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

NCT04795076 — Not applicable, Completed, 65 participants, Shahid Beheshti University

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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

Registry	NCT04795076
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	65 (Actual)
Sponsor	Shahid Beheshti University (Other)
Conditions	Congenital Heart Disease
Interventions	Infant formula (Dietary supplement)
Dates	start 2021-04-03, primary completion 2022-02-09, completion 2022-02-09, first posted 2021-03-12, last updated 2022-02-10
Locations	1 site in Iran

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Standard formula	Placebo comparator	Dietary Supplement: Infant formula	Feeding the infant or child with the regular formula which is prepared with standard concentrations
Nutrient-dense formula	Active comparator	Dietary Supplement: Infant formula	Feeding the infant or child with the nutrient-dense formula which is prepared by concentrating regular formula.

Infant formula (Dietary supplement): Regular infant formula will be concentrated to give a calorie density of about 90 kcal/100 mL.

+Outcome measures

Primary outcomes

Weight [Change from baseline at 2 months]: Body weight of infant or child

Secondary outcomes

Length [Change from baseline at 2 months]: Recumbent length of infant or child
Mid-arm circumference [Change from baseline at 2 months]: mid upper-arm circumference of infant or child
Head circumference [Change from baseline at 2 months]: Head circumference
IGF1 [Change from baseline at 2 months]: Serum IGF1

+Eligibility

Sex: All, ages: 6 Months to 24 Months

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)

+Locations (1)

Facility	City	Country	Status
Rajaei Cardiovascular, Medical & Research Center	Tehran	Iran