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Completed

NCT Number: NCT06211192

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

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.

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Key information

Age range

1 hour–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Orkun Çetin

Balıkesir, Altieylul, 10100, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retrospective data collection

Other

retrospective data collecting from medical records

Primary outcomes

  1. compile risk elements linked to extended use of anti-seizure medication retrospectively

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Jan 18, 2024
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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