Actively Recruiting
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
Led by Children's Hospital of Fudan University · Updated on 2026-05-13
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how high-energy-density enteral nutrition compares to ordinary energy density nutrition in improving physical growth and brain cognitive development in infants with congenital heart disease after surgery. This study also aims to assess the safety of these nutritional interventions in this vulnerable population. Infants who have undergone open heart surgery for congenital heart disease will receive either high-energy-density enteral nutrition (100 cal/100 ml) or general energy density enteral nutrition (60-88 cal/100 ml). The feeding volume will be based on the infant's body weight (80-100 ml/kg), with adjustments made to feeding volume and frequency as needed. Weight and neurological development will be assessed at admission, before discharge, and at 1, 3, and 6 months after discharge, with safety monitored throughout. Participants will undergo regular evaluations including weight measurements and cognitive assessments at specified time points before discharge and up to six months after. Researchers will monitor nutritional intake, gastrointestinal function, blood markers like albumin and blood lipids, and any feeding-related complications. The primary outcome is the weight-for-age z score at six months after discharge, with several secondary outcomes assessed throughout the study period. The total participation duration spans from hospital admission through six months post-discharge.
CONDITIONS
Brief Title
Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with congenital heart disease through symptoms, physical signs, imaging, and ultrasound examinations
- Age 0-6 months
- Children with nutritional risks as defined by STRONGkids nutritional risk screening tool
- Artificial or mixed feeding
- Open heart surgery under cardiopulmonary bypass
- Guardians voluntarily participate and sign informed consent before surgery
You will not qualify if you...
- Diagnosed with major non-cardiac diseases causing nutritional intake disorders, such as congenital gastrointestinal malformations, gastroesophageal reflux, genetic diseases related to growth restriction, or chromosomal abnormalities like trisomy 21 or trisomy 18
- Abnormal immune system function due to congenital or acquired causes
- Any preoperative history of neurological diseases such as encephalitis or epilepsy
- Secondary or primary gastrointestinal infection symptoms after surgery like abdominal distension and diarrhea
- Estimated postoperative intensive care unit stay of 2 days or less
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks
Participants undergo open heart surgery for congenital heart disease and begin post-operative care.
Visits at admission and day of discharge
Duration - From post-surgery until discharge
Participants receive either high-energy-density or general energy-density enteral nutrition following surgery with feeding volume and frequency adjusted based on body weight.
Daily feeding during hospitalization
Duration - 6 months post-discharge
Participants have weight measurements and neurological assessments to monitor physical growth and cognitive development after discharge.
Visits at 1 month, 3 months, and 6 months post-discharge
Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
Research Team
X
Xu Yulu
G
Gu Ying
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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