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| Name | Class |
|---|---|
| Cukurova University | OTHER |
| Children's Medical Hospital, University of Bonn, Germany | OTHER |
| Eskisehir Osmangazi University | OTHER |
| Akdeniz University |
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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
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
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.
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.We aim to reach these goals in our study
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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feeding intolerance | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| IFABP | IFABP level in urine will be evaluated in critically iil children in order to understand feeding intolerance and /or bacterial translocation | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Zonulin | zonulin level in blood will be evaluated in critically ill children in order to show bacterial translocation and intestinal barrier problems | 10 days |
| 8-hydroxydeoxyguanosine | 8-hydroxydeoxyguanosine level in urine will be evaluated in critically ill children in order to show bacterial translocation and intestinal barrier problems |
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Inclusion Criteria:
Exclusion Criteria:
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The critically ill children in PICU who stay at least for 4 days
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elif Keles, 1 | Contact | 00905366741270 | elifkeles.dr@gmail.com | |
| Soyhan Bagci, 2 | Contact | 004915158233102 | soyhan.bagci@ukb.uni-bonn.de |
| Name | Affiliation | Role |
|---|---|---|
| Dincer Yildizdas, 3 | Çukurova University Faculty of Medicine | Study Chair |
| Soyhan Bagcı, 2 | Bonn University Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bonn University Faculty of Medicine | Recruiting | Bonn | 53127 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19903872 | Result | 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. | |
| 19202390 | Result | 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. |
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It is concluded the first phase of ERTEN-IFABP IN PICU.95 patients date were evaluated and the statistically significant results were obtained in the first observational phase of the study We conduct the second phase of our study.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 21, 2021 | |
| Reset | Jul 12, 2021 |
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| 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 |
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Urine and blood will be collected from critically ill children in PICU
| 10 days |
| 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 |
| 21868501 | Result | 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. |
| 22564954 | Result | 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. |
| 19398612 | Result | 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. |
| 8788267 | Result | 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. |
| 24403379 | Result | 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. |
| 21641735 | Result | 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. |
| 22974599 | Result | 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. |
| 21245670 | Result | 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. |
| 20381302 | Result | 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. |
| 23782971 | Result | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 21, 2021 | Jul 12, 2021 |