Last reviewed · How we verify

NCT04105673: FPASSBS

Predictors of Sequelae Appearance in Shaken Baby Syndrome

Withdrawn Last updated 26 September 2019
What this trial tests

trial testing Clinical examination and survey in Shaken Baby Syndrome. Withdrawn.

Timeline
28 June 2019
Primary endpoint
28 June 2019
28 June 2019

Quick facts

Lead sponsorUniversity Hospital, Tours
StatusWithdrawn
Study typeOBSERVATIONAL
Start date28 June 2019
Primary completion28 June 2019
Estimated completion28 June 2019

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Tours

Who can join

Adults 5 to 8, any sex, with Shaken Baby Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other University Hospital, Tours trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04105673.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing