Perinatal StrokeEPI-STROKENCT07898397
Long-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke
An observational study of Perinatal Stroke and Epilepsy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Perinatal stroke is a rare condition affecting approximately 20-40 births per 100,000. It may be ischemic or hemorrhagic and can occur before or around birth, with diagnosis sometimes delayed until motor or cognitive symptoms emerge. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Perinatal Stroke, Epilepsy, Post-Stroke Epilepsy
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2026to 28 Apr 2027
- Phase
- Observational
- 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 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged 5 to 25 years who attended Strasbourg University Hospitals or Necker Hospital (AP-HP), experienced a confirmed or suspected ischemic or hemorrhagic stroke before 28 days of age, and subsequently developed one of the specified epilepsy syndromes. Patients must meet the inclusion criteria, have sufficient medical record information, and not object to the reuse of their data for research.
Who may be able to join
- Minors aged 5 to under 18 years or adults aged 18 to 25 years.
- Patients who attended one of the two participating centers: Strasbourg University Hospitals or Necker Hospital (AP-HP).
- Confirmed or suspected ischemic or hemorrhagic stroke occurring before 28 days of age.
- During follow-up, presentation of criteria for focal epilepsy, infantile spasms, continuous spike-and-wave during sleep (CSWS), or Lennox-Gastaut syndrome.
Who cannot join
- Birth before 34 weeks of gestation.
- Birth weight below 1,500 g.
- Perinatal hypoxic-ischemic injury with residual MRI lesions.
- Insufficient information in medical records.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Pédiatrie 1 - Hôpital de Hautepierre - CHU de Strasbourg, France
Strasbourg, 67091
Sarah Baer, MD, 33 3 88 12 84 98, sarah.baer@chru-strasbourg.fr
Sarah Baer, MD
About this study
Perinatal stroke is a rare condition affecting approximately 20-40 births per 100,000. It may be ischemic or hemorrhagic and can occur before or around birth, with diagnosis sometimes delayed until motor or cognitive symptoms emerge. Potential long-term consequences include motor deficits, cognitive and learning difficulties, language disorders, and epilepsy.
Post-stroke epilepsy is estimated to affect approximately 30% of children who experience perinatal stroke. Although neonatal outcomes are relatively well characterized, the long-term course of epilepsy in this population and the relationship between initial stroke characteristics and subsequent epilepsy outcomes remain insufficiently studied.
The primary objective of this retrospective, multicenter, observational study is to characterize the long-term course of epilepsy in children who experienced an ischemic or hemorrhagic stroke before 28 days of age.
- Conditions
- Perinatal Stroke, Epilepsy, Post-Stroke Epilepsy
- Keywords
- Perinatal stroke, Pediatric epilepsy, Drug-resistant epilepsy
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-Resistant Epilepsy at 6 Years of Age
Presence of drug-resistant epilepsy at six years of age, defined in the study protocol as requiring more than two treatments.
Measured: At 6 years of age.
Adapted Schooling at 6 Years of Age
Attendance in a specialized educational setting (ULIS or IME) or absence of schooling at six years of age.
Measured: At 6 years of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start28 Apr 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898397
- Sponsor's protocol ID
- RC26_0153
- Acronym
- EPI-STROKE
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke
- ClinicalTrials.gov ID
- NCT07898397
- Acronym / sponsor ID
- EPI-STROKE / RC26_0153
- Conditions
- Perinatal Stroke, Epilepsy, Post-Stroke Epilepsy
- Keywords
- Perinatal stroke, Pediatric epilepsy, Drug-resistant epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Apr 2027 (estimated)
- First posted
- 27 Oct 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.
Perinatal stroke is a rare condition affecting approximately 20-40 births per 100,000. It may be ischemic or hemorrhagic and can occur before or around birth, with diagnosis sometimes delayed until motor or cognitive symptoms emerge. Potential long-term consequences include motor deficits, cognitive and learning difficulties, language disorders, and epilepsy.
Post-stroke epilepsy is estimated to affect approximately 30% of children who experience perinatal stroke. Although neonatal outcomes are relatively well characterized, the long-term course of epilepsy in this population and the relationship between initial stroke characteristics and subsequent epilepsy outcomes remain insufficiently studied.
The primary objective of this retrospective, multicenter, observational study is to characterize the long-term course of epilepsy in children who experienced an ischemic or hemorrhagic stroke before 28 days of age.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 5 to 25 years who attended Strasbourg University Hospitals or Necker Hospital (AP-HP), experienced a confirmed or suspected ischemic or hemorrhagic stroke before 28 days of age, and subsequently developed one of the specified epilepsy syndromes. Patients must meet the inclusion criteria, have sufficient medical record information, and not object to the reuse of their data for research.
Key inclusion criteria (4 listed)
- Minors aged 5 to under 18 years or adults aged 18 to 25 years.
- Patients who attended one of the two participating centers: Strasbourg University Hospitals or Necker Hospital (AP-HP).
- Confirmed or suspected ischemic or hemorrhagic stroke occurring before 28 days of age.
- During follow-up, presentation of criteria for focal epilepsy, infantile spasms, continuous spike-and-wave during sleep (CSWS), or Lennox-Gastaut syndrome.
Key exclusion criteria (5 listed)
- Birth before 34 weeks of gestation.
- Birth weight below 1,500 g.
- Perinatal hypoxic-ischemic injury with residual MRI lesions.
- Insufficient information in medical records.
- Refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Drug-Resistant Epilepsy at 6 Years of Age
Time frame: At 6 years of age.
Presence of drug-resistant epilepsy at six years of age, defined in the study protocol as requiring more than two treatments.
Adapted Schooling at 6 Years of Age
Time frame: At 6 years of age.
Attendance in a specialized educational setting (ULIS or IME) or absence of schooling at six years of age.
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 27 Oct 2026.
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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.
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 Perinatal Stroke and Epilepsy, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 France. 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?
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 Sarah Baer, MD (33 3 88 12 84 98, sarah.baer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug-Resistant Epilepsy at 6 Years of Age (time frame: At 6 years of age.). The study lists 2 primary outcomes in all. 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 27 Oct 2026.