Status:
UNKNOWN
Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant
Lead Sponsor:
University Hospital, Caen
Conditions:
Neonatal Hypotonia
Antidepressant Drug Adverse Reaction
Eligibility:
All Genders
1-30 years
Brief Summary
To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants, so far limited to clinical cases, we will perform an observational retrospective pharmacovigilance s...
Eligibility Criteria
Inclusion
- neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs
Exclusion
- Reports with maternal suicide, congenital malformation and hypotonia occurring only during breastfeeding
Key Trial Info
Start Date :
March 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT04830241
Start Date
March 25 2021
End Date
May 1 2021
Last Update
April 5 2021
Active Locations (1)
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1
Caen University Hospital
Caen, Normandy, France, 14000