Shaken Baby SyndromeFPASSBSNCT04105673
Predictors of Sequelae Appearance in Shaken Baby Syndrome
An observational study of Shaken Baby Syndrome, run by University Hospital, Tours.
Trial summary
This is an observational, prognostic and prospective study. It is about the Prognostic Factors for sequelae in children with a history of Shaken Baby Syndrome (SBS) in the Central region in France. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Shaken Baby Syndrome
- What is being tested?
- Clinical examination and survey
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2019to 28 Jun 2019
- 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 5 to 8 years
- All sexes
- Child
Study population: Children concerned had been admitted to hospital for Shaken Baby Syndrome before one year old in France, in the Central region
Who may be able to join
- Children must be between five and eight years old
- Hospitalization before one year old for a Shaken Baby Syndrome in the Center Region in France
Who cannot join
- Opposition of the legal representative to use the data
About this study
Official title: Prognostic Factors for Sequelae in Children With a History of Shaken Baby Syndrome in the Central Region
This is an observational, prognostic and prospective study. It is about the Prognostic Factors for sequelae in children with a history of Shaken Baby Syndrome (SBS) in the Central region in France. The study hypothesis is the prognosis of the sequelae children develop according to the severity criteria presents in admission to the hospital for the Shaken Baby Syndrome. The severity criteria are clinical high intracranial pressure, presence of a coma, vitreous hemorrhage, an age under 6 months, other cerebral lesion than subdural hematoma (parenchymal lesion, ischemia or cerebral oedema). Children affected by the nonaccidental head injury are today between five and eight years old.
Read the detailed description
Abusive head trauma is a severe inflicted traumatic brain injury, occuring under the age of 1 year, defined by an acute brain injury (mostly subdural or subarachnoidal haemorrhage), where no history or no compatible history with the clinical presentation is given.
This is secondary to violent shaking, with or without impact, of an infant by an adult, sufficient to cause brain injury. The mortality rate is estimated at 20-25% and growth of child is extremely poor. High rates of impairment are reported : motor deficit (spastic hemiplegia or quadriplegia), epilepsy often intractable, microcephaly with corticosubcortical atrophy, visual impairment even the blindness, language disorders, cognitive (intellectual deficit), behavioral (agitation, aggression, attention deficit, inhibition deficit) and sleep disorders. Several studies on the subject highlighted that an initial severe presentation is associated with worse growth.
These is very limited research on the outcome of inflicted traumatic brain injury and the results are heterogeneous. The study hypothesis is the prognosis of the sequelae children develop according to the severity criteria presented in admission to the hospital for the Shaken Baby Syndrome.
This is an epidemiological, observational, prognostic and prospective study. The severity criteria are clinical high intracranial pressure, presence of a coma, vitreous haemorrhage, an age under 6 months, other injuries than subdural hematoma (parenchymal injuries, ischemia or cerebral oedema).
The severity criteria were chosen by studying others studies on the subject. Children concerned had been admitted to hospital for Shaken Baby Syndrome between 2010 and 2014 in France, in the Central Region. Thus today, they are between five and eight years old. We know that sequelae occur after latency, in particular when children learn to read and write.
Primary purpose is to evaluate prognostic factors to develop sequelae after an inflicted traumatic brain injury as the shaken baby syndrome.
- Conditions
- Shaken Baby Syndrome
- Being tested
- Clinical examination and survey
- Keywords
- Shaken Baby Syndrome, long-term outcome, severity criteria in the admission to hospital for a Shaken Baby Syndrome, sequelae, brain injury, abusive head trauma
- Medical subject headings
- Shaken Baby Syndrome, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examination and surveyOther
Children will be seen during an one consultation. A clinical examination and survey are realized.
| Study group | Role | What they receive |
|---|---|---|
| Shaken Baby Syndrome | Realization of a clinical examination and survey on children with a past history of a Shaken Baby Syndrome Receives: Other: Clinical examination and survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
the sequelae motor developed by children with a past history of a Shaken Baby Syndrome.
The motor function is assessed by clinical neurological examination.
Measured: At the inclusion (Day 1)
the cognitive sequelae developed by children with a past history of a Shaken Baby Syndrome
The cognitive function is assessed by the Wechler Scale (WPPSI IV). This scale assesses the verbal understanding, spatial visual understanding, fluid reasoning, work memory and treatment speed.
Measured: At the inclusion (Day 1)
the behavioral sequelae developed by children with a past history of a Shaken Baby Syndrome.
Adaptive behavior is measured using the Vineland Adaptive Behavior Scales. This scale assesses 4 fields : communication, autonomy, socialization and motor function
Measured: At the inclusion (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start28 Jun 2019
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Why it stopped: CPP requalification
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shaken Baby SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline Saint Martin, MD-PhD, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105673
- Sponsor's protocol ID
- RIPH3-RNI18/FPASSBS
- Other IDs
- 2018-A03098-47
- Acronym
- FPASSBS
- Status last verified
- Sep 2019
- First submitted
- 11 Jan 2019
- Last updated
- 26 Sep 2019
- 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 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors for Sequelae in Children With a History of Shaken Baby Syndrome in the Central Region
- ClinicalTrials.gov ID
- NCT04105673
- Acronym / sponsor ID
- FPASSBS / RIPH3-RNI18/FPASSBS
- Conditions
- Shaken Baby Syndrome
- Keywords
- Shaken Baby Syndrome, long-term outcome, severity criteria in the admission to hospital for a Shaken Baby Syndrome, sequelae, brain injury, abusive head trauma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: CPP requalification
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 26 Sep 2019 (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.
This is an observational, prognostic and prospective study. It is about the Prognostic Factors for sequelae in children with a history of Shaken Baby Syndrome (SBS) in the Central region in France. The study hypothesis is the prognosis of the sequelae children develop according to the severity criteria presents in admission to the hospital for the Shaken Baby Syndrome. The severity criteria are clinical high intracranial pressure, presence of a coma, vitreous hemorrhage, an age under 6 months, other cerebral lesion than subdural hematoma (parenchymal lesion, ischemia or cerebral oedema). Children affected by the nonaccidental head injury are today between five and eight years old.
Detailed description
Abusive head trauma is a severe inflicted traumatic brain injury, occuring under the age of 1 year, defined by an acute brain injury (mostly subdural or subarachnoidal haemorrhage), where no history or no compatible history with the clinical presentation is given.
This is secondary to violent shaking, with or without impact, of an infant by an adult, sufficient to cause brain injury. The mortality rate is estimated at 20-25% and growth of child is extremely poor. High rates of impairment are reported : motor deficit (spastic hemiplegia or quadriplegia), epilepsy often intractable, microcephaly with corticosubcortical atrophy, visual impairment even the blindness, language disorders, cognitive (intellectual deficit), behavioral (agitation, aggression, attention deficit, inhibition deficit) and sleep disorders. Several studies on the subject highlighted that an initial severe presentation is associated with worse growth.
These is very limited research on the outcome of inflicted traumatic brain injury and the results are heterogeneous. The study hypothesis is the prognosis of the sequelae children develop according to the severity criteria presented in admission to the hospital for the Shaken Baby Syndrome.
This is an epidemiological, observational, prognostic and prospective study. The severity criteria are clinical high intracranial pressure, presence of a coma, vitreous haemorrhage, an age under 6 months, other injuries than subdural hematoma (parenchymal injuries, ischemia or cerebral oedema).
The severity criteria were chosen by studying others studies on the subject. Children concerned had been admitted to hospital for Shaken Baby Syndrome between 2010 and 2014 in France, in the Central Region. Thus today, they are between five and eight years old. We know that sequelae occur after latency, in particular when children learn to read and write.
Primary purpose is to evaluate prognostic factors to develop sequelae after an inflicted traumatic brain injury as the shaken baby syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shaken Baby Syndrome | – | Other: Clinical examination and surveyRealization of a clinical examination and survey on children with a past history of a Shaken Baby Syndrome |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- Children concerned had been admitted to hospital for Shaken Baby Syndrome before one year old in France, in the Central region
Key inclusion criteria (2 listed)
- Children must be between five and eight years old
- Hospitalization before one year old for a Shaken Baby Syndrome in the Center Region in France
Key exclusion criteria (1 listed)
- Opposition of the legal representative to use the data
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 |
|---|---|---|
| Clinical examination and surveyChildren will be seen during an one consultation. A clinical examination and survey are realized. | Other | Shaken Baby Syndrome |
Primary outcome
the sequelae motor developed by children with a past history of a Shaken Baby Syndrome.
Time frame: At the inclusion (Day 1)
The motor function is assessed by clinical neurological examination.
the cognitive sequelae developed by children with a past history of a Shaken Baby Syndrome
Time frame: At the inclusion (Day 1)
The cognitive function is assessed by the Wechler Scale (WPPSI IV). This scale assesses the verbal understanding, spatial visual understanding, fluid reasoning, work memory and treatment speed.
the behavioral sequelae developed by children with a past history of a Shaken Baby Syndrome.
Time frame: At the inclusion (Day 1)
Adaptive behavior is measured using the Vineland Adaptive Behavior Scales. This scale assesses 4 fields : communication, autonomy, socialization and motor function
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
Related trials for Shaken Baby Syndrome
Not yet recruiting
The Impact of the Nurse-Led "My Baby is Safe" Educational Program
Sudden Infant Death Syndrome, Shaken Baby Syndrome
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.
Pauline Saint Martin, MD-PhD study director
University Hospital, Tours
Questions about this trial
What is this clinical trial studying?
An observational study of Shaken Baby Syndrome, run by University Hospital, Tours.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
the sequelae motor developed by children with a past history of a Shaken Baby Syndrome. (time frame: At the inclusion (Day 1)). The study lists 3 primary outcomes in all. 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 26 Sep 2019.