NCT05652166

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

December 15, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

December 7, 2022

Last Update Submit

December 7, 2022

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Identify the instructions memorized by the parents after a visit to the hospital for a foreign body ingestion by their child.

    1 year

Interventions

telephone interviewOTHER

telephone call to parents to know the information given following the ingestion of foreign body by their child

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Children under 18 years
  • Foreign body ingestion

You may not qualify if:

  • Refusal to participate in the study
  • Non-French speaking parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

RECRUITING

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jérôme VIALA, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérôme VIALA, MD, PhD

CONTACT

+33140030000jerome.viala@aphp.fr

Naim DRID, MD

CONTACT

+33140030000naim.drid@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 15, 2022

Study Start

May 1, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

December 15, 2022

Record last verified: 2022-11

Locations

FR(1)