Actively Recruiting
Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease
Led by Children's Hospital of Fudan University · Updated on 2026-05-13
160
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 to 6 months
- Nutritional risks as defined by STRONGkids nutritional risk screening tool for children
- Receiving artificial or mixed feeding
- Underwent open heart surgery with cardiopulmonary bypass
- Guardians voluntarily agree to 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 before surgery, growth-restricting genetic diseases, or chromosomal syndromes (trisomy 21, trisomy 18)
- Abnormal immune system function from congenital or acquired causes, impairing ability to fight infections or abnormal cells
- History of neurological diseases before surgery (e.g., encephalitis, epilepsy)
- Symptoms of gastrointestinal infection like abdominal distension or diarrhea after surgery
- 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
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
CONTACT
G
Gu Ying
CONTACT
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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