- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05652166
What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child? (MICE)
December 7, 2022 updated by: Assistance Publique - Hôpitaux de Paris
Foreign body (FB) ingestion is a very common domestic accident in children.
The prevention of the recurrence by securing child's environment is mandatory.
The study will study whether the advices of follow-up at home and recurrence prophylaxis were given to parents after a foreign ingestion by their child.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Foreign body ingestion (FB) is a very common domestic accident in children.
When the FB is not dangerous or it is inaccessible after crossing the pylorus, the child should be monitored.
In all cases, recurrence should be prevented by securing the environment of the swallowing child.
The information on monitoring and securing the environment should be communicated during hospital care.
This prospective study will analyze whether advices were correctly given to the families concerning the follow-up at home and the prophylaxis of FB ingestion.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jérôme VIALA, MD, PhD
- Phone Number: +33140030000
- Email: jerome.viala@aphp.fr
Study Contact Backup
- Name: Naim DRID, MD
- Phone Number: +33140030000
- Email: naim.drid@aphp.fr
Study Locations
-
-
-
Paris, France, 75019
- Recruiting
- Robert Debré Hospital
-
Contact:
- Jérôme VIALA, MD, PhD
- Phone Number: +3340030000
- Email: jerome.viala@aphp.fr
-
Contact:
- Naim DRID, MD
- Phone Number: +3340030000
- Email: naim.drid@aphp.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 14 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children consulting at Robert Debre Hospital following the ingestion of foreign body
Description
Inclusion Criteria:
- Children under 18 years
- Foreign body ingestion
Exclusion Criteria:
- Refusal to participate in the study
- Non-French speaking parents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Identify the instructions memorized by the parents after a visit to the hospital for a foreign body ingestion by their child.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jérôme VIALA, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Anticipated)
May 1, 2023
Study Completion (Anticipated)
May 1, 2023
Study Registration Dates
First Submitted
December 7, 2022
First Submitted That Met QC Criteria
December 7, 2022
First Posted (Estimate)
December 15, 2022
Study Record Updates
Last Update Posted (Estimate)
December 15, 2022
Last Update Submitted That Met QC Criteria
December 7, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP-MICE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on telephone interview
-
Dongzhimen Hospital, BeijingUnknown
-
University of California, IrvineNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Centre Hospitalier Universitaire de Saint EtienneNot yet recruitingGeriatric | Care Coordination | Readmission, HospitalFrance
-
Centre Hospitalier le MansUnknownOsteoporosis | Osteoporotic FracturesFrance
-
Hillel Yaffe Medical CenterUnknown
-
Papworth Hospital NHS Foundation TrustUnknown
-
University Hospital, BordeauxActive, not recruitingStroke | Stroke SequelaeFrance
-
Fundación Pública Andaluza para la Investigación...UnknownDementia | Mild Cognitive ImpairmentSpain
-
University Hospital, AngersCompleted
-
Rennes University HospitalCompletedArteriovenous MalformationsFrance