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NCT Number: NCT05168540

Frequency, Consequences, and Determinants of Suboptimal Care in the Initial Care Pathway of Child Physical Abuse

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.

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Key information

Conditions

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. - 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

  2. Determinants of suboptimal care

    Time frame: 2 years

    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

  3. Potential consequences of suboptimal care in death

    Time frame: 12 months

    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.

  4. Potential consequences of suboptimal care in hospitalization

    Time frame: 2 years

    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

  5. Potential consequences of suboptimal care on recurrency of child abuse

    Time frame: 1 years

    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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: DIAPED

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2021
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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