NCT06211192

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
• Phase: —
• Study type: Observational
• Enrollment: 158 (actual)
• Sponsor: Balikesir University · Academic / Other
• Sex: All
• Age: 1 Hour – 2 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Neonatal Seizure

Interventions

Type	Name	Description
OTHER	retrospective data collection	retrospective data collecting from medical records

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-11-01
• Completion: 2023-10-01
• First posted: 2024-01-18
• Last updated: 2024-01-18

Locations

1 site across 1 country: Turkey (Türkiye)