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

December 27, 2016 updated by: Elif Keleş,MD, Gazi University

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.

Study Overview

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

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bonn, Germany, 53127
        • Recruiting
        • Bonn University Faculty of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dincer Yıldızdas, 1
        • Principal Investigator:
          • Elif Keles, 1
        • Principal Investigator:
          • Soyhan Bagci, 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The critically ill children in PICU who stay at least for 4 days

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IFABP
Time Frame: 10 days
IFABP level in urine will be evaluated in critically iil children in order to understand feeding intolerance and /or bacterial translocation
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zonulin
Time Frame: 10 days
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
Time Frame: 10 days
8-hydroxydeoxyguanosine level in urine will be evaluated in critically ill children in order to show bacterial translocation and intestinal barrier problems
10 days
Claudin-3
Time Frame: 10 days
Claudin-3 level in urine will be evaluated in critically ill children in order to show bacterial translocation and intestinal barrier problems
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

December 27, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • ERTEN-IFABP IN PICU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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