NCT05168540

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2024

Enrollment Period

3.9 years

First QC Date

September 2, 2021

Last Update Submit

August 25, 2025

Conditions

Keywords

Child physical abusesuboptimalitycare pathwaypopulation-based study

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (5)

  • - Main typologies of suboptimal care

    2 years

  • Determinants of suboptimal care

    2 years

  • Potential consequences of suboptimal care in death

    12 months

  • Potential consequences of suboptimal care in hospitalization

    2 years

  • Potential consequences of suboptimal care on recurrency of child abuse

    1 years

Interventions

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.

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children under the age of six who are suspected victims of physical abuse that led to an alert from authorities.

You may qualify if:

  • 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.

You may not qualify if:

  • Child with a traumatic injury without suspicion of abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2021

First Posted

December 23, 2021

Study Start

October 1, 2021

Primary Completion

August 20, 2025

Study Completion

August 20, 2025

Last Updated

August 26, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations