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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04795076

Enrollment

Registered

2021-03-12

Start date

2021-04-03

Completion date

2022-02-09

Last updated

2022-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

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.

Interventions

DIETARY_SUPPLEMENTInfant formula

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 24 Months

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Weight	Change from baseline at 2 months	Body weight of infant or child

Secondary

Measure	Time frame	Description
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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026