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

Balikesir University

Status: Completed

Conditions: Neonatal Seizure

Treatments: Other: retrospective data collection

Study type: Observational

Funder types: Other

Identifiers

NCT06211192

YDKtreat

Details and patient eligibility

About

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.

Full 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).

Enrollment: 158 patients

Sex: All

Ages: 1 hour to 2 years old

Volunteers: No Healthy Volunteers

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.

Trial design

158 participants in 2 patient groups

Group 1

Description:

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)

Treatment:

Other: retrospective data collection

Group 2

Description:

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)

Treatment:

Other: retrospective data collection