Last reviewed · How we verify
NCT04105673: FPASSBS
Predictors of Sequelae Appearance in Shaken Baby Syndrome
trial testing Clinical examination and survey in Shaken Baby Syndrome. Withdrawn.
28 June 2019
Quick facts
| Lead sponsor | University Hospital, Tours |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 28 June 2019 |
| Primary completion | 28 June 2019 |
| Estimated completion | 28 June 2019 |
Drugs / interventions tested
- Clinical examination and survey
Conditions studied
- Shaken Baby Syndrome — all drugs for Shaken Baby Syndrome →
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:
- PubMed search for NCT04105673
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04105673 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Tours
- Last refreshed: 26 September 2019
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