Down SyndromeARBT21NCT06336577
Infectious and Non-infectious Lower Respiratory Diseases in Children With Down Syndrome Followed in Pediatric Pulmonology Consultations in Ile-de-France
An observational study of Down Syndrome, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The purpose of this study is to describe infectious and non-infectious lower respiratory tract diseases in children with Down syndrome followed in pediatric pulmonology consultations in Ile de France. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- lower respiratory tract disease
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2024to 26 Jun 2024
- 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 1 day to 17 years
- All sexes
- Child
Study population: children with Down syndrome, who were hospitalized for respiratory problems and who had subsequent pediatric pulmonology follow-up between 2013 and 2023
Who may be able to join
- Child from 0 to 17 years old
- Carrier of Down syndrome confirmed by karyotype
- Having had follow-up in a pediatric pulmonology consultation for an infectious or non-infectious lower respiratory tract
- Not exclusively presenting upper respiratory otorhinolaryngological damage
Who cannot join
- Patient under guardianship or curators
- Adult or holders of parental authority informed of the study and having objected to it
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to describe infectious and non-infectious lower respiratory tract diseases in children with Down syndrome followed in pediatric pulmonology consultations in Ile de France.
Read the detailed description
Down syndrome is the most common chromosomal abnormality, affecting 600 to 800 births per year. It results in a clinical picture that combines developmental delay, mental deficiency, facial dysmorphism and visceral malformations.
Optimal medical care of Down syndrome patients requires a good knowledge of the different systems affected by the disease, particularly respiratory damage.
Numerous articles have been published describing upper respiratory problems in children with Down syndrome. On the other hand, lower respiratory problems causing significant morbidity and mortality remain underestimated and poorly understood in this population.
The objective of this study is to describe lower respiratory problems in patients with T21, in order to improve their management.
This study will also make it possible to describe more precisely the impact that these attacks have on Down syndrome patients.
This study also describe the associated extra-respiratory disorders to improve overall care Finally, the respiratory care of these patients will be described, with the aim of standardizing practices.
- Conditions
- Down Syndrome
- Being tested
- lower respiratory tract disease
- Keywords
- Down syndrome, children, lower respiratory diseases, respiratory infection, respiratory syncytial virus, hemosiderosis, asthma, bronchiolitis
- Medical subject headings
- Down Syndrome, Respiratory Tract Infections, Hemosiderosis, Asthma, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower respiratory tract diseaseOther
lower respiratory tract disease
What is being measured
The primary outcome is the main question the study is designed to answer.
distribution of lower respiratory tract diseases
number
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start28 Mar 2024
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yousra MESBAHI, MD, Principal investigator, C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336577
- Sponsor's protocol ID
- 2024/0003
- Acronym
- ARBT21
- Status last verified
- Aug 2024
- First submitted
- 22 Mar 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infectious and Non-infectious Lower Respiratory Diseases in Children With Down Syndrome Followed in Pediatric Pulmonology Consultations in Ile-de-France
- ClinicalTrials.gov ID
- NCT06336577
- Acronym / sponsor ID
- ARBT21 / 2024/0003
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, children, lower respiratory diseases, respiratory infection, respiratory syncytial virus, hemosiderosis, asthma, bronchiolitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 28 Mar 2024 (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.
The purpose of this study is to describe infectious and non-infectious lower respiratory tract diseases in children with Down syndrome followed in pediatric pulmonology consultations in Ile de France.
Detailed description
Down syndrome is the most common chromosomal abnormality, affecting 600 to 800 births per year. It results in a clinical picture that combines developmental delay, mental deficiency, facial dysmorphism and visceral malformations.
Optimal medical care of Down syndrome patients requires a good knowledge of the different systems affected by the disease, particularly respiratory damage.
Numerous articles have been published describing upper respiratory problems in children with Down syndrome. On the other hand, lower respiratory problems causing significant morbidity and mortality remain underestimated and poorly understood in this population.
The objective of this study is to describe lower respiratory problems in patients with T21, in order to improve their management.
This study will also make it possible to describe more precisely the impact that these attacks have on Down syndrome patients.
This study also describe the associated extra-respiratory disorders to improve overall care Finally, the respiratory care of these patients will be described, with the aim of standardizing practices.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- children with Down syndrome, who were hospitalized for respiratory problems and who had subsequent pediatric pulmonology follow-up between 2013 and 2023
Key inclusion criteria (4 listed)
- Child from 0 to 17 years old
- Carrier of Down syndrome confirmed by karyotype
- Having had follow-up in a pediatric pulmonology consultation for an infectious or non-infectious lower respiratory tract
- Not exclusively presenting upper respiratory otorhinolaryngological damage
Key exclusion criteria (2 listed)
- Patient under guardianship or curators
- Adult or holders of parental authority informed of the study and having objected to it
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lower respiratory tract diseaselower respiratory tract disease | Other | – |
Primary outcome
distribution of lower respiratory tract diseases
Time frame: at day 0
number
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 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Down Syndrome
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Down Syndrome
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.
Yousra MESBAHI, MD principal investigator
C
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 Down Syndrome, run by Centre Hospitalier Sud Francilien 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 4 inclusion and 2 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 Aug 2024. 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?
distribution of lower respiratory tract diseases (time frame: at day 0). 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 Aug 2024.