Efficacy and Safety of the Algorithm for Enteral Nutrition Support

Not Applicable

Completed

• Conditions: Nutrition Disorder, Child
• Interventions: Other: intervention group

• Registration Number: NCT04609358
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-04-04
• Primary Completion: 2018-07-31
• Study Completion: 2019-12-31
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-25
• Last Update Submitted: 2020-10-25
• Study First Posted: 2020-10-30
• Last Update Posted: 2020-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention group	intervention group	The patients' nutrition were supported according the the algorithm of the enteral nutrition.

Primary Outcome Measures

Name	Time	Method
Malnutrition recovery	1 year	Malnutrition was assessed as recovering from malnutrition

Secondary Outcome Measures

Name	Time	Method
Feeding intolerance	1 year	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.

Trial Locations

Locations (1)

Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China