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

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Dietary Supplement: Infant formula

• Registration Number: NCT04795076
• Lead Sponsor: Shahid Beheshti University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-06
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-12
• Study Start: 2021-04-03
• Status Verified: 2022-02
• Primary Completion: 2022-02-09
• Study Completion: 2022-02-09
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Infant and children 6 to 24 months with CHD undergoing repair surgery
• Malnutrition (weight for age Z score ≤ -1)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard formula	Infant formula	Feeding the infant or child with the regular formula which is prepared with standard concentrations
Nutrient-dense formula	Infant formula	Feeding the infant or child with the nutrient-dense formula which is prepared by concentrating regular formula.

Primary Outcome Measures

Name	Time	Method
Weight	Change from baseline at 2 months	Body weight of infant or child

Secondary Outcome Measures

Name	Time	Method
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
IGF1	Change from baseline at 2 months	Serum IGF1
Head circumference	Change from baseline at 2 months	Head circumference

Trial Locations

Locations (1)

Rajaei Cardiovascular, Medical & Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of