- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04371484
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 (MENFIS)
May 4, 2020 updated by: Centre Hospitalier Universitaire Dijon
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).
Study Overview
Study Type
Observational
Enrollment (Actual)
4002359
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dijon, France, 21079
- CHU Dijon Bourgogne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
children hospitalized in France between 2007 and 2014
Description
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:
- 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.
Exclusion Criteria: NA
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
children from 0 to 5 years old, hospitalized
|
A collection of ICD-10 codes used within the PMSI that relate to physical abuse.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of confirmed diagnoses for child abuse
Time Frame: Through study completion, an average of 2 years
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
April 29, 2020
First Submitted That Met QC Criteria
April 30, 2020
First Posted (Actual)
May 1, 2020
Study Record Updates
Last Update Posted (Actual)
May 6, 2020
Last Update Submitted That Met QC Criteria
May 4, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- GILARD-PIOC AOI 2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child Abuse
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruiting
-
Oral Health Centre of Expertise in Western NorwayOral Health Center of Expertise Rogaland, Norway; Childrens advocacy center... and other collaboratorsRecruitingChild Abuse | Child Neglect | Child MaltreatmentNorway
-
Yeditepe UniversityRecruitingEducational Program's Impact on Nursing Students' Knowledge and Awareness of Child Abuse and NeglectChild Abuse | Child NeglectTurkey
-
Karolinska InstitutetActive, not recruitingChild Abuse | Child MaltreatmentSweden
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedChild Abuse | Child NeglectUnited States
-
Milton S. Hershey Medical CenterRecruitingChild Abuse | Child Neglect | Child MaltreatmentUnited States
-
University of ChicagoUniversity of California, Los Angeles; Oak Foundation; UBS Optimus Foundation; Trickle... and other collaboratorsCompletedChild Abuse | Child MaltreatmentBurkina Faso
-
University of PittsburghPatient-Centered Outcomes Research Institute; Northwell Health; University of...CompletedChild Abuse | Trauma | Child Maltreatment | Physical AbuseUnited States
-
McGill UniversitySave the Children; European Network of Foundations Children and Violence Evaluation... and other collaboratorsUnknown
-
Institute of Psychiatry, LondonBanaras Hindu University; Tribhuvan University, NepalCompletedChild Abuse | Child Neglect | VictimizationIndia, Nepal
Clinical Trials on ICD-10
-
Barts & The London NHS TrustCompletedHeart FailureUnited Kingdom
-
Wuerzburg University HospitalUniversity of Leipzig; University of Wuerzburg; Campus Bad Neustadt; Klinikum Aschaffenburg-Alzenau and other collaboratorsCompletedDepression | Quality of Life | AnxietyGermany
-
Boston Scientific CorporationCompletedTachycardia, VentricularUnited Kingdom, Denmark, Italy, New Zealand, Germany, France, Netherlands, Portugal, Czechia, Spain
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceRecruitingHeart Failure | Implantable Cardioverter Defibrillator | Primary Prevention of Sudden Cardiac DeathFrance
-
Biotronik SE & Co. KGCompletedHeart Failure | TachyarrhythmiaDenmark, France, Germany, Spain, Switzerland, Israel, Latvia, Australia, Singapore, Austria
-
Biotronik, Inc.CompletedPatients Indicated for an ICDUnited States
-
Medtronic Bakken Research CenterMedtronicCompletedTachycardia, VentricularGermany, Denmark
-
Unity Health TorontoApplied Health Research Centre; Biotronik Canada IncActive, not recruitingCardiovascular Diseases | Implantable Cardioverter-Defibrillators | Cardiac Arrhythmias | Atrial Fibrillation and FlutterCanada
-
Vanderbilt University Medical CenterThoratec CorporationCompleted
-
Boston Scientific CorporationCompletedVentricular Fibrillation | Ventricular TachycardiaUnited Kingdom