Predictors of Sequelae Appearance in Shaken Baby Syndrome (FPASSBS)

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.

Study Overview

• Status: Withdrawn
• Conditions: Shaken Baby Syndrome
• Intervention / Treatment: Other: Clinical examination and survey

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Shaken Baby Syndrome; Realization of a clinical examination and survey on children with a past history of a Shaken Baby Syndrome	Other: Clinical examination and survey; Children will be seen during an one consultation. A clinical examination and survey are realized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the sequelae motor developed by children with a past history of a Shaken Baby Syndrome.	The motor function is assessed by clinical neurological examination.	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.	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	At the inclusion (Day 1)

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Study Director: Pauline Saint Martin, MD-PhD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2019
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): June 28, 2019

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: brain injury; long-term outcome; sequelae; Shaken Baby Syndrome; abusive head trauma; severity criteria in the admission to hospital for a Shaken Baby Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Syndrome; Shaken Baby Syndrome
• Other Study ID Numbers: RIPH3-RNI18/FPASSBS; 2018-A03098-47 (Other Identifier: IdRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No