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

NCT02598375 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2016-12-28

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Cukurova University

    collaborator OTHER
  • Children's Medical Hospital, University of Bonn, Germany

    collaborator OTHER
  • Eskisehir Osmangazi University

    collaborator OTHER
  • Akdeniz University

    collaborator OTHER
  • TC Erciyes University

    collaborator OTHER
  • Hacettepe University

    collaborator OTHER
  • Dokuz Eylul University

    collaborator OTHER
  • Tepecik Training and Research Hospital

    collaborator OTHER
  • Marmara University

    collaborator OTHER
  • Ankara University

    collaborator OTHER
  • Zonguldak Bulent Ecevit University

    collaborator OTHER
  • Istanbul University

    collaborator OTHER
  • Istanbul Medipol University Hospital

    collaborator OTHER
  • Sisli Hamidiye Etfal Training and Research Hospital

    collaborator OTHER
  • Acibadem University

    collaborator OTHER
  • Gazi University

    lead OTHER

Principal Investigators

  • Dincer Yildizdas, 3 · Çukurova University Faculty of Medicine

  • Soyhan Bagcı, 2 · Bonn University Faculty of Medicine

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02598375 on ClinicalTrials.gov