Neonatal SeizureNCT06211192
What Are the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures?
An observational study of Neonatal Seizure, run by Balikesir University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 hour to 2 years
- Conditions the study is for
- Neonatal Seizure
- What is being tested?
- retrospective data collection
- How many people
- 158 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 2 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Neonates with seizures diagnosed clinically or with conventional electroencephalography (cEEG) confirmation were enrolled.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures: A Single-center Retrospective Study
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.
Read the detailed 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).
- Conditions
- Neonatal Seizure
- Being tested
- retrospective data collection
- Keywords
- Neonate, Seizure, Early onset epilepsy, anti-seizure medication, acute provoke seizure
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective data collectionOther
retrospective data collecting from medical records
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: retrospective data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Jan 2020
- Primary completion1 Nov 2021
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İpek Dokurel, Balikesir University
- Investigators
- Mustafa Kösecik, Prof, Study chair, Balikesir Üniversite Medical faculty hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211192
- Sponsor's protocol ID
- YDKtreat
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures: A Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT06211192
- Acronym / sponsor ID
- YDKtreat
- Conditions
- Neonatal Seizure
- Keywords
- Neonate, Seizure, Early onset epilepsy, anti-seizure medication, acute provoke seizure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: retrospective data collectionthe 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) |
| Group 2 | – | Other: retrospective data collectionthe 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 may qualify
- Ages
- 1 hour to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Neonates with seizures diagnosed clinically or with conventional electroencephalography (cEEG) confirmation were enrolled.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospective data collectionretrospective data collecting from medical records | Other | Group 1, Group 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Kösecik, Prof study chair
Balikesir Üniversite Medical faculty hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Seizure, run by Balikesir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compile risk elements linked to extended use of anti-seizure medication retrospectively (time frame: 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.