Predictors of Sequelae Appearance in Shaken Baby Syndrome

Withdrawn

• Conditions: Shaken Baby Syndrome
• Interventions: Other: Clinical examination and survey

• Registration Number: NCT04105673
• Lead Sponsor: University Hospital, Tours

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.

Study Timeline

• Study First Submitted: 2019-01-11
• Study Start: 2019-06-28
• Primary Completion: 2019-06-28
• Study Completion: 2019-06-28
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-25
• Last Update Submitted: 2019-09-25
• Study First Posted: 2019-09-26
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Shaken Baby Syndrome	Clinical examination and survey	Realization of a clinical examination and survey on children with a past history of a Shaken Baby Syndrome

Primary Outcome Measures

Name	Time	Method
the sequelae motor developed by children with a past history of a Shaken Baby Syndrome.	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	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.	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