Shaken Baby Syndrome Clinical Trial
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.
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.
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