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

NCT ID: NCT05200910

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-16

Study Completion Date

2020-01-01

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.

Conditions

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Ventricular Septal Defect Appetite Loss Growth Delay

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient

Patients whose ventricular septal defect closed percutaneously.

No interventions assigned to this group

Control

Healthy children

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Pediatric patients who underwent transcatheter VSD closure

Exclusion Criteria

* Chromosomal abnormalities
* Additional systemic disease
* Systemic infections
Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kayseri City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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süleyman sunkak

Specialist (pediatric cardiolog)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Onur Tasci

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Locations

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Süleyman Sunkak

Kayseri, Kocasinan, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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7645

Identifier Type: -

Identifier Source: org_study_id

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