Evaluation of Enteral Nutrition in Critically Ill Children

July 10, 2019 updated by: Ahmet Yontem, Cukurova University

Evaluation of Enteral Nutrition in Critically Ill Children Receiving Inotropic Support in Pediatric Intensive Care Unit

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

20

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 Locations

  • Turkey
      • Adana, Turkey, 01380
        • Recruiting
        • Cukurova University, Division of Pediatric Intensive Care Unit
        • Contact:

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 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically ill children who have inotropic, vasopressor or inodilatory supplements without any problems and contraindications in gastrointestinal system functions

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-d mortality
Time Frame: 28 days
To evaluate the effect of enteral feeding timing on survival
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lactate
Time Frame: During inotropic treatment
To observe safe lactate levels suitable for enteral nutrition. Lactate levels will be measure 4 times in a day.
During inotropic treatment
Vasoactive inotrope score
Time Frame: During inotropic treatment
To observe maximum vasoactive inotrope score suitable for enteral nutrition. Maximum VIS will be recorded.
During inotropic treatment

Collaborators and Investigators

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

Sponsor

Cukurova University

Investigators

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

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 (Actual)

June 1, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 10, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUTF-GOKAEK-86

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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