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

• Sponsor: Shahid Beheshti University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04795076
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.3
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease	Dietary Supplement: Infant formula	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Apr 3, 2021
• Actual Primary Completion Date: Feb 9, 2022
• Actual Study Completion Date: Feb 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Standard formula Feeding the infant or child with the regular formula which is prepared with standard concentrations	Dietary Supplement: Infant formula; Regular infant formula will be concentrated to give a calorie density of about 90 kcal/100 mL.
Active Comparator: Nutrient-dense formula Feeding the infant or child with the nutrient-dense formula which is prepared by concentrating regular formula.	Dietary Supplement: Infant formula; Regular infant formula will be concentrated to give a calorie density of about 90 kcal/100 mL.

Outcome Measures

Primary Outcome Measures

1. Weight [Change from baseline at 2 months]

   Body weight of infant or child

Secondary Outcome Measures

1. Length [Change from baseline at 2 months]

   Recumbent length of infant or child

2. Mid-arm circumference [Change from baseline at 2 months]

   mid upper-arm circumference of infant or child

3. Head circumference [Change from baseline at 2 months]

   Head circumference

4. IGF1 [Change from baseline at 2 months]

   Serum IGF1

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 24 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rajaei Cardiovascular, Medical & Research Center	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Shahid Beheshti University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Javad Nasrollahzadeh, Associate Professor, Shahid Beheshti University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT04795076
• Other Study ID Numbers: 22213
• First Posted: Mar 12, 2021
• Last Update Posted: Feb 10, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital

Study Results

No Results Posted as of Feb 10, 2022