Evaluation of Enteral Nutrition in Critically Ill Children

• Conditions: Critical Illness; Enteral Feeding Intolerance

• Registration Number: NCT04013893
• Lead Sponsor: Cukurova University

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.

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 Timeline

• Study Start: 2019-06-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-12
• Primary Completion: 2020-01-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-d mortality	28 days	To evaluate the effect of enteral feeding timing on survival

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cukurova University, Division of Pediatric Intensive Care Unit; 🇹🇷 Adana, Turkey