Evaluation of Status of Early Reached Target Enteral Nutrition and IFABP as Biomarker of Feeding Intolerance in Critically Ill Children

Enteral Nutrition Clinical Trial

— ERTENIFABPICU  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02598375
• Other study ID #: ERTEN-IFABP IN PICU
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2015
• Last updated: December 27, 2016
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Gazi University
• Contact: Elif Keles, 1
• Phone: 00905366741270
• Email: elifkeles.dr[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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

• 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

Recruitment information / eligibility

• 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 )

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Enteral Nutrition
• Feeding Intolerance
• Intestinal Fatty Acid Binding Protein

Intervention

Other:
• 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

Locations

Country	Name	City	State
Germany	Bonn University Faculty of Medicine	Bonn

Sponsors (16)

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

Country where clinical trial is conducted

Germany, 

References & Publications (12)

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

Outcome

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