Enteral Nutrition Clinical Trial
— ERTENIFABPICUOfficial title:
Stage 1Evaluation of Status of Early Reached Target Enteral Nutrition in Critically Ill Children in the PICU (ERTEN in PICU) Stage 2 IFABP as Biomarker of Feeding Intolerance in Critically Ill Children in the PICU(IFABP in PICU)
Stage 1 - Evaluation of Status of Early Reached Target Enteral Nutrition in critically ill
children in the PICU (ERTEN in PICU).
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 16 Years |
Eligibility |
Inclusion Criteria: - critically iil children who stayed in PICU at least for 4 days - having informed consent from the parents of patients Exclusion Criteria: - children with primary gastrointestinal problems ( ulcerative colitis ,crohn ,acute gastrointestinal bleeding ) |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Bonn University Faculty of Medicine | Bonn |
Lead Sponsor | Collaborator |
---|---|
Gazi University | Acibadem University, Akdeniz University, Ankara University, Children`s Medical Hospital, University of Bonn, Germany, Cukurova University, Dokuz Eylul University, Eskisehir Osmangazi University, Hacettepe University, Istanbul Medipol University Hospital, Istanbul University, Marmara University, Sisli Etfal Training & Research Hospital, TC Erciyes University, Tepecik Training and Research Hospital, Zonguldak Karaelmas University |
Germany,
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.earlhumde — View Citation
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. — View Citation
López-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. Review. — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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. do — View Citation
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 Cri — View Citation
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.0b013e3 — View Citation
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. — View Citation
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.0b013 — View Citation
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. d — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IFABP | IFABP level in urine will be evaluated in critically iil children in order to understand feeding intolerance and /or bacterial translocation | 10 days | Yes |
Secondary | Zonulin | zonulin level in blood will be evaluated in critically ill children in order to show bacterial translocation and intestinal barrier problems | 10 days | Yes |
Secondary | 8-hydroxydeoxyguanosine | 8-hydroxydeoxyguanosine level in urine will be evaluated in critically ill children in order to show bacterial translocation and intestinal barrier problems | 10 days | Yes |
Secondary | Claudin-3 | Claudin-3 level in urine will be evaluated in critically ill children in order to show bacterial translocation and intestinal barrier problems | 10 days | Yes |
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