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Evaluation of Enteral Nutrition in Critically Ill Children

Sponsor
Cukurova University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04013893
Collaborator
(none)
20
Enrollment
1
Location
12
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements. Early enteral nutrition will be initiated within the first 24 hours of hospitalization in critically ill children who have inotropic vasopressor and inodilator support without any problems and contraindications in gastrointestinal system functions. The energy requirement of the intubated patients will be measured by indirect calorie meter method. Schofield method will be used to calculate the daily energy needs of extubated patients. 30% of the targeted energy in the first 48 hours of hospitalization and 80% of the targeted energy in the first week will be achieved by enteral nutrition.Nutritional solutions with a concentrated formula of 1 / 1.5 will be given to patients with cardiac pulmonary or renal disease requiring fluid restriction.Patients will be followed up for vomiting, diarrhea, abdominal distention, feeding intolerance, gastric residues and gastrointestinal bleeding. If these findings develop, the patient's nutrition will be interrupted according to the clinician's assessment and enteral nutrition will be re-fed as soon as possible.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Enteral Nutrition in Critically Ill Children Receiving Inotropic Support in Pediatric Intensive Care Unit
    Actual Study Start Date :
    Jun 1, 2019
    Anticipated Primary Completion Date :
    Jan 1, 2020
    Anticipated Study Completion Date :
    Jun 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 28-d mortality [28 days]

      To evaluate the effect of enteral feeding timing on survival

    Secondary Outcome Measures

    1. Lactate [During inotropic treatment]

      To observe safe lactate levels suitable for enteral nutrition. Lactate levels will be measure 4 times in a day.

    2. Vasoactive inotrope score [During inotropic treatment]

      To observe maximum vasoactive inotrope score suitable for enteral nutrition. Maximum VIS will be recorded.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children with normal gastrointestinal system function

    • Children receiving inotropic, vasopressor or inodilatory support

    Exclusion Criteria:

    • Children with gastrointestinal system dysfunction

    • Children with enteral nutrition contraindicated

    • Children with metabolic disease with special nutrition

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cukurova University, Division of Pediatric Intensive Care Unit Adana Turkey 01380

    Sponsors and Collaborators

    • Cukurova University

    Investigators

    • Study Chair: Dincer Yildizdaş, Professor, Cukurova University Medicine Faculty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmet Yontem, Principal Investigator, Cukurova University
    ClinicalTrials.gov Identifier:
    NCT04013893
    Other Study ID Numbers:
    • CUTF-GOKAEK-86
    First Posted:
    Jul 10, 2019
    Last Update Posted:
    Jul 12, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmet Yontem, Principal Investigator, Cukurova University
    Enteral feeding
    vasopressor
    lactate
    Additional relevant MeSH terms:
    Critical Illness

    Study Results

    No Results Posted as of Jul 12, 2019