Nutritional, Hormonal and Anthropometric Evaluation of Children After Transcatheter VSD Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Weight Z score
研究概览
简要总结
In this study; Changes in appetite, hormones and growth of ventricular septal defect patients treated with non-surgical method were evaluated.
详细描述
The study included 20 patients whose ventricular septal defect closed percutaneously and 26 children as control group. The symptoms, anthropometric measurements and laboratory tests of patient group were recorded at initial, 1st month and 6th months after closure.
Anthropometric measurements; weight for age (WFA), height for age (HFA), body mass index (BMI) and their z scores, triceps skinfold thickness (TSF) and mid-upper arm circumference (MUAC) were recorded on admission. Patients with weight for height z score less than -2 were defined as malnutrition.
Questions about the symptoms like appetite, weight gain, frequency of illness, rate of breathing, fatigue were asked to all parents at initial. These questionnaires15 and visual analogue scale (for appetite) were repeated at 1st and 6th month visits.
During the initial evaluation, approximately 6 ml of venous blood samples were taken between 9:00-10:00 am after an average of 10 hours fasting. On the same day, IGFBP-3, Ghrelin and leptin,fasting blood glucose, insulin, IGF-1, IGFBP-3, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total protein, and albumin were measured.
Anthropometric measurements and laboratory tests were repeated at 1st and 6th month visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients who underwent transcatheter VSD closure
排除标准
- •Chromosomal abnormalities
- •Additional systemic disease
- •Systemic infections
结局指标
主要结局
Weight Z score
时间窗: 6 months
The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD
Height Z score
时间窗: 6 month
The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD
Ghrelin
时间窗: 6 month
Change in serum ghrelin level of patients after interventional closure of VSD
Body mass index Z score
时间窗: 6 month
The change in the Z scores of the body mass index according to the age of the patients after the interventional closure of the VSD
Leptin
时间窗: 6 month
Change in serum leptin level of patients after interventional closure of VSD
Visual analogue scale
时间窗: 6 month
Change in Visual analogue scale of patients and parent after interventional closure of VSD. Values in this scale vary between 0-100 mm, values close to '0' are composed of words and images expressing a decrease in the patient's appetite, values close to '100' representing an increase in appetite.
次要结局
未报告次要终点
研究者
süleyman sunkak
Specialist (pediatric cardiolog)
Kayseri City Hospital
