feeding intolerance criteria to better define the measures and thresholds necessary to halt and resume feeds for safety purposes. Incidence, duration and category of feeding interruptions are recorded. Statistical significance is defined as p < 0.05. The findings will be submitted for oral and poster presentation and manuscripts submitted for publication.
As the focus of nursing remains not on disease and cure, rather on healing and health, nutrition is embedded in this philosophy. Our vision of nursing is to put the patient in the best position to heal him or herself. Mitigating existing malnutrition and/or avoiding newly acquired nutritional deficits decreases the risk of mortality and hospital acquired adverse events in this population. This study seeks to optimize delivery of nutrition as therapy as imperative to optimize clinical and functional outcomes in the critically ill child.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Gastric Feeding (CGF) | Active Comparator | CGF group will have total daily enteral nutrition requirement delivered at a constant rate via infusion over the entire 24 hour period. |
|
| Bolus Gastric Feeding (BGF) | Experimental | BGF group will have total daily enteral nutrition requirement delivered in interval, finite volumes over the course of the 24 hour period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Gastric Feeding | Other |
| ||
| Bolus Gastric Feeding |
| Measure | Description | Time Frame |
|---|---|---|
| Time to goal feeds (TTGF) is decreased in a bolus compared to continuous gastric feeding protocol. | TTGF defined as time to attain goal feeds | 12 to 48 hours post enteral feeding |
| Measure | Description | Time Frame |
|---|---|---|
| Feeding interruptions | measured by minutes feeds are withheld. | 12 to 48 hours post enteral feeding |
| Gastric residual volumes | measured in milliliters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann-Marie Brown, PhD, CPNP | Akron Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands Children's Hospital | Gainesville | Florida | 32608 | United States | ||
| Dartmouth-Hitchcock Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22564954 | Background | Mehta NM, Bechard LJ, Cahill N, Wang M, Day A, Duggan CP, Heyland DK. Nutritional practices and their relationship to clinical outcomes in critically ill children--an international multicenter cohort study*. Crit Care Med. 2012 Jul;40(7):2204-11. doi: 10.1097/CCM.0b013e31824e18a8. | |
| 24403379 | Background | Mikhailov TA, Kuhn EM, Manzi J, Christensen M, Collins M, Brown AM, Dechert R, Scanlon MC, Wakeham MK, Goday PS. Early enteral nutrition is associated with lower mortality in critically ill children. JPEN J Parenter Enteral Nutr. 2014 May;38(4):459-66. doi: 10.1177/0148607113517903. Epub 2014 Jan 8. |
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| Other |
|
| 12 to 48 hours post enteral feeding |
| Rate of ventilator associated infections (VAI) | as reported by Infection Control Department. | 12 to 48 hours post enteral feeding |
| Oxygen Saturation Index | as calculated by [(FiO2 x Mean Airway Pressure)/SpO2] | 12 to 48 hours post enteral feeding |
| Emesis | as a binary yes/no event | 12 to 48 hours post enteral feeding |
| Abdominal girth | measured in centimeters | 12 to 48 hours post enteral feeding |
| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | United States |
| The Children's Hospital at Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73117 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| 19903872 | Background | Mehta NM, McAleer D, Hamilton S, Naples E, Leavitt K, Mitchell P, Duggan C. Challenges to optimal enteral nutrition in a multidisciplinary pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 2010 Jan-Feb;34(1):38-45. doi: 10.1177/0148607109348065. Epub 2009 Nov 10. |
| 20403667 | Background | Khorasani EN, Mansouri F. Effect of early enteral nutrition on morbidity and mortality in children with burns. Burns. 2010 Nov;36(7):1067-71. doi: 10.1016/j.burns.2009.12.005. Epub 2010 Apr 18. |
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| 23064254 | Background | Larsen BM, Goonewardene LA, Field CJ, Joffe AR, Van Aerde JE, Olstad DL, Clandinin MT. Low energy intakes are associated with adverse outcomes in infants after open heart surgery. JPEN J Parenter Enteral Nutr. 2013 Mar;37(2):254-60. doi: 10.1177/0148607112463075. Epub 2012 Oct 11. |
| 19398612 | Background | Mehta NM, Compher C; A.S.P.E.N. Board of Directors. A.S.P.E.N. Clinical Guidelines: nutrition support of the critically ill child. JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):260-76. doi: 10.1177/0148607109333114. No abstract available. |
| Background | Brown A-M, Forbes ML, Vitale VS, Tirodker UH, Zeller R. Effects of a gastric feeding protocol on efficiency of enteral nutrition in critically ill infants and children. ICAN: Infant, Child, & Adolescent Nutrition. 2012;4(3):175-180. |
| 22853808 | Background | Tume L, Carter B, Latten L. A UK and Irish survey of enteral nutrition practices in paediatric intensive care units. Br J Nutr. 2013 Apr 14;109(7):1304-22. doi: 10.1017/S0007114512003042. Epub 2012 Aug 1. |
| Background | Mohr F, Steffen R. Physiology of gastrointestinal motility. In: Wyllie R, Hyams JS, Kay M, eds. Pediatric Gastrointestinal and Liver Disease. 4th ed. Philadelphia, PA: Elsevier/Saunders; 2011:39-49. |
| 16967399 | Background | Chen YC, Chou SS, Lin LH, Wu LF. The effect of intermittent nasogastric feeding on preventing aspiration pneumonia in ventilated critically ill patients. J Nurs Res. 2006 Sep;14(3):167-80. doi: 10.1097/01.jnr.0000387575.66598.2a. |
| 12851181 | Background | Lee JS, Auyeung TW. A comparison of two feeding methods in the alleviation of diarrhoea in older tube-fed patients: a randomised controlled trial. Age Ageing. 2003 Jul;32(4):388-93. doi: 10.1093/ageing/32.4.388. |
| 19910085 | Background | Lee JS, Kwok T, Chui PY, Ko FW, Lo WK, Kam WC, Mok HL, Lo R, Woo J. Can continuous pump feeding reduce the incidence of pneumonia in nasogastric tube-fed patients? A randomized controlled trial. Clin Nutr. 2010 Aug;29(4):453-8. doi: 10.1016/j.clnu.2009.10.003. Epub 2009 Nov 12. |
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| 23321763 | Background | Reignier J, Mercier E, Le Gouge A, Boulain T, Desachy A, Bellec F, Clavel M, Frat JP, Plantefeve G, Quenot JP, Lascarrou JB; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Effect of not monitoring residual gastric volume on risk of ventilator-associated pneumonia in adults receiving mechanical ventilation and early enteral feeding: a randomized controlled trial. JAMA. 2013 Jan 16;309(3):249-56. doi: 10.1001/jama.2012.196377. |
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