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

Neonatal Seizure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06211192
• Other study ID #: YDKtreat
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: January 2024
• Source: Balikesir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: October 1, 2023
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal Seizure
• Seizures

Intervention

Other:
• retrospective data collection
retrospective data collecting from medical records

Locations

Country	Name	City	State
Turkey	Orkun Çetin	Balikesir	Altieylul

Sponsors (1)

Lead Sponsor	Collaborator
Balikesir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compile risk elements linked to extended use of anti-seizure medication retrospectively	Collecting the risk elements associated with long-term usage of anti-seizure medication from the participants' medical records in a retrospective manner.	1-2 years