Growth DisordersNCT05056285
Pattern of Growth and Characteristics of Down Syndrome Pediatrics Patients
An observational study of Growth Disorders, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages Up to 4 years
- Conditions the study is for
- Growth Disorders
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 30 Apr 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- All Down syndrome children attending Assuit university less than four years with or without cardiovascular.
Who cannot join
- Any Down syndrome child more than four years.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pattern of Growth and Characteristics of Down Syndrome Pediatrics Patients Attending Assuit University Children Hospital
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 .
Read the detailed 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 .
- Conditions
- Growth Disorders
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Down syndrome less than four years Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pattern of growth in Down syndrome patients
Descriptive case series study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Growth DisordersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Gaber Osman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056285
- Sponsor's protocol ID
- PogacoDsppaAuch
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11943789Perkins JA. Overview of macroglossia and its treatment. Curr Opin Otolaryngol Head Neck Surg. 2009 Dec;17(6):460-5. doi: 10.1097/MOO.0b013e3283317f89.
PubMed 19713845Malt 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.
PubMed 23381164Sara 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.
PubMed 6225471Piro 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.
PubMed 2149977Patterson 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.
PubMed 19526251Weijerman 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.
PubMed 20632187
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Growth and Characteristics of Down Syndrome Pediatrics Patients Attending Assuit University Children Hospital
- ClinicalTrials.gov ID
- NCT05056285
- Acronym / sponsor ID
- PogacoDsppaAuch
- Conditions
- Growth Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed 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 .
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Down syndrome less than four years Group | – | – |
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- All Down syndrome children attending Assuit university less than four years with or without cardiovascular.
Key exclusion criteria (1 listed)
- Any Down syndrome child more than four years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The pattern of growth in Down syndrome patients
Time frame: 6 months
Descriptive case series study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Background: PubMed 11943789Morris 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.
- Background: PubMed 19713845Perkins JA. Overview of macroglossia and its treatment. Curr Opin Otolaryngol Head Neck Surg. 2009 Dec;17(6):460-5. doi: 10.1097/MOO.0b013e3283317f89.
- Background: PubMed 23381164Malt 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.
- Background: PubMed 6225471Sara 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.
- Background: PubMed 2149977Piro 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.
- Results publication: PubMed 19526251Patterson 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.
- Results publication: PubMed 20632187Weijerman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Disorders, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia Galal Mahran, Professor (01007120821, daliaym2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pattern of growth in Down syndrome patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05056285, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.