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

NCT06211192 | Completed

• 1 other identifier: YDKtreat
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Seizure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

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)

Other: retrospective data collection

Group 2

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)

Other: retrospective data collection

Interventions

retrospective data collection OTHER

retrospective data collecting from medical records

Group 1; Group 2

Eligibility Criteria

• Age: 1 Hour - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants are defined as children aged younger than 12 months.According to the International League Against Epilepsy (ILAE) classification of neonatal seizures and their aetiology, 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.

You may qualify if:

• Neonates with seizures diagnosed clinically or with conventional electroencephalography (cEEG) confirmation were enrolled.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Orkun Çetin

Balıkesir, Altieylul, 10100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mustafa Kösecik, Prof

  Balikesir Üniversite Medical faculty hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 18, 2024
• Study Start: January 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: October 1, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

TU (1)