NCT04371484

Brief Summary

The epidemiological data currently available on child abuse in France are very inadequate. They do not make it possible to know the number of child victims, nor the precise context and impact of this violence. Very often, the figures put forward are underestimated. Improving the knowledge of these situations would make it possible to develop targeted primary and secondary prevention programs. In this study, is proposed an innovative method of exploiting existing national databases, the PMSI and SNIIRAM, with the aim of 1) approaching an order of magnitude of the frequency of physical abuse in children and 2) evaluating its contexts and consequences. The PMSI is a high-quality database that has been used for many years for medical research purposes. It provides a large amount of epidemiological information and can be used to create cohorts large enough to detect rare events. The SNIIRAM/EGB data allows the recovery of all data on reimbursed consumption, such as drug treatments, biological examinations carried out or consultations (with general practitioners or specialists).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,002,359

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

April 29, 2020

Last Update Submit

March 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of confirmed diagnoses for child abuse

    Through study completion, an average of 2 years

Study Arms (1)

children from 0 to 5 years old, hospitalized

Other: ICD-10

Interventions

ICD-10OTHER

A collection of ICD-10 codes used within the PMSI that relate to physical abuse.

children from 0 to 5 years old, hospitalized

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children hospitalized in France between 2007 and 2014

You may qualify if:

  • All children aged 0 to 5 years hospitalized in France between 2007 and 2014.
  • Based on ICD-10 codes generated within the PMSI, 3 groups of children were defined:
  • those with at least one code dedicated to physical abuse,
  • those with at least one code or "combination of codes" suspected of physical abuse, and
  • all other hospitalized children, control group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Related Publications (1)

  • ESTIMATION DE LA PRÉVALENCE DES ENFANTS DE MOINS D'UN AN, HOSPITALISÉS EN FRANCE POUR MALTRAITANCE PHYSIQUE SUR LA PÉRIODE 2007-2014 Séverine Gilard-Pioc1, Jonathan Cottenet2,3, Irène François-Purssell1, Catherine Quantin2,3,4 BEH 26-27 | 15 octobre 2019

    RESULT

Study Design

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

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 1, 2020

Study Start

May 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations