Clinical trial NCT06211192: What Are the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures?
Official title: Evaluation of the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures: A Single-center Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Seizure
Keywords: Neonate
Seizure
Early onset epilepsy
anti-seizure medication
acute provoke seizure
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 158
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants are defined as children aged younger than 12 months.According to the International League Against Epilepsy (ILAE) classification of neonatal seizures and their aetiology, 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.

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* Neonates with seizures diagnosed clinically or with conventional electroencephalography (cEEG) confirmation were enrolled.

Exclusion Criteria:

* with abnormal paroxysmal events that weren't determined to be seizures by cEEG, amplitude integrated EEG (aEEG) and video records,
* stopped medications due to their parents' decisions,
* with missing hospital records,
* delivered from pregnancies by assisted reproductive techniques were not enrolled.

Primary outcomes:
measure: compile risk elements linked to extended use of anti-seizure medication retrospectively
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Balikesir
country: Turkey
facility: Orkun Çetin
state: Altieylul
Study officials:
affiliation: Balikesir Üniversite Medical faculty hospital
name: Mustafa Kösecik, Prof
role: STUDY_CHAIR
References: