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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05056285
Other study ID # PogacoDsppaAuch
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date April 30, 2022

Study information

Verified date September 2021
Source Assiut University
Contact Dalia Galal Mahran, Professor
Phone 01007120821
Email daliaym2001@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Down syndrome or Down's syndrome (DS), also known as trisomy 21, is a genetic disorder caused by the presence of all or part of a third copy of chromosome 21. It is usually associated with physical growth delays, mild to moderate intellectual disability, and characteristic facial features. The parents of the affected individual are usually genetically normal. The probability increases from less than 0.1% in 20-year-old mothers to 3% in those of age 45 .


Description:

People with DS may have some or all of these physical characteristics: a small chin, slanted eyes, poor muscle tone, a flat nasal bridge, a single crease of the palm, and a protruding tongue due to a small mouth and relatively large tongue. Other features include: a flat and wide face, a short neck, excessive joint flexibility, extra space between big toe and second toe, abnormal patterns on the fingertips and short fingers. Short stature is a characteristic feature of DS. Growth retardation of DS individuals starts prenatally. After birth, the growth velocity is most reduced between 6 months to 3 years . Growth charts specific for children with DS are important tools for routine medical follow-up, as well as early identification of pathological causes of growth retardation, and monitoring of growth promoting treatments. Growth charts for DS are available from different countries, for example, Italy, USA, Denmark, Sweden, Portugal, France, UK and Ireland and Saudi Arabia .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date April 30, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 4 Years
Eligibility Inclusion Criteria: - All Down syndrome children attending Assuit university less than four years with or without cardiovascular. Exclusion Criteria: - Any Down syndrome child more than four years.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (7)

Malt EA, Dahl RC, Haugsand TM, Ulvestad IH, Emilsen NM, Hansen B, Cardenas YE, Skøld RO, Thorsen AT, Davidsen EM. Health and disease in adults with Down syndrome. Tidsskr Nor Laegeforen. 2013 Feb 5;133(3):290-4. doi: 10.4045/tidsskr.12.0390. Review. English, Norwegian. — View Citation

Morris JK, Mutton DE, Alberman E. Revised estimates of the maternal age specific live birth prevalence of Down's syndrome. J Med Screen. 2002;9(1):2-6. — View Citation

Patterson D. Molecular genetic analysis of Down syndrome. Hum Genet. 2009 Jul;126(1):195-214. doi: 10.1007/s00439-009-0696-8. Epub 2009 Jun 13. Review. — View Citation

Perkins JA. Overview of macroglossia and its treatment. Curr Opin Otolaryngol Head Neck Surg. 2009 Dec;17(6):460-5. doi: 10.1097/MOO.0b013e3283317f89. Review. — View Citation

Piro E, Pennino C, Cammarata M, Corsello G, Grenci A, Lo Giudice C, Morabito M, Piccione M, Giuffrè L. Growth charts of Down syndrome in Sicily: evaluation of 382 children 0-14 years of age. Am J Med Genet Suppl. 1990;7:66-70. — View Citation

Sara VR, Gustavson KH, Annerén G, Hall K, Wetterberg L. Somatomedins in Down's syndrome. Biol Psychiatry. 1983 Jul;18(7):803-11. — View Citation

Weijerman ME, de Winter JP. Clinical practice. The care of children with Down syndrome. Eur J Pediatr. 2010 Dec;169(12):1445-52. doi: 10.1007/s00431-010-1253-0. Epub 2010 Jul 15. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The pattern of growth in Down syndrome patients Descriptive case series study 6 months
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