Back to resultsEffect of Feeding With Nutrient Dense Formula in Malnourished Infants and Children With Congenital Heart Defects
Primary Purpose
Congenital Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Infant formula
Sponsored by
About this trial
This is an interventional supportive care trial for Congenital Heart Disease
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)
Sites / Locations
- Rajaei Cardiovascular, Medical & Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Standard formula
Nutrient-dense formula
Arm Description
Feeding the infant or child with the regular formula which is prepared with standard concentrations
Feeding the infant or child with the nutrient-dense formula which is prepared by concentrating regular formula.
Outcomes
Primary Outcome Measures
Weight
Body weight of infant or child
Secondary Outcome Measures
Length
Recumbent length of infant or child
Mid-arm circumference
mid upper-arm circumference of infant or child
Head circumference
Head circumference
IGF1
Serum IGF1
Full Information
NCT ID
NCT04795076
First Posted
March 6, 2021
Last Updated
February 9, 2022
Sponsor
Shahid Beheshti University
1. Study Identification
Unique Protocol Identification Number
NCT04795076
Brief Title
Effect of Feeding With Nutrient Dense Formula in Malnourished Infants and Children With Congenital Heart Defects
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 3, 2021 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
February 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard formula
Arm Type
Placebo Comparator
Arm Description
Feeding the infant or child with the regular formula which is prepared with standard concentrations
Arm Title
Nutrient-dense formula
Arm Type
Active Comparator
Arm Description
Feeding the infant or child with the nutrient-dense formula which is prepared by concentrating regular formula.
Intervention Type
Dietary Supplement
Intervention Name(s)
Infant formula
Intervention Description
Regular infant formula will be concentrated to give a calorie density of about 90 kcal/100 mL.
Primary Outcome Measure Information:
Title
Weight
Description
Body weight of infant or child
Time Frame
Change from baseline at 2 months
Secondary Outcome Measure Information:
Title
Length
Description
Recumbent length of infant or child
Time Frame
Change from baseline at 2 months
Title
Mid-arm circumference
Description
mid upper-arm circumference of infant or child
Time Frame
Change from baseline at 2 months
Title
Head circumference
Description
Head circumference
Time Frame
Change from baseline at 2 months
Title
IGF1
Description
Serum IGF1
Time Frame
Change from baseline at 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Rajaei Cardiovascular, Medical & Research Center
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Feeding With Nutrient Dense Formula in Malnourished Infants and Children With Congenital Heart Defects
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