Physical AbuseDIAPEDNCT05168540
Frequency, Consequences, and Determinants of Suboptimal Care in the Initial Care Pathway of Child Physical Abuse
An observational study of Physical Abuse, run by Nantes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Physical Abuse
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2021to 20 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under the age of six who are suspected victims of physical abuse that led to an alert from authorities.
Who may be able to join
- 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.
Who cannot join
- Child with a traumatic injury without suspicion of abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Abuse
- Being tested
- no intervention
- Keywords
- Child physical abuse, suboptimality, care pathway, population-based study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency in percentage of suboptimal care pathways
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
Measured: 2 years
Secondary outcomes (5)
- Main typologies of suboptimal care
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
Measured: 2 years
Determinants of suboptimal care
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
Measured: 2 years
Potential consequences of suboptimal care in death
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.
Measured: 12 months
Potential consequences of suboptimal care in hospitalization
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
Measured: 2 years
Potential consequences of suboptimal care on recurrency of child abuse
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.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Oct 2021
- Primary completion20 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical AbuseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168540
- Sponsor's protocol ID
- RC20_0092
- Acronym
- DIAPED
- Status last verified
- Aug 2024
- First submitted
- 2 Sep 2021
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05168540
- Acronym / sponsor ID
- DIAPED / RC20_0092
- Conditions
- Physical Abuse
- Keywords
- Child physical abuse, suboptimality, care pathway, population-based study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under the age of six who are suspected victims of physical abuse that led to an alert from authorities.
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- Child with a traumatic injury without suspicion of abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionChildren 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. | Other | – |
Primary outcome
Frequency in percentage of suboptimal care pathways
Time frame: 2 years
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
5 secondary outcomes
- Main typologies of suboptimal care
Time frame: 2 years
Determinants of suboptimal care
Time frame: 2 years
Potential consequences of suboptimal care in death
Time frame: 12 months
Potential consequences of suboptimal care in hospitalization
Time frame: 2 years
Potential consequences of suboptimal care on recurrency of child abuse
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Abuse, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency in percentage of suboptimal care pathways (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.