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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06211192
Other study ID # YDKtreat
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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