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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-6
SponsorChildren's Hospital of Fudan University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • High energy density enteral nutrition
  • General energy density enteral nutrition

Treatment groups

160 Participants
are divided into 2 treatment groups