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Infants with congenital heart disease (CHD) are usually born with a normal weight but develop malnutrition over time, and about 20-50% of these children are usually malnourished. Malnutrition in these patients is multifactorial. To compensate for the increased need for infants and children with CHD, an increase in their caloric intake has been suggested. However, these patients may not be able to receive enough to meet the increased needs and catch-up growth. One of the suggested solutions in these patients to compensate for inadequate food intake is to increase the caloric density of milk or formula. For this purpose, the use of special formulas with higher calorie density or enrichment of normal formula or breast milk using special enrichment formula could be suggested. In the present study, the effect of increasing calorie intake by increasing the concentration of normal formula in comparison with formula with standard concentration on weight gain and other anthropometric indices of CHD patients with malnutrition will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard formula | Placebo Comparator | Feeding the infant or child with the regular formula which is prepared with standard concentrations |
|
| Nutrient-dense formula | Active Comparator | Feeding the infant or child with the nutrient-dense formula which is prepared by concentrating regular formula. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant formula | Dietary Supplement | Regular infant formula will be concentrated to give a calorie density of about 90 kcal/100 mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Body weight of infant or child | Change from baseline at 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Length | Recumbent length of infant or child | Change from baseline at 2 months |
| Mid-arm circumference | mid upper-arm circumference of infant or child |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajaei Cardiovascular, Medical & Research Center | Tehran | Iran |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Change from baseline at 2 months |
| Head circumference | Head circumference | Change from baseline at 2 months |
| IGF1 | Serum IGF1 | Change from baseline at 2 months |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |