NCT04609358

Efficacy and Safety of the Algorithm for Enteral Nutrition Support

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 1 Day – 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Nutrition Disorder, Child

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-07-31
• Completion: 2019-12-31
• First posted: 2020-10-30
• Last updated: 2020-10-30

Locations

1 site across 1 country: China