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NCT04371484 Clinical Trial

Proposal of a Method Using the PMSI and SNIIRAM National Databases to Estimate the Frequency of Physical Abuse and to Identify th Eassociated At-risk Situations and Consequences in Children Aged 0 to 5 Years in France

Child Abuse Clinical Trial

— MENFIS  

Official title:
Proposal of a Method Using the PMSI and SNIIRAM National Databases to Estimate the Frequency of Physical Abuse and to Identify th Eassociated At-risk Situations and Consequences in Children Aged 0 to 5 Years in France

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04371484
Other study ID # GILARD-PIOC AOI 2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2017
Est. completion date December 1, 2019

Study information
Verified date April 2020
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 4002359
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 5 Years
Eligibility Inclusion Criteria:

- 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:

1. those with at least one code dedicated to physical abuse,

2. those with at least one code or "combination of codes" suspected of physical abuse, and

3. all other hospitalized children, control group.

Exclusion Criteria: NA

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France CHU Dijon Bourgogne Dijon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of confirmed diagnoses for child abuse Through study completion, an average of 2 years
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