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

February 9, 2022 updated by: Javad Nasrollahzadeh, Shahid Beheshti University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length
Time Frame: Change from baseline at 2 months
Recumbent length of infant or child
Change from baseline at 2 months
Mid-arm circumference
Time Frame: Change from baseline at 2 months
mid upper-arm circumference of infant or child
Change from baseline at 2 months
Head circumference
Time Frame: Change from baseline at 2 months
Head circumference
Change from baseline at 2 months
IGF1
Time Frame: Change from baseline at 2 months
Serum IGF1
Change from baseline at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 3, 2021

Primary Completion (ACTUAL)

February 9, 2022

Study Completion (ACTUAL)

February 9, 2022

Study Registration Dates

First Submitted

March 6, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (ACTUAL)

March 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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