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临床试验/NCT05200910
NCT05200910已完成不适用

Nutritional, Hormonal and Anthropometric Evaluation of Children After Transcatheter VSD Closure

Kayseri City Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年7月16日最近更新:
适应症

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

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

发起方
Kayseri City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

süleyman sunkak

Specialist (pediatric cardiolog)

Kayseri City Hospital

研究点 (1)

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