Evaluation of Status of Early Reached Target Enteral Nutrition and IFABP as Biomarker of Feeding Intolerance in Critically Ill Children
NCT ID: NCT02598375
Last Updated: 2016-12-28
Study Results
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Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2015-01-31
2017-12-31
Brief Summary
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In critically ill children, there is no data on the factors influenced the enteral nutrition and feeding intolerance.The investigators aim to reach these goals in our study
* To initiate the enteral feeding in pediatric intensive care units or not
* To demonstrate the reasons whether early enteral feeding is initiated or not
* To determine the incidence of feeding intolerance
* To identify the situations such as analgesia ,sedation, catecholamines or individual preferences of the medical staff which lead to delay or interruption in enteral feeding in pediatric intensive care units
* To investigate the relation between the successful enteral feeding and mortality , morbidity du to the sepsis , septic shock and multiorgan failure
Stage 2 - IFABP as biomarker of feeding intolerance in critically ill children in the PICU (IFABP in PICU)
Critically ill children are at increased risk for intestinal injury, gastrointestinal dysfunction and feeding intolerance, which are associated with delayed recovery and increased morbidity and mortality during their course in the pediatric intensive care unit. In critically ill children, there is little data on the factors influenced the enteral nutrition. We hypothesise that IFABP might be used as a biomarker which shows that the early intestinal damage due to these medications.
Aim There is no information which shows that the role of the intestinal microcirculation problems and mucosal integrity on feeding intolerance in pediatric intensive care unit.We aim to reach these goals in our study
* To show the value of IFABP regarding the identifying feeding intolerance and early detection of enteral feeding intolerance
* To show the relation between the IFABP concentration and enteral feeding intolerance
* To show the relation between the mechanical ventilation settings , sedation , inotropic medications doses and IFABP concentration and feeding intolerance
* To show the relation between IFABP concentrations and mortality and morbidity due to the sepsis , septic shock and multi system organ failure
Stage 1 (ERTEN in PICU) was completed . In many patients, initiation of feeding seems to be delayed without an evidence-based reason. ERTEN was achieved in 43 (25.3%) of 95 patients within 48 h after PICU admission. Patients with Early Initiation of Feeding were statistically significant more likely to have ERTEN. ERTEN was independent significant prognostic factors for survival (p\<0.001), with reached target enteral caloric intake on day 2 indicating improved survival.
Detailed Description
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* To initiate the enteral feeding in pediatric intensive care units or not
* To demonstrate the reasons whether early enteral feeding is initiated or not
* To determine the incidence of feeding intolerance
* To identify the situations such as analgesia ,sedation, catecholamines or individual preferences of the medical staff which lead to delay or interruption in enteral feeding in pediatric intensive care units
* To investigate the relation between the successful enteral feeding and mortality , morbidity du to the sepsis , septic shock and multiorgan failure
Stage 2 - IFABP as biomarker of feeding intolerance in critically ill children in the PICU (IFABP in PICU) Critically ill children are at increased risk for intestinal injury, gastrointestinal dysfunction and feeding intolerance, which are associated with delayed recovery and increased morbidity and mortality during their course in the pediatric intensive care unit. In critically ill children, there is little data on the factors influenced the enteral nutrition. Feeding intolerance in the critically ill children may be due to in part to alterations in gastrointestinal motility secondary to the underlying disease process or administrations of medication.It is also known the role of hyperglycemia, caloric density of enteral nutrition and gastrointestinal feedback mechanism, and routine intensive care management such as sedation, analgesia and catecholamines on the feeding intolerance in critically ill children. We hypothesise that IFABP might be used as a biomarker which shows that the early intestinal damage due to these medications.
Aim There is no information which shows that the role of the intestinal microcirculation problems and mucosal integrity on feeding intolerance in pediatric intensive care unit.We aim to reach these goals in our study
* To show the value of IFABP regarding the identifying feeding intolerance and early detection of enteral feeding intolerance
* To show the relation between the IFABP concentration and enteral feeding intolerance
* To show the relation between the mechanical ventilation settings , sedation , inotrope medications doses and IFABP concentration and feeding intolerance
* To show the relation between IFABP concentrations and mortality and morbidity due to the sepsis , septic shock and multi system organ failure We aim to reach theses goals in near future
* To find the common definitions regarding enteral feeding intolerance in order to identify and recognize the clinical problems in advance for the medical staff in Turkey
* To recognize the patients who have the possibility the enteral feeding problems with the help of the clinical and biochemical biomarkers (IFABP)
* To establish the early enteral feeding protocols in order to provide widespread using in pediatric intensive care units.
* With the help of these acquirement in the pediatrics intensive care unit to achieve the reduce the length of hospital stay , morbidity and mortality
The critically ill children who are hospitalized at least for 24 hours in PICU are eligible for the Stage 1ERTEN IN PICU
The critically ill children who are hospitalized at least for 4 days in PICU are eligible for the Stage2 IFABP IN PICU
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Children with feeding intolerance
Critically ill children having with respiratory or catecholamine support in PICU have the feeding intolerance at least for12 hours or more.
Feeding intolerance
In this study ; it is aimed to show the value of IFABP regarding the identifying the feeding intolerance and early detection of enteral feeding intolerance
Children without feeding intolerance
Critically ill children having with respiratory or catecholamine support in PICU have not the feeding intolerance signs at least for 12 hours or less
Feeding intolerance
In this study ; it is aimed to show the value of IFABP regarding the identifying the feeding intolerance and early detection of enteral feeding intolerance
Interventions
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Feeding intolerance
In this study ; it is aimed to show the value of IFABP regarding the identifying the feeding intolerance and early detection of enteral feeding intolerance
Eligibility Criteria
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Inclusion Criteria
* having informed consent from the parents of patients
Exclusion Criteria
1 Month
16 Years
ALL
No
Sponsors
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Cukurova University
OTHER
Children's Medical Hospital, University of Bonn, Germany
OTHER
Eskisehir Osmangazi University
OTHER
Akdeniz University
OTHER
TC Erciyes University
OTHER
Hacettepe University
OTHER
Dokuz Eylul University
OTHER
Tepecik Training and Research Hospital
OTHER
Marmara University
OTHER
Ankara University
OTHER
Zonguldak Bulent Ecevit University
OTHER
Istanbul University
OTHER
Istanbul Medipol University Hospital
OTHER
Sisli Hamidiye Etfal Training and Research Hospital
OTHER
Acibadem University
OTHER
Gazi University
OTHER
Responsible Party
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Elif Keleş,MD
MD ,Resident Physician in Pediatrics
Principal Investigators
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Dincer Yildizdas, 3
Role: STUDY_CHAIR
Çukurova University Faculty of Medicine
Soyhan Bagcı, 2
Role: STUDY_DIRECTOR
Bonn University Faculty of Medicine
Locations
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Bonn University Faculty of Medicine
Bonn, , Germany
Countries
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Central Contacts
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Facility Contacts
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Soyhan Bagci, 1
Role: primary
Elif Keleş, 2
Role: backup
References
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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.
Lopez-Herce J. Gastrointestinal complications in critically ill patients: what differs between adults and children? Curr Opin Clin Nutr Metab Care. 2009 Mar;12(2):180-5. doi: 10.1097/MCO.0b013e3283218285.
Pathan N, Burmester M, Adamovic T, Berk M, Ng KW, Betts H, Macrae D, Waddell S, Paul-Clark M, Nuamah R, Mein C, Levin M, Montana G, Mitchell JA. Intestinal injury and endotoxemia in children undergoing surgery for congenital heart disease. Am J Respir Crit Care Med. 2011 Dec 1;184(11):1261-9. doi: 10.1164/rccm.201104-0715OC. Epub 2011 Aug 25.
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.
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.
Chellis MJ, Sanders SV, Webster H, Dean JM, Jackson D. Early enteral feeding in the pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 1996 Jan-Feb;20(1):71-3. doi: 10.1177/014860719602000171.
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.
Aydemir C, Dilli D, Oguz SS, Ulu HO, Uras N, Erdeve O, Dilmen U. Serum intestinal fatty acid binding protein level for early diagnosis and prediction of severity of necrotizing enterocolitis. Early Hum Dev. 2011 Oct;87(10):659-61. doi: 10.1016/j.earlhumdev.2011.05.004. Epub 2011 Jun 8.
Reisinger KW, Van der Zee DC, Brouwers HA, Kramer BW, van Heurn LW, Buurman WA, Derikx JP. Noninvasive measurement of fecal calprotectin and serum amyloid A combined with intestinal fatty acid-binding protein in necrotizing enterocolitis. J Pediatr Surg. 2012 Sep;47(9):1640-5. doi: 10.1016/j.jpedsurg.2012.02.027.
Thuijls G, van Wijck K, Grootjans J, Derikx JP, van Bijnen AA, Heineman E, Dejong CH, Buurman WA, Poeze M. Early diagnosis of intestinal ischemia using urinary and plasma fatty acid binding proteins. Ann Surg. 2011 Feb;253(2):303-8. doi: 10.1097/SLA.0b013e318207a767.
van Haren FM, Pickkers P, Foudraine N, Heemskerk S, Sleigh J, van der Hoeven JG. The effects of methylene blue infusion on gastric tonometry and intestinal fatty acid binding protein levels in septic shock patients. J Crit Care. 2010 Jun;25(2):358.e1-7. doi: 10.1016/j.jcrc.2010.02.008. Epub 2010 Apr 8.
Piton G, Belon F, Cypriani B, Regnard J, Puyraveau M, Manzon C, Navellou JC, Capellier G. Enterocyte damage in critically ill patients is associated with shock condition and 28-day mortality. Crit Care Med. 2013 Sep;41(9):2169-76. doi: 10.1097/CCM.0b013e31828c26b5.
Other Identifiers
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ERTEN-IFABP IN PICU
Identifier Type: -
Identifier Source: org_study_id