Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease
Recruiting now · Not applicable
Conditions studied: Congenital Heart Disease, Enteral Nutrition, Pediatrics
In brief
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 facts
- Study ID
- NCT07115108
- Run by
- Children's Hospital of Fudan University
- People needed
- 160
- Starts
- 2025-10-13
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-05-13
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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