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

Ventricular Septal Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05200910
• Other study ID #: 7645
• Status: Completed
• Start date: July 16, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2022
• Source: Kayseri City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

Inclusion Criteria:

Pediatric patients who underwent transcatheter VSD closure

Exclusion Criteria:

• Chromosomal abnormalities

• Additional systemic disease

• Systemic infections

Related Conditions & MeSH terms

• Appetite Loss
• Growth Delay
• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Ventricular Septal Defect

Locations

Country	Name	City	State
Turkey	Süleyman Sunkak	Kayseri	Kocasinan

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Ghrelin	Change in serum ghrelin level of patients after interventional closure of VSD	6 month
Primary	Leptin	Change in serum leptin level of patients after interventional closure of VSD	6 month
Primary	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