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

Key facts

Where
Shanghai, ChinaSee the site

Where in China

  • Children's Hospital Of Fudan UniversityShanghai, ChinaContact: Xu YuluTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Children's Hospital of Fudan University
Trial code
NCT07115108
Record updated
13 May 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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); 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; 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; Estimated stay time in the postoperative intensive care unit ≤ 2 days.

ClinicalTrials.gov NCT07115108