NCT05056285

Brief 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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

September 15, 2021

Last Update Submit

September 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The pattern of growth in Down syndrome patients

    Descriptive case series study

    6 months

Study Arms (1)

Down syndrome less than four years Group

Eligibility Criteria

AgeUp to 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

1. Inclusion criteria: All Down syndrome children attending Assuit university less than four years with or without cardiovascular . 2. Exclusion criteria: Any Down syndrome child more than four years. This is a descriptive case series study.

You may qualify if:

  • All Down syndrome children attending Assuit university less than four years with or without cardiovascular.

You may not qualify if:

  • Any Down syndrome child more than four years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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. doi: 10.1136/jms.9.1.2.

    PMID: 11943789BACKGROUND
  • 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.

    PMID: 19713845BACKGROUND
  • Malt EA, Dahl RC, Haugsand TM, Ulvestad IH, Emilsen NM, Hansen B, Cardenas YE, Skold 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. English, Norwegian.

    PMID: 23381164BACKGROUND
  • Sara VR, Gustavson KH, Anneren G, Hall K, Wetterberg L. Somatomedins in Down's syndrome. Biol Psychiatry. 1983 Jul;18(7):803-11. No abstract available.

    PMID: 6225471BACKGROUND
  • Piro E, Pennino C, Cammarata M, Corsello G, Grenci A, Lo Giudice C, Morabito M, Piccione M, Giuffre 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. doi: 10.1002/ajmg.1320370712.

    PMID: 2149977BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Dalia Galal Mahran, Professor

CONTACT

Hekma Saad Farghaly, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Amira Gaber Osman

Study Record Dates

First Submitted

September 15, 2021

First Posted

September 24, 2021

Study Start

October 1, 2021

Primary Completion

March 31, 2022

Study Completion

April 30, 2022

Last Updated

September 24, 2021

Record last verified: 2021-09