NCT06867770

Proportion of Complications in Infants with an Isolated Skull Fracture Following Mild TC.

Completed Last updated 10 March 2025

What this trial tests

trial testing Observe the frequency of clinical or paraclinical complications during the hospitalization of these children. in Pediatric Head Trauma in 100 participants. Completed in 31 December 2022.

Timeline

1 June 2022

Primary endpoint
30 September 2022

31 December 2022

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	1 June 2022
Primary completion	30 September 2022
Estimated completion	31 December 2022
Sites	1 location across France

Drugs / interventions tested

• Observe the frequency of clinical or paraclinical complications during the hospitalization of these children.

Conditions studied

• Pediatric Head Trauma — all drugs for Pediatric Head Trauma →
• Isolated Skull Fracture — all drugs for Isolated Skull Fracture →
• Pediatric — all drugs for Pediatric →
• Head Trauma Injury — all drugs for Head Trauma Injury →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Under 24 Months, any sex, with Pediatric Head Trauma or Isolated Skull Fracture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.