Skip to content

What Are the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures?

Evaluation of the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures: A Single-center Retrospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06211192
Enrollment
158
Registered
2024-01-18
Start date
2020-01-01
Completion date
2023-10-01
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Seizure

Keywords

Neonate, Seizure, Early onset epilepsy, anti-seizure medication, acute provoke seizure

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).

Interventions

retrospective data collecting from medical records

Sponsors

Balikesir University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 2 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
compile risk elements linked to extended use of anti-seizure medication retrospectively1-2 yearsCollecting the risk elements associated with long-term usage of anti-seizure medication from the participants' medical records in a retrospective manner.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026