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临床试验/NCT04795076
NCT04795076已完成不适用

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

Shahid Beheshti University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2021年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
Weight

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infant and children 6 to 24 months with CHD undergoing repair surgery
  • Malnutrition (weight for age Z score ≤ -1)

排除标准

  • Allergy to cow's milk protein
  • Preterm infant or infant weighing less than 2500 grams at birth
  • Children with chromosomal disease (Down, Turner)

结局指标

主要结局

Weight

时间窗: Change from baseline at 2 months

Body weight of infant or child

次要结局

  • Length(Change from baseline at 2 months)
  • Mid-arm circumference(Change from baseline at 2 months)
  • IGF1(Change from baseline at 2 months)
  • Head circumference(Change from baseline at 2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Javad Nasrollahzadeh

Associate Professor

Shahid Beheshti University of Medical Sciences

研究点 (1)

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