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
Children's Hospital of Fudan University
160 participants
Oct 13, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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.
Exclusion Criteria5
- Diagnosed with major non cardiac diseases leading to nutritional intake disorders, such as congenital gastrointestinal malformations, preoperative diagnosis of gastroesophageal reflux, genetic diseases related to growth restriction, and various syndromes with chromosomal abnormalities (trisomy 21 syndrome, trisomy 18 syndrome)
- Abnormal immune system function due to congenital or acquired factors, unable to effectively resist pathogens or eliminate abnormal cells, which can be divided into primary and secondary immunodeficiencies.
- Any pre - operative history of neurological diseases (e.g., encephalitis, epilepsy).
- Secondary or primary gastrointestinal infection symptoms such as abdominal distension and diarrhea after surgery.
- Estimated stay time in the postoperative intensive care unit ≤ 2 days
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Interventions
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 (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.
Locations(1)
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NCT07115108