Clinical trial NCT04105673: Predictors of Sequelae Appearance in Shaken Baby Syndrome
Official title: Prognostic Factors for Sequelae in Children With a History of Shaken Baby Syndrome in the Central Region
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
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
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children concerned had been admitted to hospital for Shaken Baby Syndrome before one year old in France, in the Central region

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Opposition of the legal representative to use the data

Primary outcomes:
measure: the sequelae motor developed by children with a past history of a Shaken Baby Syndrome.
timeFrame: At the inclusion (Day 1)
measure: the cognitive sequelae developed by children with a past history of a Shaken Baby Syndrome
timeFrame: At the inclusion (Day 1)
measure: the behavioral sequelae developed by children with a past history of a Shaken Baby Syndrome.
timeFrame: At the inclusion (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Tours
name: Pauline Saint Martin, MD-PhD
role: STUDY_DIRECTOR
References: