Clinical trial NCT06867770: Proportion of Complications in Infants with an Isolated Skull Fracture Following Mild TC.
Official title: What is the Proportion of Complications Observed in Infants ≤ 24 Months with a Mild TC (Glasgow ≥ 13) with an Isolated Skull Fracture on the CT Scan (carried Out from H4 of the TC) and Hospitalized At the HFME from 2017 to 2021
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Head Trauma
Isolated Skull Fracture
Pediatric
Head Trauma Injury
Keywords: infants
Head trauma
isolated skull fracture
pediatric
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 100
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be taken from children who came to the pediatric emergency room of HFME for a head trauma from January 1, 2017 to December 31, 2021. \*

Brief summary: Childhood head trauma (TC) is a frequent reason for emergency visits. A bibliographic summary published by Santé Publique France reveals an annual incidence of CD among 0-4 year olds estimated at around 1,340 cases per 100,000 inhabitants in the United States, of which 11% would be intentional (i.e. linked to abuse).

The child presents specificities due to the characteristics of his development, such as :

* the weight of his head, in proportion to his body, is more important compared to the adult;
* the brain is richer in water;
* the bones of the skull are more mouldable and elastic. For these reasons, CD in children has very different consequences from adults, hence the need for a good knowledge of the subject for prevention, management and optimal monitoring of CD in children.

Within the Hospital Femme Mère Enfant (HFME), the procedure consists in hospitalizing all the children presenting a fracture of the skull. They systematically benefit from clinical monitoring, fundoscopy, an electroencephalogram (EEG) and a 3-month consultation with a neurosurgeon to eliminate any complications, but also to detect the inflicted head trauma.

This treatment entails hospitalization for several days for the child and the parents.

The question of the invariability of this local protocol arises because it entails:

* for the parents, linked to the meaning they give to hospitalization
* carrying out several additional examinations for the infant
* a duration of hospitalization which can be extended while waiting for the availability of para-clinical examinations.

Today, HFME specialists intuitively feel that the complication rate is low. In the literature, there are several articles relating the evolution of these children with an isolated fracture of the skull. A review of the literature shows that only 8 out of 5,000 patients had an aggravation of their scanner (such as the appearance of haemorrhage) and none were operated on. Other studies tend to show the absence of deaths, a very low rate of surgery or neurological deficit. There is a suspicion of abuse in 1 to 20% of cases.

Some studies go even further by proposing and evaluating service protocols allowing simple monitoring in the emergency room, then a return home for children with a skull fracture without intracranial lesion and a Glasgow score ≥ 14. These latest studies therefore put general practitioners and paediatricians back in the front line for the follow-up, even in the short term, of infants with an isolated skull fracture.

This study would make it possible to quantify the complications of mild head trauma (Glasgow 13-15) with isolated skull fracture in infants hospitalized in the HFME, and this with unpublished data (electroencephalogram and fundoscopy). According to the results obtained, this could lead to the modification of the care of infants by proposing a reduction in additional examinations and hospitalization, by introducing outpatient monitoring, and this without putting the infant in danger or neglecting inflicted head truama.


Eligibility criteria: * Inclusion Criteria \* :

  * Infant 24 months or less
  * presenting to the pediatric emergencies of HFME
  * for mild head trauma, defined by a Glasgow score greater than or equal to 13,
  * having a scanner at least H4 from their TC
  * and having an isolated skull fracture
* Exclusion Criteria \* :

  * Birth-related trauma
  * history of neurosurgery
  * history of brain tumor
  * Polytrauma
  * Public road accident
  * Personal encephalopathy ATCD
  * Bleeding disorder
  * Anticoagulant treatment
  * Known epilepsy
  * Medium TC and Grace
  * Added presence of hemorrhage, edema or axonal lesion on the initial CT scan

Primary outcomes:
measure: frequency of clinical or paraclinical complications during the hospitalization of these children.
timeFrame: - During the hospitalisation - During the consultations organized 3 months after the head trauma.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Femme Mère Enfant
Study officials:
References: