Effect of Feeding With Nutrient Dense Formula in Malnourished Infants and Children With Congenital Heart Defects

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Feeding With Nutrient Dense Formula Compared to Standard Formula on Anthropometric Indices, in Malnourished Infants and Children With Congenital Heart Defects After Repair Surgery

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Dietary Supplement: Infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant and children 6 to 24 months with CHD undergoing repair surgery Malnutrition (weight for age Z score ≤ -1) Exclusion Criteria: Allergy to cow's milk protein Preterm infant or infant weighing less than 2500 grams at birth Children with chromosomal disease (Down, Turner)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard formula<br>Feeding the infant or child with the regular formula which is prepared with standard concentrations | Dietary Supplement: Infant formula<br>* Regular infant formula will be concentrated to give a calorie density of about 90 kcal/100 mL.<br>|
| Active Comparator: Nutrient-dense formula<br>Feeding the infant or child with the nutrient-dense formula which is prepared by concentrating regular formula. | Dietary Supplement: Infant formula<br>* Regular infant formula will be concentrated to give a calorie density of about 90 kcal/100 mL.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Body weight of infant or child | Change from baseline at 2 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |