NCT05261074

Brief Summary

Ingestion of foreign bodies (FB) is one of the most observed domestic accidents and a frequent reason for consultation in pediatric emergency departments (PED). In the United States, nearly 100,000 ingestions of FB have been recorded by the National Poison Data System (NPDS), which represented the 4th cause of intoxication in 2015. Ingestion of FB involves very different mechanisms in children and adult patients. Unlike adults, 98% of FB ingestions in children are accidental and involve common objects found at home environment. Ingested FBs are of many types and vary depending on the object composition of the child's environment and supervision. The lockdown for COVID-19 pandemic highly modified children environment and parent supervision. Children remained at home and parents lived at home for teleworking. In this study, the modifications of children environment that could affect epidemiology of FB ingestion will be evaluated. This is a retrospective study with a sample of around \> 100 children of Louis Mourier hospital from January 1 to December 31, 2019 and from March 1 to May 31, 2020. The total duration of the study is planned for 10 months. Primary outcomes:

  • To determine the role of COVID-19 pandemic linked containment on the prevalence of FB ingestions in children. Secondary outcomes:
  • Describe the epidemiological-clinical, radiological, therapeutic and evolutionary characteristics of the FB consultant's ingestions in the emergency department
  • Determine the frequency of endoscopy or surgery
  • Determine the factors favoring the use of endoscopic extraction From March 16 to May 10, 2020.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

February 28, 2022

Last Update Submit

February 28, 2022

Conditions

Keywords

Foreign bodyChildrenCovid-19Oesophagus

Outcome Measures

Primary Outcomes (1)

  • Prevalence of foreign body (FB) ingestions in children

    To determine the role of COVID-19 pandemic linked containment on the prevalence of foreign body (FB) ingestions in children

    1 year

Interventions

No intervention (retrospective study)

Eligibility Criteria

Age1 Day - 15 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Child who consulted in the pediatric emergency department of Louis-Mourier University Hospital for ingestion of foreign bodies coded in Urqual software.

You may qualify if:

  • Children \<15 years old.
  • Child who consulted in the pediatric emergency department of Louis-Mourier University Hospital.
  • For ingestion of foreign bodies coded in Urqual software.

You may not qualify if:

  • Refusal to participate in the study
  • unusable files (\> 20% missing data out of a total of 40 major items),
  • Ingestion of CE was suspected but not confirmed,
  • Ingestion of caustics or other chemicals,
  • Introduced from an FB into the digestive tract by a route other than the oral cavity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Mourier Hospital - Assistance Publique Hopitaux de Paris

Colombes, 92025, France

RECRUITING

MeSH Terms

Conditions

Foreign BodiesCOVID-19

Condition Hierarchy (Ancestors)

Wounds and InjuriesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jerôme VIALA, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

Central Study Contacts

Jerôme VIALA, MD, PhD

CONTACT

Naim DRID, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 2, 2022

Study Start

October 20, 2021

Primary Completion

October 20, 2022

Study Completion

October 20, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations