The Effect of Transcatheter VSD Closure on Children's Appetite, Hormones and Growth

Study Overview
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Brief Summary
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In this study; Changes in appetite, hormones and growth of ventricular septal defect patients treated with non-surgical method were evaluated.

Detailed Description
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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.

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

Conditions
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Ventricular Septal Defect, Appetite Loss, Growth Delay

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients who underwent transcatheter VSD closure Exclusion Criteria: Chromosomal abnormalities Additional systemic disease Systemic infections

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient<br>Patients whose ventricular septal defect closed percutaneously. | |
| Control<br>Healthy children | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Z score | The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD | 6 months | 
| Height Z score | The change in the Z scores of the heights according to the age of the patients after the interventional closure of the VSD | 6 month | 
| Body mass index Z score | 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 | 6 month | 
| Ghrelin | Change in serum ghrelin level of patients after interventional closure of VSD | 6 month | 
| Leptin | Change in serum leptin level of patients after interventional closure of VSD | 6 month | 
| Visual analogue scale | 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. | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventricular septal defect, appetite, growth, interventional therapy