Epidemiology of Pediatric Traumatology | NCT05625165

Studies
Epidemiology of Pediatric Traumatology

NCT05625165

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Nov 2, 2023Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Fractures in Children

Interventions

Not provided

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2, 2020Actual

Primary Completion Date

Aug 2, 2021Actual

Completion Date

Oct 2, 2021Actual

First Submitted Date

Nov 14, 2022

First Submission Date that Met QC Criteria

Nov 14, 2022

First Posted Date

Nov 22, 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

Oct 30, 2023

Last Update Posted Date

Nov 2, 2023Actual

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

Fractures have been shown to account for 10-25% of injuries in children and the consequences of pediatric fractures are significant and result in significant restriction of activity. Despite this, the epidemiology of pediatric fractures remains poorly detailed.

Investigators seek to establish the incidence of pediatric trauma and fractures and determine patient, trauma and injury characteristics.

Detailed Description

Not provided

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

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of pediatric trauma and fractures and to determine the characteristics of patients, traumas and lesions	This study focuses on retrospective analysis of patients' medical records	Files analysed retrospectively from January 01, 2014 to December 31, 2012 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Children treated in the pediatric emergency department of the Strasbourg University Hospitals between January 2014 and December 2020 for skeletal trauma.
Child and Holders of parental authority who have been informed of the use of their child's data for the purposes of this research and who have not expressed any opposition

Exclusion criteria:

Patient or legal representative who expressed their opposition to participating in the study
Impossibility of giving informed information to the subject

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

17 Years

Standard Ages

Child

Study Population

Children treated in the pediatric emergency department of the Strasbourg University Hospitals between January 2014 and December 2020 for skeletal trauma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France		Strasbourg		67091	France