Esophageal AtresiaATRESIANCT05527873
Respiratory Complications of Operated Esophageal Atresia in Children
An observational study of Esophageal Atresia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The respiratory complications of esophageal atresia have already been identified. They are mainly related to tracheomalacia linked to the esophageal malformation, and are aggravated by frequently associated gastroesophageal reflux. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Esophageal Atresia
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2022to 16 Dec 2022
- 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 year to 12 years
- All sexes
- Child
Study population: Child aged 1 to 12 years old operated on for esophageal atresia and followed up at the University Hospitals of Strasbourg
Who may be able to join
- Child aged 1 to 12 years old
- Child operated on for esophageal atresia between 01/01/2010 and 31/12/2020 and followed up at the University Hospitals of Strasbourg
- Child who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research
- Parental authority having not expressed, after being informed, their opposition to the reuse of their child's data for the purposes of this research.
Who cannot join
- Subject and/or parental authority having expressed their opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France
Strasbourg, 67091
About this study
The respiratory complications of esophageal atresia have already been identified.
They are mainly related to tracheomalacia linked to the esophageal malformation, and are aggravated by frequently associated gastroesophageal reflux.
Read more
In this context, symptoms of asthma (or bronchial hyperreactivity) occur more frequently than in the general population and persist into adulthood. Their pathogenesis is still poorly understood and is the subject of much discussion.
The therapeutic management of these respiratory complications, poorly codified, remains very heterogeneous from one center to another. In France, the summary of knowledge is updated by the Reference Center for chronic and malformative diseases of the esophagus.
- Conditions
- Esophageal Atresia
- Keywords
- esophageal atresia, esophageal malformation, gastroesophageal reflux, asthma, bronchial hyperreactivity
- Medical subject headings
- Esophageal Atresia, Gastroesophageal Reflux, Asthma, Bronchial Hyperreactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of respiratory complications of esophageal atresia in children
Measured: Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start16 Mar 2022
- Primary completion16 Oct 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence WEISS, MD, Principal investigator, Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527873
- Sponsor's protocol ID
- 8562
- Acronym
- ATRESIA
- Status last verified
- Nov 2023
- First submitted
- 1 Sep 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Complications of Operated Esophageal Atresia in Children
- ClinicalTrials.gov ID
- NCT05527873
- Acronym / sponsor ID
- ATRESIA / 8562
- Conditions
- Esophageal Atresia
- Keywords
- esophageal atresia, esophageal malformation, gastroesophageal reflux, asthma, bronchial hyperreactivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 16 Oct 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 6 Sep 2022 (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 respiratory complications of esophageal atresia have already been identified.
They are mainly related to tracheomalacia linked to the esophageal malformation, and are aggravated by frequently associated gastroesophageal reflux.
In this context, symptoms of asthma (or bronchial hyperreactivity) occur more frequently than in the general population and persist into adulthood. Their pathogenesis is still poorly understood and is the subject of much discussion.
The therapeutic management of these respiratory complications, poorly codified, remains very heterogeneous from one center to another. In France, the summary of knowledge is updated by the Reference Center for chronic and malformative diseases of the esophagus.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Child aged 1 to 12 years old operated on for esophageal atresia and followed up at the University Hospitals of Strasbourg
Key inclusion criteria (4 listed)
- Child aged 1 to 12 years old
- Child operated on for esophageal atresia between 01/01/2010 and 31/12/2020 and followed up at the University Hospitals of Strasbourg
- Child who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research
- Parental authority having not expressed, after being informed, their opposition to the reuse of their child's data for the purposes of this research.
Key exclusion criteria (1 listed)
- Subject and/or parental authority having expressed their opposition to participating in the study
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
Retrospective study of respiratory complications of esophageal atresia in children
Time frame: Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined
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 8 Nov 2023.
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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.
Laurence WEISS, MD principal investigator
Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France
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 Esophageal Atresia, run by University Hospital, Strasbourg, France 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 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 8 Nov 2023. 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?
Retrospective study of respiratory complications of esophageal atresia in children (time frame: Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined). 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 8 Nov 2023.