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: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: f
View:
• Diagnosed with congenital heart disease through symptoms, physical signs, imaging, and ultrasound examinations.
• Age 0-6 months
• Children with nutritional risks (defined by STRONGkids: Nutritional risk screening tool for children )
• Artificial or mixed feeding
• Open heart surgery under cardiopulmonary bypass
• The guardians of the children voluntarily participate in this study and sign a written informed consent form before the surgery.
Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Xu Yulu
xuyulu05@163.com
8602164931532
Backup
Gu Ying
guying0128@ailyun.com
8602164931223
Time Frame
Start Date: 2025-10-13
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 160
Treatments
Experimental: 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. Weight measurements and neurological assessments will be conducted at admission, prior to discharge, and at 1-, 3-, and 6-month intervals post-discharge. The safety of the intervention will be closely monitored throughout the study period.
Active_comparator: General energy density enteral nutrition
General energy density enteral nutrition (60-88cal/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. Weight measurements and neurological assessments will be conducted at admission, prior to discharge, and at 1-, 3-, and 6-month intervals post-discharge. The safety of the intervention will be closely monitored throughout the study period.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Fudan University