Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease
High energy density enteral nutritionGeneral energy density enteral nutrition
High energy density enteral nutrition: 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: 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.
Study 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
Sex
ALL
Min age
0 Months
Max age
6 Months
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Weight-for-age z score (WAZ) — 6th month after discharge WAZ is calculated according to the Chinese child growth curve and cut-offs .It is a statistical index used to assess the nutritional status of children. The physical examination will be conducted by a nurse, and the data will be recorded to one decimal place.
Trial sites (1)
Facility
City
Region
Status
Children's Hospital of Fudan University
Shanghai
Shanghai Municipality
Recruiting
More Children's Hospital of Fudan University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.