Pediatric Head TraumaNCT06867770
Proportion of Complications in Infants with an Isolated Skull Fracture Following Mild TC.
An observational study of Pediatric Head Trauma and Isolated Skull Fracture, run by Hospices Civils de Lyon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Pediatric Head Trauma, Isolated Skull Fracture, Pediatric
- What is being tested?
- Observe the frequency of clinical or paraclinical complications during the hospitalization of these children.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 31 Dec 2022
- 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 24 months
- All sexes
- No healthy volunteers
- Child
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. *
Who may be able to join
- 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
Who cannot join
- Birth-related trauma
- history of neurosurgery
- history of brain tumor
- Polytrauma
- Public road accident
- Personal encephalopathy ATCD
Show all 11Show fewer
- Bleeding disorder
- Anticoagulant treatment
- Known epilepsy
- Medium TC and Grace
- Added presence of hemorrhage, edema or axonal lesion on the initial CT scan
Trial locations and contacts
1 site in 1 country.
About this study
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
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 :
Read more
- 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.
- Being tested
- Observe the frequency of clinical or paraclinical complications during the hospitalization of these children.
- Keywords
- infants, Head trauma, isolated skull fracture, pediatric
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observe the frequency of clinical or paraclinical complications during the hospitalization of these children.Behavioural
The goal is to collect data on the files of infants hospitalized at the HFME from 2017 to 2021 for monitoring a isolated skull. The data that will be collected are an integral part of the child's care and pre-exist the study. This data will be anonymized and no interaction with the patient is envisaged.
| Study group | Role | What they receive |
|---|---|---|
| Infants aged 24 months or less coming to the emergency department with the discovery of an isolated | * 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 Receives: Behavioral: Observe the frequency of clinical or paraclinical complications during the hospitalization of these children. |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of clinical or paraclinical complications during the hospitalization of these children.
- Death
- Need for surgery
- - Change in the patient's neurological state: decrease in Glasgow score, convulsion, neurological deficit
Measured: - During the hospitalisation - During the consultations organized 3 months after the head trauma.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Jun 2022
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Head TraumaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867770
- Sponsor's protocol ID
- 878
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06867770
- Acronym / sponsor ID
- 878
- Keywords
- infants, Head trauma, isolated skull fracture, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Mar 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants aged 24 months or less coming to the emergency department with the discovery of an isolated | – | Behavioral: Observe the frequency of clinical or paraclinical complications during the hospitalization of these children.* 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 |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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. *
Key inclusion criteria (5 listed)
Key exclusion criteria (11 listed)
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 |
|---|---|---|
| Observe the frequency of clinical or paraclinical complications during the hospitalization of these children.The goal is to collect data on the files of infants hospitalized at the HFME from 2017 to 2021 for monitoring a isolated skull. The data that will be collected are an integral part of the child's care and pre-exist the study. This data will be anonymized and no interaction with the patient is envisaged. | Behavioural | Infants aged 24 months or less coming to the emergency department with the discovery of an isolated |
Primary outcome
frequency of clinical or paraclinical complications during the hospitalization of these children.
Time frame: - During the hospitalisation - During the consultations organized 3 months after the head trauma.
* Death * Need for surgery * - Change in the patient's neurological state: decrease in Glasgow score, convulsion, neurological deficit
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 10 Mar 2025.
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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 Pediatric Head Trauma and Isolated Skull Fracture, run by Hospices Civils de Lyon 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 5 inclusion and 11 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 10 Mar 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 of clinical or paraclinical complications during the hospitalization of these children. (time frame: - During the hospitalisation - During the consultations organized 3 months after the head trauma.). 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 10 Mar 2025.