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

NCT05200910 | Completed

• 1 other identifier: 7645
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventricular Septal Defect; Appetite Loss; Growth Delay

Keywords

ventricular septal defect; appetite; growth; interventional therapy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Patient

Patients whose ventricular septal defect closed percutaneously.

Control

Healthy children

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients who underwent transcatheter VSD closure in our institute and whose growth was followed for 6 months as patient group. Healthy children without appetite or growth retardation were included in the study as a control group.

You may qualify if:

• Pediatric patients who underwent transcatheter VSD closure

You may not qualify if:

• Chromosomal abnormalities
• Additional systemic disease
• Systemic infections

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Süleyman Sunkak

Kayseri, Kocasinan, 38030, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples, plasma, serum

MeSH Terms

Conditions

Heart Septal Defects, Ventricular; Anorexia

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Onur Tasci

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist (pediatric cardiolog)

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 21, 2022
• Study Start: July 16, 2018
• Primary Completion: June 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

TU (1)