Clinical trial NCT02598375: Evaluation of Status of Early Reached Target Enteral Nutrition and IFABP as Biomarker of Feeding Intolerance in Critically Ill Children
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Enteral Nutrition
Feeding Intolerance
Intestinal Fatty Acid Binding Protein
Keywords: Early reached target enteral nutrition in PICU feeding intolerance IFABP
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Cukurova University
name: Children's Medical Hospital, University of Bonn, Germany
name: Eskisehir Osmangazi University
name: Akdeniz University
name: TC Erciyes University
name: Hacettepe University
name: Dokuz Eylul University
name: Tepecik Training and Research Hospital
name: Marmara University
name: Ankara University
name: Zonguldak Bulent Ecevit University
name: Istanbul University
name: Istanbul Medipol University Hospital
name: Sisli Hamidiye Etfal Training and Research Hospital
name: Acibadem University
First posted: 2015-11-05
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The critically ill children in PICU who stay at least for 4 days

Brief 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.

Detailed 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

Eligibility criteria: 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 )

Primary outcomes:
measure: IFABP
timeFrame: 10 days
Secondary outcomes:
measure: Zonulin
timeFrame: 10 days
measure: 8-hydroxydeoxyguanosine
timeFrame: 10 days
measure: Claudin-3
timeFrame: 10 days
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Bonn University Faculty of Medicine
Study officials:
affiliation: Çukurova University Faculty of Medicine
name: Dincer Yildizdas, 3
role: STUDY_CHAIR
affiliation: Bonn University Faculty of Medicine
name: Soyhan Bagcı, 2
role: STUDY_DIRECTOR
References:
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