Seizure RecurrenceNCT07695623
Mobile Video Education and Machine Learning-Based Risk Prediction in Neonatal Seizure Management
A study testing Mobile Video-Supported Education in people with Seizure Recurrence, run by Istanbul Saglik Bilimleri University.
Trial summary
This mixed-methods study will develop a machine learning-based model to identify infants at high risk of seizure recurrence after discharge from the neonatal intensive care unit. Based on qualitative interviews with mothers, a mobile video-supported education program will be developed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Seizure Recurrence
- What is being tested?
- Mobile Video-Supported Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The infant is classified as high risk according to the machine learning-based risk prediction model developed in the first phase of the study.
- The infant is planned to be discharged home from the Neonatal Intensive Care Unit of Başakşehir Çam and Sakura City Hospital.
- The mother is 18 years of age or older.
- The mother is the primary caregiver responsible for the infant's care.
- The mother is able to read, write, and communicate in Turkish.
- The mother has access to a smartphone and active internet connection, either mobile data or Wi-Fi.
- The mother is able to use a smartphone and basic communication applications such as WhatsApp.
- The mother voluntarily agrees to participate in the study and signs the informed consent form.
Who cannot join
- The infant is transferred to another center before completion of the study process or during the discharge period.
- The infant dies during the study period.
- The mother has a diagnosed cognitive or psychiatric condition that may prevent her from understanding the educational materials or managing the study process.
- The mother has a visual or hearing impairment that may prevent her from following the video content.
- Significant connection problems occur during the qualitative interview process that prevent completion of the interview.
- The mother is unable to access or complete the mobile video education within the first 72 hours after discharge due to technical reasons.
- The mother wishes to withdraw from the study at any stage.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Machine Learning-Based Risk Prediction in Neonatal Seizure Management and the Effect of Mobile Video-Supported Education on Parental Knowledge and Anxiety Levels: A Mixed-Methods Study
This mixed-methods study will develop a machine learning-based model to identify infants at high risk of seizure recurrence after discharge from the neonatal intensive care unit. Based on qualitative interviews with mothers, a mobile video-supported education program will be developed. In the randomized controlled phase, mothers of high-risk infants will be assigned to intervention and control groups to evaluate the effect of the education on knowledge and anxiety levels during follow-up.
Read the detailed description
Neonatal seizures are among the most common neurological emergencies occurring within the first 28 days of life and are associated with significant risks for both short- and long-term neurodevelopmental outcomes. After discharge from the neonatal intensive care unit, seizure recurrence and antiepileptic drug management may create substantial uncertainty and anxiety, particularly for families of high-risk infants. Although the medical management of neonatal seizures and the psychological experiences of parents have been examined separately in the literature, there is a lack of comprehensive approaches that combine technology-based risk prediction with targeted educational interventions.
This study aims to identify infants at high risk of seizure recurrence after discharge by using a machine learning model developed from retrospective clinical data and to evaluate the effect of mobile video-supported education provided to mothers of these infants on their knowledge and anxiety levels.
The study is designed as a mixed-methods study and will be conducted in three phases. In the first phase, retrospective clinical data of infants discharged from the neonatal intensive care unit will be used to develop a machine learning-based risk prediction model for seizure recurrence after discharge. In the second phase, qualitative interviews will be conducted with mothers of high-risk infants to determine their educational needs, concerns, and experiences regarding neonatal seizure management. The findings obtained from these interviews will be used to develop the content of the mobile video-supported education program. In the third phase, mothers of high-risk infants will be randomly assigned to intervention and control groups in a randomized controlled experimental design. The intervention group will receive mobile video-supported education in addition to standard discharge education, while the control group will receive standard discharge education only. The effects of the education program on mothers' knowledge and anxiety levels will be evaluated during the follow-up period.
This study is expected to contribute to the early identification of high-risk infants, support the personalization of nursing care, improve parental knowledge regarding seizure management, and reduce anxiety among mothers caring for infants at risk of seizure recurrence after discharge.
Keywords: Neonatal seizure, machine learning, mobile video education, parental anxiety, knowledge level.
- Conditions
- Seizure Recurrence
- Being tested
- Mobile Video-Supported Education
- Keywords
- Risk prediction, Mobile video-supported education, Machine learning, Maternal knowledge, Neonatal intensive care unit, Antiseizure medication management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Video-Supported EducationBehavioural
The mobile video-supported education program will be provided to mothers of high-risk infants in addition to standard discharge education. The program will include video-based educational content on neonatal seizure recognition, safety precautions, antiseizure medication management, emergency response, and follow-up care after discharge. The education content will be developed based on qualitative interviews with mothers and will aim to improve maternal knowledge and reduce anxiety related to neonatal seizure management.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Mothers in this group will receive standard discharge education only. They will not receive the mobile video-supported education during the intervention period. Their knowledge and anxiety levels will be assessed during the follow-up period. |
| Mobile Video-Supported Education Group | Experimental | Mothers in this group will receive mobile video-supported education in addition to standard discharge education. The education will focus on neonatal seizure recognition, safety measures, antiseizure medication management, emergency response, and follow-up care. Their knowledge and anxiety levels will be assessed during the follow-up period. Receives: Behavioral: Mobile Video-Supported Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maternal Knowledge Level Regarding Neonatal Seizure Management
Maternal knowledge regarding neonatal seizure management will be assessed using a structured knowledge form developed for the study. The form will evaluate mothers' knowledge about seizure recognition, safety measures, antiseizure medication management, emergency response, and follow-up care. Higher scores indicate a higher level of knowledge.
Measured: Baseline, 1 week, 1 month, and 3 months after discharge
Secondary outcomes (1)
Change in Maternal Anxiety Level Assessed by the State-Trait Anxiety Inventory (STAI)
Maternal anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). The scale consists of two subscales: State Anxiety and Trait Anxiety, each including 20 items. Scores range from 20 to 80 for each subscale, with higher scores indicating higher anxiety levels. Changes in anxiety scores between the intervention and control groups will be evaluated during follow-up.
Measured: Baseline, 1 week, 1 month, and 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start4 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Seizure RecurrenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mothers of high-risk infants will be randomly assigned to two parallel groups. The intervention group will receive mobile video-supported education in addition to standard discharge education. The control group will receive standard discharge education only. Outcomes will be assessed during follow-up to evaluate the effect of the education program on maternal knowledge and anxiety levels.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Aktaş, Istanbul Saglik Bilimleri University
- Investigators
- Eda Aktaş, Principal investigator, University of Health Sciences Turkey, Hamidiye Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695623
- Sponsor's protocol ID
- ISBU-SBE-KE-01
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared due to privacy and confidentiality considerations related to maternal and neonatal clinical data.
Publications
Shellhaas RA, Wusthoff CJ, Numis AL, Chu CJ, Massey SL, Abend NS, Soul JS, Chang T, Lemmon ME, Thomas C, McNamara NA, Guillet R, Franck LS, Sturza J, McCulloch CE, Glass HC. Early-life epilepsy after acute symptomatic neonatal seizures: A prospective multicenter study. Epilepsia. 2021 Aug;62(8):1871-1882. doi: 10.1111/epi.16978. Epub 2021 Jul 2.
PubMed 34212365Glass HC, Soul JS, Chang T, Wusthoff CJ, Chu CJ, Massey SL, Abend NS, Lemmon M, Thomas C, Numis AL, Guillet R, Sturza J, McNamara NA, Rogers EE, Franck LS, McCulloch CE, Shellhaas RA. Safety of Early Discontinuation of Antiseizure Medication After Acute Symptomatic Neonatal Seizures. JAMA Neurol. 2021 Jul 1;78(7):817-825. doi: 10.1001/jamaneurol.2021.1437.
PubMed 34028496Pressler RM, Abend NS, Auvin S, Boylan G, Brigo F, Cilio MR, De Vries LS, Elia M, Espeche A, Hahn CD, Inder T, Jette N, Kakooza-Mwesige A, Mader S, Mizrahi EM, Moshe SL, Nagarajan L, Noyman I, Nunes ML, Samia P, Shany E, Shellhaas RA, Subota A, Triki CC, Tsuchida T, Vinayan KP, Wilmshurst JM, Yozawitz EG, Hartmann H. Treatment of seizures in the neonate: Guidelines and consensus-based recommendations-Special report from the ILAE Task Force on Neonatal Seizures. Epilepsia. 2023 Oct;64(10):2550-2570. doi: 10.1111/epi.17745. Epub 2023 Sep 1.
PubMed 37655702
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning-Based Risk Prediction in Neonatal Seizure Management and the Effect of Mobile Video-Supported Education on Parental Knowledge and Anxiety Levels: A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT07695623
- Acronym / sponsor ID
- ISBU-SBE-KE-01
- Conditions
- Seizure Recurrence
- Keywords
- Risk prediction, Mobile video-supported education, Machine learning, Maternal knowledge, Neonatal intensive care unit, Antiseizure medication management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 4 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Jul 2026 (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.
This mixed-methods study will develop a machine learning-based model to identify infants at high risk of seizure recurrence after discharge from the neonatal intensive care unit. Based on qualitative interviews with mothers, a mobile video-supported education program will be developed. In the randomized controlled phase, mothers of high-risk infants will be assigned to intervention and control groups to evaluate the effect of the education on knowledge and anxiety levels during follow-up.
Detailed description
Neonatal seizures are among the most common neurological emergencies occurring within the first 28 days of life and are associated with significant risks for both short- and long-term neurodevelopmental outcomes. After discharge from the neonatal intensive care unit, seizure recurrence and antiepileptic drug management may create substantial uncertainty and anxiety, particularly for families of high-risk infants. Although the medical management of neonatal seizures and the psychological experiences of parents have been examined separately in the literature, there is a lack of comprehensive approaches that combine technology-based risk prediction with targeted educational interventions.
This study aims to identify infants at high risk of seizure recurrence after discharge by using a machine learning model developed from retrospective clinical data and to evaluate the effect of mobile video-supported education provided to mothers of these infants on their knowledge and anxiety levels.
The study is designed as a mixed-methods study and will be conducted in three phases. In the first phase, retrospective clinical data of infants discharged from the neonatal intensive care unit will be used to develop a machine learning-based risk prediction model for seizure recurrence after discharge. In the second phase, qualitative interviews will be conducted with mothers of high-risk infants to determine their educational needs, concerns, and experiences regarding neonatal seizure management. The findings obtained from these interviews will be used to develop the content of the mobile video-supported education program. In the third phase, mothers of high-risk infants will be randomly assigned to intervention and control groups in a randomized controlled experimental design. The intervention group will receive mobile video-supported education in addition to standard discharge education, while the control group will receive standard discharge education only. The effects of the education program on mothers' knowledge and anxiety levels will be evaluated during the follow-up period.
This study is expected to contribute to the early identification of high-risk infants, support the personalization of nursing care, improve parental knowledge regarding seizure management, and reduce anxiety among mothers caring for infants at risk of seizure recurrence after discharge.
Keywords: Neonatal seizure, machine learning, mobile video education, parental anxiety, knowledge level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mothers of high-risk infants will be randomly assigned to two parallel groups. The intervention group will receive mobile video-supported education in addition to standard discharge education. The control group will receive standard discharge education only. Outcomes will be assessed during follow-up to evaluate the effect of the education program on maternal knowledge and anxiety levels.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Mothers in this group will receive standard discharge education only. They will not receive the mobile video-supported education during the intervention period. Their knowledge and anxiety levels will be assessed during the follow-up period. |
| Mobile Video-Supported Education Group | Experimental | Behavioral: Mobile Video-Supported EducationMothers in this group will receive mobile video-supported education in addition to standard discharge education. The education will focus on neonatal seizure recognition, safety measures, antiseizure medication management, emergency response, and follow-up care. Their knowledge and anxiety levels will be assessed during the follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The infant is classified as high risk according to the machine learning-based risk prediction model developed in the first phase of the study.
- The infant is planned to be discharged home from the Neonatal Intensive Care Unit of Başakşehir Çam and Sakura City Hospital.
- The mother is 18 years of age or older.
- The mother is the primary caregiver responsible for the infant's care.
- The mother is able to read, write, and communicate in Turkish.
Key exclusion criteria (7 listed)
- The infant is transferred to another center before completion of the study process or during the discharge period.
- The infant dies during the study period.
- The mother has a diagnosed cognitive or psychiatric condition that may prevent her from understanding the educational materials or managing the study process.
- The mother has a visual or hearing impairment that may prevent her from following the video content.
- Significant connection problems occur during the qualitative interview process that prevent completion of the interview.
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 |
|---|---|---|
| Mobile Video-Supported EducationThe mobile video-supported education program will be provided to mothers of high-risk infants in addition to standard discharge education. The program will include video-based educational content on neonatal seizure recognition, safety precautions, antiseizure medication management, emergency response, and follow-up care after discharge. The education content will be developed based on qualitative interviews with mothers and will aim to improve maternal knowledge and reduce anxiety related to neonatal seizure management. | Behavioural | Mobile Video-Supported Education Group |
Primary outcome
Change in Maternal Knowledge Level Regarding Neonatal Seizure Management
Time frame: Baseline, 1 week, 1 month, and 3 months after discharge
Maternal knowledge regarding neonatal seizure management will be assessed using a structured knowledge form developed for the study. The form will evaluate mothers' knowledge about seizure recognition, safety measures, antiseizure medication management, emergency response, and follow-up care. Higher scores indicate a higher level of knowledge.
1 secondary outcome
Change in Maternal Anxiety Level Assessed by the State-Trait Anxiety Inventory (STAI)
Time frame: Baseline, 1 week, 1 month, and 3 months after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 34212365Shellhaas RA, Wusthoff CJ, Numis AL, Chu CJ, Massey SL, Abend NS, Soul JS, Chang T, Lemmon ME, Thomas C, McNamara NA, Guillet R, Franck LS, Sturza J, McCulloch CE, Glass HC. Early-life epilepsy after acute symptomatic neonatal seizures: A prospective multicenter study. Epilepsia. 2021 Aug;62(8):1871-1882. doi: 10.1111/epi.16978. Epub 2021 Jul 2.
- Background: PubMed 34028496Glass HC, Soul JS, Chang T, Wusthoff CJ, Chu CJ, Massey SL, Abend NS, Lemmon M, Thomas C, Numis AL, Guillet R, Sturza J, McNamara NA, Rogers EE, Franck LS, McCulloch CE, Shellhaas RA. Safety of Early Discontinuation of Antiseizure Medication After Acute Symptomatic Neonatal Seizures. JAMA Neurol. 2021 Jul 1;78(7):817-825. doi: 10.1001/jamaneurol.2021.1437.
- Background: PubMed 37655702Pressler RM, Abend NS, Auvin S, Boylan G, Brigo F, Cilio MR, De Vries LS, Elia M, Espeche A, Hahn CD, Inder T, Jette N, Kakooza-Mwesige A, Mader S, Mizrahi EM, Moshe SL, Nagarajan L, Noyman I, Nunes ML, Samia P, Shany E, Shellhaas RA, Subota A, Triki CC, Tsuchida T, Vinayan KP, Wilmshurst JM, Yozawitz EG, Hartmann H. Treatment of seizures in the neonate: Guidelines and consensus-based recommendations-Special report from the ILAE Task Force on Neonatal Seizures. Epilepsia. 2023 Oct;64(10):2550-2570. doi: 10.1111/epi.17745. Epub 2023 Sep 1.
- Individual participant dataSharing planned: No. No individual participant data will be shared due to privacy and confidentiality considerations related to maternal and neonatal clinical data.
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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.
Eda Aktaş principal investigator
University of Health Sciences Turkey, Hamidiye Faculty of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Video-Supported Education in people with Seizure Recurrence, run by Istanbul Saglik Bilimleri University.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kübra Ergün, PhD Student, MSc, RN (+90 534 819 12 20, kubraergunn95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maternal Knowledge Level Regarding Neonatal Seizure Management (time frame: Baseline, 1 week, 1 month, and 3 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07695623, which also lists 3 linked publications.
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 10 Jul 2026.