NCT02566070

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3.1 years

First QC Date

September 24, 2015

Last Update Submit

January 14, 2020

Conditions

Dietary Modification

Keywords

Enteral feedingContinuous gastric feedingBolus gastric feeding

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Feeding interruptions

    12 to 48 hours post enteral feeding

  • Gastric residual volumes

    12 to 48 hours post enteral feeding

  • Rate of ventilator associated infections (VAI)

    12 to 48 hours post enteral feeding

  • Oxygen Saturation Index

    12 to 48 hours post enteral feeding

  • Emesis

    12 to 48 hours post enteral feeding

  • +1 more secondary outcomes

Study Arms (2)

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.

Other: Continuous Gastric Feeding

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.

Other: Bolus Gastric Feeding

Interventions

Continuous Gastric FeedingOTHER
Continuous Gastric Feeding (CGF)
Bolus Gastric FeedingOTHER
Bolus Gastric Feeding (BGF)

Eligibility Criteria

Age1 Month - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all medical patients hospitalized in the Pediatric Intensive Care Unit (PICU)
  • aged 1 month through 12 years of age
  • mechanically ventilated within the first 24 hours of admission
  • patients with an anticipated duration of mechanical ventilation greater than 48 hours

You may not qualify if:

  • diagnosis of acute or chronic gastrointestinal pathology
  • primary cardiac surgery or other surgical service patients
  • enteral nutrition initiated greater than 48 hours post PICU admission, or
  • enteral nutrition was initiated prior to admission to PICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Shands Children's Hospital

Gainesville, Florida, 32608, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

The Children's Hospital at Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73117, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (25)

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    PMID: 22564954BACKGROUND

  • 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.

    PMID: 24403379BACKGROUND

  • 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.

    PMID: 19903872BACKGROUND

  • 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.

    PMID: 20403667BACKGROUND

  • Schindler CA, Mikhailov TA, Kuhn EM, Christopher J, Conway P, Ridling D, Scott AM, Simpson VS. Protecting fragile skin: nursing interventions to decrease development of pressure ulcers in pediatric intensive care. Am J Crit Care. 2011 Jan;20(1):26-34; quiz 35. doi: 10.4037/ajcc2011754.

    PMID: 21196569BACKGROUND

  • 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.

    PMID: 23064254BACKGROUND

  • 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.

    PMID: 19398612BACKGROUND

  • 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.

    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.

    PMID: 22853808BACKGROUND

  • 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.

    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.

    PMID: 16967399BACKGROUND

  • 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.

    PMID: 12851181BACKGROUND

  • 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.

    PMID: 19910085BACKGROUND

  • Horn D, Chaboyer W. Gastric feeding in critically ill children: a randomized controlled trial. Am J Crit Care. 2003 Sep;12(5):461-8.

    PMID: 14503430BACKGROUND

  • Hurt RT, McClave SA. Gastric residual volumes in critical illness: what do they really mean? Crit Care Clin. 2010 Jul;26(3):481-90, viii-ix. doi: 10.1016/j.ccc.2010.04.010.

    PMID: 20643301BACKGROUND

  • Skillman HE. Monitoring the efficacy of a PICU nutrition therapy protocol. JPEN J Parenter Enteral Nutr. 2011 Jul;35(4):445-6. doi: 10.1177/0148607111409046. Epub 2011 Jun 1. No abstract available.

    PMID: 21632953BACKGROUND

  • 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.

    PMID: 23321763BACKGROUND

  • Skillman HE. How you can improve the delivery of enteral nutrition in your PICU. JPEN J Parenter Enteral Nutr. 2010 Jan-Feb;34(1):99-100. doi: 10.1177/0148607109344725. No abstract available.

    PMID: 20054060BACKGROUND

  • Weckwerth JA. Monitoring enteral nutrition support tolerance in infants and children. Nutr Clin Pract. 2004 Oct;19(5):496-503. doi: 10.1177/0115426504019005496.

    PMID: 16215145BACKGROUND

  • Horn D, Chaboyer W, Schluter PJ. Gastric residual volumes in critically ill paediatric patients: a comparison of feeding regimens. Aust Crit Care. 2004 Aug;17(3):98-100, 102-3. doi: 10.1016/s1036-7314(04)80011-0.

    PMID: 15493856BACKGROUND

  • Cooper VB, Haut C. Preventing ventilator-associated pneumonia in children: an evidence-based protocol. Crit Care Nurse. 2013 Jun;33(3):21-9; quiz 30. doi: 10.4037/ccn2013204.

    PMID: 23727849BACKGROUND

  • Thomas NJ, Shaffer ML, Willson DF, Shih MC, Curley MA. Defining acute lung disease in children with the oxygenation saturation index. Pediatr Crit Care Med. 2010 Jan;11(1):12-7. doi: 10.1097/PCC.0b013e3181b0653d.

    PMID: 19561556BACKGROUND

  • Poulard F, Dimet J, Martin-Lefevre L, Bontemps F, Fiancette M, Clementi E, Lebert C, Renard B, Reignier J. Impact of not measuring residual gastric volume in mechanically ventilated patients receiving early enteral feeding: a prospective before-after study. JPEN J Parenter Enteral Nutr. 2010 Mar-Apr;34(2):125-30. doi: 10.1177/0148607109344745. Epub 2009 Oct 27.

    PMID: 19861528BACKGROUND

  • Ukleja A. Altered GI motility in critically Ill patients: current understanding of pathophysiology, clinical impact, and diagnostic approach. Nutr Clin Pract. 2010 Feb;25(1):16-25. doi: 10.1177/0884533609357568.

    PMID: 20130154BACKGROUND

  • Brown A-M. A Comparison of Two Gastric Feeding Approaches in Mechanically Ventilated Pediatric Patients. Akron, OH: The University of Akron; 2014:159.

    BACKGROUND

Study Officials

  • Ann-Marie Brown, PhD, CPNP

    Akron Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2015

First Posted

October 1, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(6)