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

Completed

• Conditions: Neonatal Seizure
• Interventions: Other: retrospective data collection

• Registration Number: NCT06211192
• Lead Sponsor: Balikesir University

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).

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-11-01
• Study Completion: 2023-10-01
• Study First Submitted: 2023-12-19
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	retrospective data collection	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)
Group 2	retrospective data collection	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)

Primary Outcome Measures

Name	Time	Method
compile risk elements linked to extended use of anti-seizure medication retrospectively	1-2 years	Collecting the risk elements associated with long-term usage of anti-seizure medication from the participants' medical records in a retrospective manner.

Trial Locations

Locations (1)

Orkun Çetin; 🇹🇷 Balikesir, Altieylul, Turkey