Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06211192 |
Other study ID # |
YDKtreat |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2020 |
Est. completion date |
October 1, 2023 |
Study information
Verified date |
January 2024 |
Source |
Balikesir University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The investigators aimed to determine the factors for ceasing anti-seizure medication in
infants who experienced seizures during the neonatal period. This retrospective,
single-center, descriptive study was conducted in Balıkesir between December 2020 and
February 2023, and 157 neonates were recruited.
Description:
This retrospective, single-center, descriptive study was conducted at the Department of
Paediatric Neurology between December 2020 and February 2023, and 157 neonates were recruited
to determine the factors related to ceasing ASM treatment in infants at a follow-up 2 years.
According to the International League Against Epilepsy (ILAE) classification of neonatal
seizures and their etiology, patients who were diagnosed with such seizures and received
anti-seizure medication within the first 28 days of life were followed until their ASM was
ceased after they were discharged from the neonatal intensive care unit. Infants are defined
as children aged younger than 12 months. During this stage of neuronal development, the
central nervous system is more susceptible to the harmful effects of external factors.
Consequently, the investigators have planned to evaluate the study's initial 12-month
follow-up results for our group. Afterwards, the infants were divided into two groups: the
first group consisted of infants who continued to receive ASM treatment after 12 months of
age (referred to as "infants still on ASM after 12 months", n=69); the second group consisted
of infants who had stopped ASM treatment before 12 months of age (referred to as "infants who
had ceased ASM before 12 months", n=88).