Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant
Sponsor
University Hospital, Caen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04830241
Collaborator
(none)
10,000
1
1.2
8226.4
Study Details
Study Description
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 study, using two databases. First, disproportionality analysis in Vigibase®, the World Health Organization global database, will be perform between antidepressant drugs and neonatal hypotonia . Second, narratives from the French National Pharmacovigilance Database will be extracted.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
10000 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant-Analysis of Two Pharmacovigilance Databases
Actual Study Start Date
:
Mar 25, 2021
Anticipated Primary Completion Date
:
Apr 15, 2021
Anticipated Study Completion Date
:
May 1, 2021
Outcome Measures
Primary Outcome Measures
- neonatal hypotonia [Case reported in the World Health Organization (WHO) pharmacovigilance database to April 1st 2021]
Identification and extractions of cases of neonatal hypotonia newborns following in utero exposure to antidepressant drugs
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Day
to 30 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs
Exclusion Criteria:
- Reports with maternal suicide, congenital malformation and hypotonia occurring only during breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Caen University Hospital | Caen | Normandy | France | 14000 |
Sponsors and Collaborators
- University Hospital, Caen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT04830241
Other Study ID Numbers:
- HYPOTONIA
First Posted:
Apr 5, 2021
Last Update Posted:
Apr 5, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: