Mobile Video Education and Machine Learning-Based Risk Prediction in Neonatal Seizure Management (NCT07695623) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mobile Video Education and Machine Learning-Based Risk Prediction in Neonatal Seizure Management
60 participantsStarted 2026-07-04
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Maternal Knowledge Level Regarding Neonatal Seizure Management
Timeframe: Baseline, 1 week, 1 month, and 3 months after discharge