Recruiting NCT07115108
Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High energy density enteral nutrition, General energy density enteral nutrition.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease, Enteral Nutrition, Pediatrics. Basic parameters: 0 months — 6 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Dietary supplement 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. - Dietary supplement 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.
Primary outcome measures
- Weight-for-age z score (WAZ) [Time frame: 6th month after discharge]
Secondary outcome measures (11)
- Weight-for-age z score (WAZ) [Time frame: Before discharge, 1st month, 3rd month after discharge]
- Cognitive development [Time frame: Before discharge, 1st month, 3rd month, 6th month after discharge]
- Incidence of subjects with Gastrointestinal mucosal barrier function injury [Time frame: Before discharge, 1 month, 3 months, 6 months after discharge]
- Albumin level [Time frame: Before discharge, 1 month, 3 months, 6 months after discharge]
- Blood lipid levels [Time frame: Before discharge, 1 month, 3 months, 6 months after discharge]
- Energy intake (cal/d) [Time frame: During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge]
- Enteral Nutrition intake (ml/d) [Time frame: During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge]
- Incidence of malabsorption [Time frame: During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge]
- Incidence of feeding intolerance [Time frame: During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge]
- Incidence of necrotizing enterocolitis（NEC） [Time frame: Before discharge, 1 month, 3 months, 6 months after discharge]
- Other surgical indications [Time frame: At the day of discharge, an average of 3 week after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Children's Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT07115108 · FNF202531 · 2024YFC707605