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

NCT ID: NCT04795076

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-03
• Study Completion Date: 2022-02-09

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.

Conditions

Congenital Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard formula

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

Group Type: PLACEBO_COMPARATOR

Infant formula

Intervention Type: DIETARY_SUPPLEMENT

Regular infant formula will be concentrated to give a calorie density of about 90 kcal/100 mL.

Nutrient-dense formula

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

Group Type: ACTIVE_COMPARATOR

Infant formula

Intervention Type: DIETARY_SUPPLEMENT

Regular infant formula will be concentrated to give a calorie density of about 90 kcal/100 mL.

Interventions

Infant formula

Regular infant formula will be concentrated to give a calorie density of about 90 kcal/100 mL.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University

OTHER

Sponsor Role: lead

Responsible Party

Javad Nasrollahzadeh

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rajaei Cardiovascular, Medical & Research Center

Tehran, , Iran

Countries

Iran

Other Identifiers

22213

Identifier Type: -

Identifier Source: org_study_id