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

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Brief Title

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

Official Title

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

Brief Summary

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

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


Primary Outcome

Weight Z score


Condition

Ventricular Septal Defect


Study Arms / Comparison Groups

 Patient
Description:  Patients whose ventricular septal defect closed percutaneously.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

46

Start Date

July 16, 2018

Completion Date

January 1, 2020

Primary Completion Date

June 1, 2019

Eligibility Criteria

        Inclusion Criteria:

        Pediatric patients who underwent transcatheter VSD closure

        Exclusion Criteria:

          -  Chromosomal abnormalities

          -  Additional systemic disease

          -  Systemic infections
      

Gender

All

Ages

3 Months - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Onur Tasci, , 

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT05200910

Organization ID

7645


Responsible Party

Principal Investigator

Study Sponsor

Kayseri City Hospital


Study Sponsor

Onur Tasci, Principal Investigator, TC Erciyes University


Verification Date

January 2022