Status:
COMPLETED
Neurodevelopmental Outcome After Prenatal Anesthesia
Lead Sponsor:
University Hospital, Caen
Conditions:
Neurodevelopmental Disorders
Child Behavior
Eligibility:
All Genders
5-12 years
Brief Summary
In 2016, the US Food and Drug Administration raised concerns about the potential negative effects of anesthesia exposure on neurodevelopment in children during pregnancy or before the age of three. T...
Detailed Description
The study : "Association Between Prenatal Anesthesia Exposure and Neurodevelopmental Outcome : an Ambidirectional Cohort Study" is a single-center, ambidirectional, observational cohort study conducte...
Eligibility Criteria
Inclusion
- Children born between 2011 and 2018 at Caen University Hospital
- Children whose mothers underwent surgery for non-obstetrical reasons under general or locoregional anesthesia, or did not undergo any surgical intervention.
Exclusion
- Lost to follow-up
- Incomplete medical files
- Refusal of either parent or legal guardian
- Children with condition presenting independent risk factors for impaired neurocognitive development such as : neonatal hypoxia-ischemia, neurological disorder, neuromuscular disorder, complex cardiac or genetic disorders
- Children with a known or suspected genetic syndrome
- Preterm-born children (defined as birth at less than 37 weeks of amenorrhea)
- Cesarean-born children
Key Trial Info
Start Date :
October 9 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 26 2024
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06052878
Start Date
October 9 2023
End Date
February 26 2024
Last Update
March 26 2025
Active Locations (1)
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1
University Hospital Caen Normandie
Caen, Normandy, France, 14000