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

Sponsor
Children's Hospital of Fudan University
Study ID
NCT07115108
Status
Recruiting
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Conditions

  • Congenital Heart Disease
  • Enteral Nutrition
  • Pediatrics

Eligibility Criteria

Sex
ALL
Age
0 Months - 6 Months
Healthy Volunteers
Not accepted

Interventions

  • High energy density enteral nutrition — DIETARY_SUPPLEMENT
    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.
  • General energy density enteral nutrition — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

First listed
Aug 11, 2025
Start date
Oct 13, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Weight-for-age z score (WAZ) [ Time Frame: 6th month after discharge ]

Central Contacts

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