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Completed

NCT Number: NCT04795076

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

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajaei Cardiovascular, Medical & Research Center

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Infant Formula

Dietary Supplement

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

Primary outcomes

  1. Weight

    Time frame: Change from baseline at 2 months

    Body weight of infant or child

Secondary outcomes

  1. Length

    Time frame: Change from baseline at 2 months

    Recumbent length of infant or child

  2. Mid-arm circumference

    Time frame: Change from baseline at 2 months

    mid upper-arm circumference of infant or child

  3. Head circumference

    Time frame: Change from baseline at 2 months

    Head circumference

  4. IGF1

    Time frame: Change from baseline at 2 months

    Serum IGF1

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 12, 2021
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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