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

NCT04795076 | Completed

• 1 other identifier: 22213
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Weight

  Body weight of infant or child

  Change from baseline at 2 months

Secondary Outcomes (4)

• Length

  Change from baseline at 2 months

• Mid-arm circumference

  Change from baseline at 2 months

• Head circumference

  Change from baseline at 2 months

• IGF1

  Change from baseline at 2 months

Study Arms (2)

Standard formula

PLACEBO COMPARATOR

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

Dietary Supplement: Infant formula

Nutrient-dense formula

ACTIVE COMPARATOR

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

Dietary Supplement: Infant formula

Interventions

Infant formula DIETARY_SUPPLEMENT

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

Nutrient-dense formula; Standard formula

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Allergy to cow's milk protein
• Preterm infant or infant weighing less than 2500 grams at birth
• Children with chromosomal disease (Down, Turner)

Sponsors & Collaborators

• Shahid Beheshti University: lead

Study Sites (1)

Rajaei Cardiovascular, Medical & Research Center

Tehran, Iran

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Infant Formula

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 12, 2021
• Study Start: April 3, 2021
• Primary Completion: February 9, 2022
• Study Completion: February 9, 2022
• Last Updated: February 10, 2022

Record last verified: 2022-02

Locations

IR (1)