MICE: What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child?

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05652166
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Information Remembered by Parents Following the Ingestion of Foreign Body by Their Child	Other: telephone interview

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

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child?
• Actual Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Outcome Measures

Primary Outcome Measures

1. Identify the instructions memorized by the parents after a visit to the hospital for a foreign body ingestion by their child. [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children under 18 years

• Foreign body ingestion

Exclusion Criteria:

• Refusal to participate in the study

• Non-French speaking parents

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert Debre Hospital	Paris		France	75019

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Jérôme VIALA, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT05652166
• Other Study ID Numbers: APHP-MICE
• First Posted: Dec 15, 2022
• Last Update Posted: Dec 15, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Foreign Bodies

Study Results

No Results Posted as of Dec 15, 2022