NCT07115108

Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease

Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease: A Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 0 Months – 6 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effect of high and ordinary energy density enteral nutrition for improving physical growth and brain cognitive development in infants with congenital heart disease after operation, as well as evaluate the safety of interventions.

Conditions

• Congenital Heart Disease
• Enteral Nutrition
• Pediatrics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High energy density enteral nutrition	High-energy-density enteral nutrition (100 cal/100 ml) will be administered to infants following surgery for congenital heart disease. The target feeding volume will be determined based on the infant's body weight (80-100 ml/kg), with the volume per feeding and frequency appropriately adjusted.
DIETARY_SUPPLEMENT	General energy density enteral nutrition	General energy density enteral nutrition (60-88 cal/100 ml) will be administered to infants following surgery for congenital heart disease. The target feeding volume will be determined based on the infant's body weight (80-100 ml/kg), with the volume per feeding and frequency appropriately adjusted.

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-08-11
• Last updated: 2025-08-26

Locations

2 sites across 1 country: China