- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05168540
Frequency, Consequences, and Determinants of Suboptimal Care in the Initial Care Pathway of Child Physical Abuse (DIAPED)
August 25, 2025 updated by: Nantes University Hospital
Frequency, Consequences, and Determinants of Suboptimal Care in the Initial Care Pathway of Child Physical Abuse: a Confidential Prospective Population-based Study in the French Western Region
Physical abuse is a significant cause of morbidity and mortality in the general child population.
There are no data specific to the French child care and protection systems, and very few studies have examined the optimality of protective measures following a diagnosis of child physical abuse.
the investigators propose to conduct a confidential, prospective, population-based study, in order to assess the frequency of suboptimal care, to describe the typology of suboptimal care, to assess the immediate consequences of suboptimal care on the health of the child, and to identify the determinants of suboptimal care.
Study Overview
Detailed Description
Each year, 4 to 16% of minors are reported to be physically abused in high-incomes countries.
Physical abuse is a significant cause of morbidity and mortality in the general child population.
American and Canadian studies have shown that the diagnosis of child physical abuse is often delayed, putting children at risk of recurrence of abuse before diagnosis.
There are no data specific to the French child care and protection systems, and very few studies have examined the optimality of protective measures following a diagnosis of child physical abuse.
A better understanding of the typology of suboptimal care, its consequences and its determinants would allow to propose targeted action plans to optimize the care pathway and thus reduce the risk of recurrence and morbimortality.
the investigators therefore propose to conduct a confidential, prospective, population-based study with an expert committee in the jurisdiction of the Court of Appeal of Rennes, in order to assess the frequency of suboptimal care, to describe the typology of suboptimal care, to assess the immediate consequences of suboptimal care on the health of the child, and to identify the determinants of suboptimal care.
This study will allow a multidisciplinary work (medical, social, educational and legal) around child physical abuse in order to set up, in a second time, interventional trials to reduce these delays and to build the first French regional registry of child physical abuse.
Study Type
Observational
Enrollment (Actual)
250
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
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Nantes, France
- CHU de Nantes
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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 6 years (Child)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Children under the age of six who are suspected victims of physical abuse that led to an alert from authorities.
Description
Inclusion Criteria:
- Children under the age of six who are suspected victims of physical abuse that led to an alert from authorities: traumatic skin or mucosal injury, (burn, bruise, hematoma, wound, conjunctival hemorrhages), intraocular hemorrhages, hemotympanum, traumatic looking intracranial injury, fracture, traumatic intra-abdominal or intra-thoracic injury to hollow or solid organs, non-accidental drug intoxication. For feasibility reasons, children will be included on the occasion of an admission to pediatric unit, the emergency room, the intensive care unit or a consultation in a specialized unit for children at risk of abuse. Their primary care pathway will be analyzed. Children who died in pre-hospital care in a context of strongly suspected maltreatment will also be included.
Non-inclusion Criteria:
- Emotional abuse, sexual abuse or neglect, without apparent physical harm.
- Children who have not been the subject of an administrative or judicial report by the hospital team taking care of the child.
Exclusion Criteria:
Child with a traumatic injury without suspicion of abuse.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Frequency in percentage of suboptimal care pathways
Time Frame: 2 years
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The optimality of the care will be evaluated by 2 independent experts and blinded to the final diagnosis (abuse confirmed or not) and to the child's health outcome
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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- Main typologies of suboptimal care
Time Frame: 2 years
|
the failures identified in the care pathway will be classified according to a grid and analyzed by experts.
experts will classify the care pathway as optimal, suboptimal possible or suboptimal certain
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2 years
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Determinants of suboptimal care
Time Frame: 2 years
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The expertise will classify the children's care pathway as: optimal, suboptimal certain and suboptimal possible.
The study of the determinants of suboptimal care will be carried out by comparing the characteristics of the children, their injuries and the actors involved in their care in each of the 3 groups
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2 years
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Potential consequences of suboptimal care in death
Time Frame: 12 months
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Analysis of the consequences of suboptimality in the care pathway will be done by comparing the number of dead patients with suboptimal care pathway, those surviving with sequelae and those surviving without sequelae at ICU discharge and at 12 months.
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12 months
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Potential consequences of suboptimal care in hospitalization
Time Frame: 2 years
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Analysis of the consequences of suboptimality in the care pathway will be done by comparing the number of patients hospitalized with suboptimal care pathway versus non-hospitalized patients, adjusting for the same variables as for survival
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2 years
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Potential consequences of suboptimal care on recurrency of child abuse
Time Frame: 1 years
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Analysis of the consequences of suboptimality in the care pathway will be done by comparing the number of patients with suboptimal care pathway with recurrences of child abuse or hospitalizations at one year to those without recurrences or hospitalizations at one year.
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1 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 1, 2021
Primary Completion (Actual)
August 20, 2025
Study Completion (Actual)
August 20, 2025
Study Registration Dates
First Submitted
September 2, 2021
First Submitted That Met QC Criteria
December 8, 2021
First Posted (Actual)
December 23, 2021
Study Record Updates
Last Update Posted (Estimated)
August 26, 2025
Last Update Submitted That Met QC Criteria
August 25, 2025
Last Verified
August 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- RC20_0092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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