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

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

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

Study Overview

• Status: Completed
• Conditions: Ventricular Septal Defect; Appetite Loss; Growth Delay

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Turkey
  • Kocasinan
    • Kayseri, Kocasinan, Turkey, 38030
      • Süleyman Sunkak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

Pediatric patients who underwent transcatheter VSD closure

Exclusion Criteria:

• Chromosomal abnormalities
• Additional systemic disease
• Systemic infections

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; Healthy children
Patient; Patients whose ventricular septal defect closed percutaneously.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kayseri City Hospital
• Investigators: Principal Investigator: Onur Tasci, TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: appetite; growth; ventricular septal defect; interventional therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Septal Defects, Ventricular
• Other Study ID Numbers: 7645

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No