Information Remembered by Parents Following the Ingestion of Foreign Body by Their ChildMICENCT05652166
What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child?
An observational study of Information Remembered by Parents Following the Ingestion of Foreign Body by Their Child, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Information Remembered by Parents Following the Ingestion of Foreign Body by Their Child
- What is being tested?
- telephone interview
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2022to 1 May 2023
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children consulting at Robert Debre Hospital following the ingestion of foreign body
Who may be able to join
- Children under 18 years
- Foreign body ingestion
Who cannot join
- Refusal to participate in the study
- Non-French speaking parents
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Robert Debre Hospital
Paris, 75019
Jérôme VIALA, MD, PhD, +3340030000, jerome.viala@aphp.fr
Naim DRID, MD, +3340030000, naim.drid@aphp.fr
About this study
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.
Read the 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.
- Being tested
- telephone interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone interviewOther
telephone call to parents to know the information given following the ingestion of foreign body by their child
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the instructions memorized by the parents after a visit to the hospital for a foreign body ingestion by their child.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 May 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Information Remembered by Parents Following the Ingestion of Foreign Body by Their ChildStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme VIALA, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652166
- Sponsor's protocol ID
- APHP-MICE
- Acronym
- MICE
- Status last verified
- Nov 2022
- First submitted
- 7 Dec 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child?
- ClinicalTrials.gov ID
- NCT05652166
- Acronym / sponsor ID
- MICE / APHP-MICE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 15 Dec 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children consulting at Robert Debre Hospital following the ingestion of foreign body
Key inclusion criteria (2 listed)
- Children under 18 years
- Foreign body ingestion
Key exclusion criteria (2 listed)
- Refusal to participate in the study
- Non-French speaking parents
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 |
|---|---|---|
| telephone interviewtelephone call to parents to know the information given following the ingestion of foreign body by their child | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: Undecided
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.
Jérôme VIALA, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Information Remembered by Parents Following the Ingestion of Foreign Body by Their Child, run by Assistance Publique - Hôpitaux de Paris 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 2 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: status not confirmed, as of the sponsor's last update on 15 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérôme VIALA, MD, PhD (+33140030000, jerome.viala@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.