An observational study in Congenital Heart Defects, Down Syndrome and Gross Motor Development Delay, sponsored by Atılım University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Months to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-13.
Sponsored by Atılım University · Observational
Congenital heart diseases (CHD) are detected in 40-60% of individuals with Down syndrome (DS) and increase the risk of developmental delay in the presence of syndromes. The aim of the study was to compare cardiopulmonary parameters, gross motor development and hand grip strength in DS children with and without CHD. Demographic variables, cardiopulmonary parameters and echocardiographic values were recorded. Gross motor development was evaluated with Gross Motor Function Measure (GMFM-88). Hand grip strength was measured with the Baseline Pneumatic Bulb Dynamometer.
1,031 studies on the registry are indexed under Heart Defects, Congenital; 262 are open to participants now.
This study's enrollment of 28 is below the median of 120 across 459 observational studies indexed under Heart Defects, Congenital.
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Children with down syndrome
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Exclusion Criteria:
Diagnostic Test: evaluation of cardiopulmonary parameters, gross motor development and hand grip strength
Diagnostic Test: evaluation of cardiopulmonary parameters, gross motor development and hand grip strength
Gross motor development was evaluated with Gross Motor Function Measure (GMFM-88). Hand grip strength was measured with the Baseline Pneumatic Bulb Dynamometer. Cardiopulmonary parameters values was evaluated with echocardiography.
Gross Motor Function Measure-88
Gross motor development of the participants was evaluated with the Gross Motor Function Measure-88 questionnaire. The value as a percentage was obtained as a result of the survey. Gross Motor Function Measure-88 consists of 5 sections that include the evaluation of Lying \& Rolling, Sitting, Crawling \& Kneeling, Standing, Walking, Running \& Jumping activities. Each item in the sections consists of a 4-point scale. Scores for each section are summed and divided by 5.The maximum score on the scale is 100. A high score indicates good gross motor development. 0 = does not initiate 1. = initiates 2. = partially completes 3. = completes
Time frame: october 2020- june 2021
Bulb Dynamometer
Hand grip strength was measured with a Baseline Pneumatic Bulb Dynamometer (Fabrication Enterprises INC, Elmsford, NY USA). With a bulb dynamometer, the spherical grip force is measured using a rubber balloon tip. The bulb dynamometer has 3 removable sizes. The values measured on the manometer are recorded in kPa. The measurement is repeated 3 times and the highest value is taken.
Time frame: october 2020- june 2021
Left ventricular ejection fraction (EF)
Echocardiographic findings performed in the last 6 months were evaluated by a pediatric cardiologist. It is obtained by dividing the difference in left ventricular volume at end-diastolic and end-systolic by the end-diastolic left ventricular volume. Left ventricular ejection fraction (EF) indicate the systolic function of the left ventricle. Ejection fraction value show as a percentage (%). The ejection fraction normal value is between 50 percent and 70 percent.
Time frame: october 2020- june 2021
Interventricular septum wall thickness (IVS)
Echocardiographic findings performed in the last 6 months were evaluated by a pediatric cardiologist. It is important in the risk classification potential of left ventricular systolic function. Its value is show as millimeters (mm).
Time frame: october 2020- june 2021
Left ventricular end-diastolic diameter (LVDd)
Echocardiographic findings performed in the last 6 months were evaluated by a pediatric cardiologist. It is important in the risk classification potential of left ventricular systolic function. Its value is show as millimeters (mm).
Time frame: october 2020- june 2021
Fractional shortening (FS)
Echocardiographic findings performed in the last 6 months were evaluated by a pediatric cardiologist. Fractional shortening evaluates left ventricular systolic function. Fractional shortening value show as a percentage (%). The value of normal fractional shortening in children is between 28-44%.
Time frame: october 2020- june 2021
Wang Respiratory Score
The Wang respiratory score assesses respiratory frequency, wheezing, retraction, and general condition. parameters are scored between 0-3 and summed. A higher score indicates that the situation is getting severe.
Time frame: october 2020- june 2021
Plan to share: No
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Atılım University