跳至主要内容
临床试验/NCT04903964
NCT04903964已完成不适用

The Effect of Individualized Nutrition Training Given to the Families of Children With Congenital Heart Disease (CHD) in the Post-Operative Period on Their Growth and Development

Cukurova University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Body weight measurement of growth parameter

研究概览

简要总结

The Effect of Individualized Nutrition Training Given to the Families of Children with Congenital Heart Disease (CHD) in the Post-Operative Period on their Growth and Development This study was conducted experimentally to determine the effects of individualized nutrition training given to mothers of children who had surgery for CHD on their growth and development.

详细描述

The Effect of Individualized Nutrition Training Given to the Families of Children with Congenital Heart Disease (CHD) in the Post-Operative Period on their Growth and Development This study was conducted experimentally to determine the effects of individualized nutrition training given to mothers of children who had surgery for CHD on their growth and development.

The data of the study were collected at Çukurova University Medical Faculty Balcalı Hospital Cardiovascular Surgery between 20/01/2021-30/06/2021. The research was conducted by interviewing the families of 42 children with congenital heart disease. Personal information form, growth parameters and Ankara Developmental Screening Inventory were applied to three groups formed as two experimental and control groups by randomization method. Family-centered care and individualized nutrition training were applied to the first experimental group who was fed orally and and the second experimental group orally and nutritionally fed. These trainings were about nutritional contents suitable for the age of the baby, the way of preparing the food and meeting the calorie needs of the baby. No training was given to the control group during the research process. The growth and development parameters of all three groups were evaluated and the effect of education was examined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None (Care Provider, Investigator)

入排标准

年龄范围
30 Days 至 3 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Congenital heart disease,
  • •Born on time (38-42 weeks)
  • •Over 2.300 gr.
  • •fed with additional nutritional support to oral and oral nutrition,
  • •Decided to have surgery,
  • •0-3 years old,
  • •The children and their families who were followed up in the post-operative service were included.

排除标准

  • •No congenital heart disease
  • •Not planned to have surgery,
  • •over 3 years old,
  • •Children with additional congenital malformation, dysmorphic syndrome, chromosomal disease, severe infection, hypothyroidism and similar disorders that may cause growth and development retardation were excluded from the study.

研究组 & 干预措施

control group

No Intervention

While collecting research data on the specified dates; Comparison group (KG) will be selected as many as the number of volunteers who want to participate in the research. No nutritional attempt will be made to the child included in this group. The parameters used in the evaluation of growth (height, head and chest circumference measurement) and the Ankara Development Screening Inventory (AGTE) will be applied to children aged 0-3 who are followed up due to congenital heart disease.

Experimental Group 1: Orally Fed Group Receiving Individualized Nutrition Education

Experimental

This group consisted of children aged 0-3 years with congenital heart disease who were fed orally according to their age and clinical condition. A researcher-developed questionnaire, anthropometric growth measurements (body weight, height, head circumference, and chest circumference), and the Ankara Developmental Screening Inventory (ADSI/AGTE) were administered to the children and their families. Mothers received individualized family-centered nutrition education prepared by the researcher, including breastfeeding, complementary feeding, age-appropriate nutrition, and nutritional requirements after congenital heart surgery. Following the educational intervention, anthropometric measurements were repeated on postoperative day 1, day 7, and day 14 to evaluate growth outcomes. Developmental status was assessed using the Ankara Developmental Screening Inventory.

干预措施: family-centered nutrition education (Other)

Experimental Group 2: Nutrition Education Plus Nutritional Support Group

Experimental

Arm/Group Description:

This group consisted of children aged 0-3 years with congenital heart disease who received individualized nutrition education in addition to nutritional support, including fortified breast milk, oral nutritional supplements, and/or enteral nutritional support according to their nutritional requirements. A researcher-developed questionnaire, anthropometric growth measurements (body weight, height, head circumference, and chest circumference), and the Ankara Developmental Screening Inventory (ADSI/AGTE) were administered to the children and their families. Mothers received individualized family-centered nutrition education prepared by the researcher. Following the intervention, anthropometric measurements were repeated on postoperative day 1, day 7, and day 14 to evaluate growth outcomes. Developmental status was assessed using the Ankara Developmental Screening Inventory.

干预措施: family-centered nutrition education (Other)

结局指标

主要结局

Body weight measurement of growth parameter

时间窗: every weeek up to 1 months

In order to determine the physical growth status of the babies, kilograms (in kg) will be measured by the researcher. These measurement results will be given as average Z scores ((kg) type and percentile values. Body weight is measured on an Oncomed electronic scale by removing the clothing and subtracting the dry weight of the ultra-prima brand diaper.

次要结局

  • Height measurement of growth parameter(every weeek up to 1 months)
  • Head circumference measurement of growth parameters(every weeek up to 1 months)

研究者

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

Emel Yürük

Lecturer

Cukurova University

研究点 (1)

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