Efficacy and Safety of the Algorithm for Enteral Nutrition Support

Nutrition Disorder, Child Clinical Trial

Official title:

Efficacy and Safety of the Implementation of an Algorithm for Enteral Nutrition Support Compared With Traditional Practice in Children With Congenital Heart Disease: Randomized Clinical Trial, Simple Blind.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609358
• Other study ID #: SCMCIRB-K2015003
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to evaluate the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease

Description:

In many developing countries, pediatric cardiac programs are not fully established, and nutrition support algorithm is lack. Therefore, this study aimed to evaluate the the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease. The usual standard practice for feeding often interrupted by retention in the gut and then choose the parenteral nutrition support especially in the patients with unstable hemodynamic status. Actually tiny and continuous feeding would improve the gut function and reach the adequate energy supply.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: December 31, 2019
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

weight-for-age of z-score <-2; or length-for-age of z score <-2; or weight-for-length of z score <-2 Exclusion Criteria: Any patient with congenital genetic metabolic diseases

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Nutrition Disorder, Child
• Nutrition Disorders

Intervention

Other:
• intervention group
When patients' hemodynamics was stable, start 1-2ml/kg/hr post-op 6-12 hours and increased 1-2ml/kg/hr each day if tolerating to reach the target energy supply When patients' hemodynamics wasn't stable, start post-op 6-12 hours 0.5-1ml/kg/hr and increased 0.5-1ml/kg/hr each day if tolerating to reach the target energy supply.

Locations

Country	Name	City	State
China	Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malnutrition recovery	Malnutrition was assessed as recovering from malnutrition	1 year
Secondary	Feeding intolerance	According to the criteria established by the American Academy of Pediatrics in 2003, the following symptoms are diagnosed as feeding intolerance: severe abdominal distension or discoloration; Signs of intestinal perforation; Obvious blood stool; Gastric retention = 25% of the total amount after 2 to 3 feeding intervals; Bile reflux or vomiting; Severe apnea or bradycardia; Severe cardiopulmonary insufficiency; Apnea: Cessation of breathing for =20 seconds, or cessation of breathing accompanied by a decrease in SpO2.	1 year