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

Shahid Beheshti University

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Dietary Supplement: Infant formula

Study type: Interventional

Funder types: Other

Identifiers

NCT04795076

22213

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups, including a placebo group

Standard formula

Placebo Comparator group

Description:

Feeding the infant or child with the regular formula which is prepared with standard concentrations

Treatment:

Dietary Supplement: Infant formula

Nutrient-dense formula

Active Comparator group

Description:

Feeding the infant or child with the nutrient-dense formula which is prepared by concentrating regular formula.

Treatment:

Dietary Supplement: Infant formula