Evaluation of Enteral Nutrition in Critically Ill Children

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04013893
• Other study ID #: CUTF-GOKAEK-86
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2019
• Source: Cukurova University
• Contact: Ahmet Yöntem
• Phone: +905075097709
• Email: drayontem[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Enteral Feeding Intolerance

Locations

Country	Name	City	State
Turkey	Cukurova University, Division of Pediatric Intensive Care Unit	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-d mortality	To evaluate the effect of enteral feeding timing on survival	28 days
Secondary	Lactate	To observe safe lactate levels suitable for enteral nutrition. Lactate levels will be measure 4 times in a day.	During inotropic treatment
Secondary	Vasoactive inotrope score	To observe maximum vasoactive inotrope score suitable for enteral nutrition. Maximum VIS will be recorded.	During inotropic treatment