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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795076
• Other study ID #: 22213
• Status: Completed
• Phase: N/A
• Start date: April 3, 2021
• Est. completion date: February 9, 2022

Study information

• Verified date: February 2022
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 9, 2022
• Est. primary completion date: February 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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)

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rajaei Cardiovascular, Medical & Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Body weight of infant or child	Change from baseline at 2 months
Secondary	Length	Recumbent length of infant or child	Change from baseline at 2 months
Secondary	Mid-arm circumference	mid upper-arm circumference of infant or child	Change from baseline at 2 months
Secondary	Head circumference	Head circumference	Change from baseline at 2 months
Secondary	IGF1	Serum IGF1	Change from baseline at 2 months