Congenital Heart Disease, Enteral Nutrition, Pediatrics
Conditions
Keywords
Congenital heart disease, Enteral nutrition, Pediatrics
Brief 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.
Interventions
DIETARY_SUPPLEMENTHigh 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_SUPPLEMENTGeneral 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.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Months to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight-for-age z score (WAZ) | Before discharge, 1st month, 3rd 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. |
| Cognitive development | Before discharge, 1st month, 3rd month, 6th month after discharge | The Griffiths mental development scales (GMDs) will be used to repeatedly measure the indicators .The Griffiths scales typically yield a Developmental Quotient (DQ) with an average range of 85-115. The higher the scores, the more advanced development relative to age norms in assessed domains (e.g., motor, language, or cognition). |
| Incidence of subjects with Gastrointestinal mucosal barrier function injury | Before discharge, 1 month, 3 months, 6 months after discharge | Primarily defined by elevation in fecal calprotectin and Inflammatory cytokines level.The reference range for calprotectin is 0-5 μg/g，inflammatory cytokines is ≤20pg/ml.Exceeding this range will be considered as abnormal gastrointestinal mucosal barrier function. |
| Albumin level | Before discharge, 1 month, 3 months, 6 months after discharge | Albumin is a rich protein in the blood, which mainly reflects the nutritional status.The reference range for albumin is 39-54g/L.If it is not within this range, it will be judged as abnormal. |
| Blood lipid levels | Before discharge, 1 month, 3 months, 6 months after discharge | Blood lipid test is to measure the content of lipids in blood.Blood lipids include total cholesterol(0-5.18mmol/L) and triglycerides(0-1.7mmol/L).If it exceeds the range, it will be considered as abnormal. |
| Energy intake (cal/d) | During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge | Calculate the caloric intake for enteral feeding according to the Schofeld formula recommended by the European Society for Pediatric and Neonatal Intensive Care (ESPNIC) |
| Enteral Nutrition intake (ml/d) | During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge | Based on the child's weight and the fluid balance in the previous 24 hours, the total fluid intake for the day is calculated. After subtracting the amount of intravenous drug solution, the amount of enteral nutrition formula is obtained. According to the child's gastrointestinal function, the principle of gradual progress is adopted to rationally allocate the single feeding volume and feeding frequency. |
| Incidence of malabsorption | During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge | Incidence of malabsorption (as defined by any of the following criteria): abnormal fecal lactose content; abnormal fecal fat content.The diagnosis will be confirmed by fecal examination. |
| Incidence of feeding intolerance | During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge | Any of the following condition: 1. Frequent vomiting (≥ 3 times/d); 2.Abdominal distension; 3. Milk volume did not increase or decreased\>3 d; 4. Gastric retention (retention\>1/3 of the previous feeding); 5. Unplanned discontinuation of feeding ≥ 2 times; 6. Diarrhea (stool frequency\>6 times/d) |
| Incidence of necrotizing enterocolitis（NEC） | Before discharge, 1 month, 3 months, 6 months after discharge | NEC diagnosed in stage II and III will be recorded. |
| Other surgical indications | At the day of discharge, an average of 3 week after surgery | Mechanical ventilation time (days), postoperative CCU hospitalization duration (days), total hospitalization duration (days), hospitalization costs (Yuan), and the incidence of poor wound healing will be recorded. |
Countries
China
Contacts
CONTACTXu Yulu
CONTACTGu Ying
Outcome results
None listed