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| ID | Type | Description | Link |
|---|---|---|---|
| 2024YFC707605 | Other Grant/Funding Number | National Health Commission of the People's Republic of China |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High energy density enteral nutrition | Experimental | 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. Weight measurements and neurological assessments will be conducted at admission, prior to discharge, and at 1-, 3-, and 6-month intervals post-discharge. The safety of the intervention will be closely monitored throughout the study period. |
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| General energy density enteral nutrition | Active Comparator | General energy density enteral nutrition (60-88cal/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. Weight measurements and neurological assessments will be conducted at admission, prior to discharge, and at 1-, 3-, and 6-month intervals post-discharge. The safety of the intervention will be closely monitored throughout the study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High energy density enteral nutrition | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight-for-age z score (WAZ) | 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. | 6th month after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Weight-for-age z score (WAZ) | 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. | Before discharge, 1st month, 3rd month after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Yulu | Contact | 8602164931532 | xuyulu05@163.com | |
| Gu Ying | Contact | 8602164931223 | guying0128@ailyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 201102 | China |
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| General energy density enteral nutrition | Dietary Supplement | 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. |
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| Cognitive development | 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). | Before discharge, 1st month, 3rd month, 6th month after discharge |
| Incidence of subjects with Gastrointestinal mucosal barrier function injury | 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. | Before discharge, 1 month, 3 months, 6 months after discharge |
| Albumin level | 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. | Before discharge, 1 month, 3 months, 6 months after discharge |
| Blood lipid levels | 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. | Before discharge, 1 month, 3 months, 6 months after discharge |
| Energy intake (cal/d) | Calculate the caloric intake for enteral feeding according to the Schofeld formula recommended by the European Society for Pediatric and Neonatal Intensive Care (ESPNIC) | During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge |
| Enteral Nutrition intake (ml/d) | 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. | During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge |
| Incidence of malabsorption | 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. | During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge |
| Incidence of feeding intolerance | 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) | During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge |
| Incidence of necrotizing enterocolitis（NEC） | NEC diagnosed in stage II and III will be recorded. | Before discharge, 1 month, 3 months, 6 months after discharge |
| Other surgical indications | 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. | At the day of discharge, an average of 3 week after surgery |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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