Short StatureNCT04754516
Diagnosis of Short Stature in Children : Study of a Cohort of Small-sized Consulting Patients
An observational study of Short Stature and Growth Delay, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Many patients consult in pediatric endocrinology because of their small size. In the majority of cases, this growth delays can be explained by a hormonal, gastroenterological cause, or a chronic disease. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Short Stature, Growth Delay
- How many people
- 479 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 8 Feb 2021
- 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 17 years
- No healthy volunteers
- Child
Study population: All the children who consulted for the first time because of their short stature, in pediatric endocrinology at the Montpellier University Hospital between January 2017 and December 2018
Who may be able to join
- All the children who consulted for the first time because of their short stature, in pediatric endocrinology at the Montpellier University Hospital between January 2017 and December 2018
Who cannot join
- Patient already undergoing specialized medical follow-up due to his small size Major patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosis of Short Stature in Children : Study of a Cohort of Small-sized Consulting Patients in 2017 and 2018
Many patients consult in pediatric endocrinology because of their small size. In the majority of cases, this growth delays can be explained by a hormonal, gastroenterological cause, or a chronic disease.
Sometimes the reason for stunted growth can be constitutional bone disease, a genetic cause of short stature that is still underdiagnosed.
The investigators wish to describe and take stock of the various additional analyzes carried out and the various diagnoses made in patients who consulted in endocrino-pediatrics at the Montpellier University Hospital due to their short stature, in 2017 and 2018, in order to better screen patients with constitutional bone disease
- Conditions
- Short Stature, Growth Delay
- Keywords
- Constitutional bone disease, Pediatrics
- Medical subject headings
- Dwarfism
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the prevalence of different diagnoses of stature delay in children
Study the prevalence of different diagnoses of stature delay in children
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Jan 2021
- Primary completion31 Jan 2021
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short StatureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyril Amouroux, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754516
- Sponsor's protocol ID
- RECHMPL21_0065
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Short Stature in Children : Study of a Cohort of Small-sized Consulting Patients in 2017 and 2018
- ClinicalTrials.gov ID
- NCT04754516
- Acronym / sponsor ID
- RECHMPL21_0065
- Conditions
- Short Stature, Growth Delay
- Keywords
- Constitutional bone disease, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 15 Feb 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.
Many patients consult in pediatric endocrinology because of their small size. In the majority of cases, this growth delays can be explained by a hormonal, gastroenterological cause, or a chronic disease.
Sometimes the reason for stunted growth can be constitutional bone disease, a genetic cause of short stature that is still underdiagnosed.
The investigators wish to describe and take stock of the various additional analyzes carried out and the various diagnoses made in patients who consulted in endocrino-pediatrics at the Montpellier University Hospital due to their short stature, in 2017 and 2018, in order to better screen patients with constitutional bone disease
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 17 years
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All the children who consulted for the first time because of their short stature, in pediatric endocrinology at the Montpellier University Hospital between January 2017 and December 2018
Key inclusion criteria (1 listed)
- All the children who consulted for the first time because of their short stature, in pediatric endocrinology at the Montpellier University Hospital between January 2017 and December 2018
Key exclusion criteria (1 listed)
- Patient already undergoing specialized medical follow-up due to his small size Major patient
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
Study the prevalence of different diagnoses of stature delay in children
Time frame: 1 day
Study the prevalence of different diagnoses of stature delay in children
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Cyril Amouroux study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Stature and Growth Delay, run by University Hospital, Montpellier at 1 site in France.
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: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the prevalence of different diagnoses of stature delay in children (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2021.