What Information is Remembered by Parents Following the I... | NCT05652166

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

NCT05652166

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Dec 15, 2022Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Information Remembered by Parents Following the Ingestion of Foreign Body by Their Child

Interventions

telephone interview

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

May 1, 2023Estimated

Completion Date

May 1, 2023Estimated

First Submitted Date

Dec 7, 2022

First Submission Date that Met QC Criteria

Dec 7, 2022

First Posted Date

Dec 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2022

Last Update Posted Date

Dec 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
telephone interview	Other	telephone call to parents to know the information given following the ingestion of foreign body by their child

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identify the instructions memorized by the parents after a visit to the hospital for a foreign body ingestion by their child.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children under 18 years
Foreign body ingestion

Exclusion Criteria:

Refusal to participate in the study
Non-French speaking parents

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children consulting at Robert Debre Hospital following the ingestion of foreign body

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jérôme VIALA, MD, PhD	Contact	+33140030000		jerome.viala@aphp.fr
Naim DRID, MD	Contact	+33140030000		naim.drid@aphp.fr

Overall Officials

Name	Affiliation	Role
Jérôme VIALA, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Robert Debre Hospital	Recruiting	Paris		75019	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007407	Interviews as Topic

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided