Neonatal SeizureNSR-RISENCT04259125
Evaluating the Role of Inflammation in Neonatal Epileptogenesis
An observational study of Neonatal Seizure and Epilepsy, run by University of California, San Francisco at 4 sites in United States.
Trial summary
The purpose of this study evaluate the relationship between inflammation and epilepsy in neonates with seizures after birth. Read more about this study
- Who is it for?
- Ages 1 day to 4 days
- Conditions the study is for
- Neonatal Seizure, Epilepsy, Seizures
- What is being tested?
- Blood draw and Survey
- How many people
- 72 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Dec 2018to 1 Dec 2025
- 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 day to 4 days
- All sexes
- No healthy volunteers
- Child
Study population: Newborns who are admitted at one of the participating children's hospitals
Who may be able to join
- Neonates <44 weeks corrected age at seizure onset
- Seizures due to acute brain injury
- Parent(s) who are English or Spanish literate (with assistance of interpreter)
- Neonates that are born > 37 weeks and <44 weeks postmenstrual age at enrollment
- Consultation by the pediatric neurology inpatient service due neonatal paroxysmal events, with normal neurologic examination and ultimate diagnosis of non-epileptic spells on continuous video-EEG (ordered for clinical purposes, not for research) OR consultation for hypoxic ischemic encephalopathy in neonates undergoing therapeutic hypothermia, with early exit from therapy owing to normal neurologic examination, normal continuous video-EEG and uncertain diagnosis of encephalopathy.
- Neonates requiring neurologic consultation for mild hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia, with normal examination, cEEG, and neuroimaging upon rewarming.
Who cannot join
- Neonates at risk for adverse outcome independent of seizures and underlying brain injury
- Neonates with mild, temporary causes for seizures
- Newborns with neonatal-onset epilepsy syndromes
- Neonates who do not survive the initial hospital admission
- Neonates will not be excluded based on race, ethnicity, gender or gestational age
- For participants in the control group:
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan, Mott Children's Hospital
Ann Arbor, Michigan, 48103
Boston Children's Hospital
Boston, Massachusetts, 02115
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Neonatal Seizure Registry: The Role of Inflammation After Neonatal Seizures and Later Development of Epilepsy
The purpose of this study evaluate the relationship between inflammation and epilepsy in neonates with seizures after birth.
Read the detailed description
Seizures are a common symptom of neurologic dysfunction in the neonatal period, affecting more than 16,000 newborns in the United States per year. Over 25% of neonates with acute symptomatic seizures develop post- neonatal epilepsy (PNE), which is often resistant to medical therapies. There is a critical need to identify those patients most at risk for PNE and understand the mechanisms by which early seizures increase the propensity for recurrent seizures, in hopes of identifying novel therapeutic targets in this population. There is increasing evidence for the role of neuro-inflammation in the development of epilepsy. Levels of cytokines and micro-RNA (miRNA) may serve as markers of disease severity and have been implicated in epileptogenesis in animal models. The purpose of this study is to evaluate plasma cytokine and miRNA levels after neonatal-onset acute symptomatic seizures and determine their association with acute seizure severity and PNE.
- Conditions
- Neonatal Seizure, Epilepsy, Seizures, Inflammatory Response
- Being tested
- Blood draw, Survey
- Keywords
- Neonatal seizure, Inflammation, Cytokine, Micro-RNA, Epilepsy, EEG
- Medical subject headings
- Epilepsy, Seizures, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawDiagnostic test
Evaluation of plasma inflammatory markers including cytokines and micro-RNA.
SurveyOther
Regarding epilepsy and development.
| Study group | Role | What they receive |
|---|---|---|
| Acute symptomatic seizures | This is a cohort of 72 participants who will be enrolled into this study from the neonatal intensive care unit (NICU) after being diagnosed with seizures. They will be asked to contribute a blood specimen obtained ideally 48-96 hours (though blood collection allowed 24-120 hours) after seizures are diagnosed, to participate in an optional blood draw at 2-4 months of age, and to complete surveys at 12 \& 24 months of age. Receives: Diagnostic Test: Blood draw; Other: Survey | |
| Control | This is a cohort of 15 participants who will be enrolled into this study from the neonatal intensive care unit (NICU) after having an EEG for possible seizures, but found to have a normal EEG. They will be asked to contribute a blood specimen obtained ideally 48-96 hours (though blood collection allowed 24-120 hours) after birth. Receives: Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure burden
Investigators will evaluate the seizure burden from the initial diagnostic electroencephalogram (EEG) after birth by determining the average number of seizures per hour.
Measured: At study entry
Percentage of participants diagnosed with epilepsy
The investigators will determine the proportion of participants who develop clinical and or electrographic seizures.
Measured: 24 months of age
Secondary outcomes (5)
Percentage of participants diagnosed with epilepsy
The investigators will determine the proportion of participants who develop clinical and or electrographic seizures.
Measured: 12 months of age
Epilepsy Severity
The investigators will administer an investigator-developed questionnaire designed to define the frequency of seizures (monthly, weekly, daily, or greater than daily).
Measured: 12 months of age
Epilepsy Severity
The investigators will administer an investigator-developed questionnaire designed to define the frequency of seizures (monthly, weekly, daily, or greater than daily).
Measured: 24 months of age
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)
The Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be assessed at 12 months of age. The score ranges from 50 to 200 with higher scores associated with normal development.
Measured: Assessment takes up to 15 minutes and will be conducted at 12 months of age
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)
The Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be assessed at 24 months of age. The score ranges from 50 to 200 with higher scores associated with normal development.
Measured: Assessment takes up to 15 minutes and will be conducted at 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start15 Dec 2018
- Primary completion1 Nov 2024
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal SeizureStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Boston Children's Hospital, UCSF Benioff Children's Hospital Oakland, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Adam L Numis, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259125
- Sponsor's protocol ID
- K23NS105918
- Other IDs
- K23NS105918
- Acronym
- NSR-RISE
- Status last verified
- Jan 2026
- First submitted
- 4 Feb 2020
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Numis AL, Foster-Barber A, Deng X, Rogers EE, Barkovich AJ, Ferriero DM, Glass HC. Early changes in pro-inflammatory cytokine levels in neonates with encephalopathy are associated with remote epilepsy. Pediatr Res. 2019 Nov;86(5):616-621. doi: 10.1038/s41390-019-0473-x. Epub 2019 Jun 24.
PubMed 31234194
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Seizure Registry: The Role of Inflammation After Neonatal Seizures and Later Development of Epilepsy
- ClinicalTrials.gov ID
- NCT04259125
- Acronym / sponsor ID
- NSR-RISE / K23NS105918
- Conditions
- Neonatal Seizure, Epilepsy, Seizures, Inflammatory Response
- Keywords
- Neonatal seizure, Inflammation, Cytokine, Micro-RNA, Epilepsy, EEG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Michigan, Boston Children's Hospital, UCSF Benioff Children's Hospital Oakland, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 6 Feb 2020 (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 purpose of this study evaluate the relationship between inflammation and epilepsy in neonates with seizures after birth.
Detailed description
Seizures are a common symptom of neurologic dysfunction in the neonatal period, affecting more than 16,000 newborns in the United States per year. Over 25% of neonates with acute symptomatic seizures develop post- neonatal epilepsy (PNE), which is often resistant to medical therapies. There is a critical need to identify those patients most at risk for PNE and understand the mechanisms by which early seizures increase the propensity for recurrent seizures, in hopes of identifying novel therapeutic targets in this population. There is increasing evidence for the role of neuro-inflammation in the development of epilepsy. Levels of cytokines and micro-RNA (miRNA) may serve as markers of disease severity and have been implicated in epileptogenesis in animal models. The purpose of this study is to evaluate plasma cytokine and miRNA levels after neonatal-onset acute symptomatic seizures and determine their association with acute seizure severity and PNE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute symptomatic seizures | – | Diagnostic Test: Blood draw, Other: SurveyThis is a cohort of 72 participants who will be enrolled into this study from the neonatal intensive care unit (NICU) after being diagnosed with seizures. They will be asked to contribute a blood specimen obtained ideally 48-96 hours (though blood collection allowed 24-120 hours) after seizures are diagnosed, to participate in an optional blood draw at 2-4 months of age, and to complete surveys at 12 \& 24 months of age. |
| Control | – | Diagnostic Test: Blood drawThis is a cohort of 15 participants who will be enrolled into this study from the neonatal intensive care unit (NICU) after having an EEG for possible seizures, but found to have a normal EEG. They will be asked to contribute a blood specimen obtained ideally 48-96 hours (though blood collection allowed 24-120 hours) after birth. |
Who may qualify
- Ages
- 1 day to 4 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns who are admitted at one of the participating children's hospitals
Key inclusion criteria (6 listed)
- Neonates <44 weeks corrected age at seizure onset
- Seizures due to acute brain injury
- Parent(s) who are English or Spanish literate (with assistance of interpreter)
- Neonates that are born > 37 weeks and <44 weeks postmenstrual age at enrollment
- Consultation by the pediatric neurology inpatient service due neonatal paroxysmal events, with normal neurologic examination and ultimate diagnosis of non-epileptic spells on continuous video-EEG (ordered for clinical purposes, not for research) OR consultation for hypoxic ischemic encephalopathy in neonates undergoing therapeutic hypothermia, with early exit from therapy owing to normal neurologic examination, normal continuous video-EEG and uncertain diagnosis of encephalopathy.
Key exclusion criteria (6 listed)
- Neonates at risk for adverse outcome independent of seizures and underlying brain injury
- Neonates with mild, temporary causes for seizures
- Newborns with neonatal-onset epilepsy syndromes
- Neonates who do not survive the initial hospital admission
- Neonates will not be excluded based on race, ethnicity, gender or gestational age
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 |
|---|---|---|
| Blood drawEvaluation of plasma inflammatory markers including cytokines and micro-RNA. | Diagnostic test | Acute symptomatic seizures, Control |
| SurveyRegarding epilepsy and development. | Other | Acute symptomatic seizures |
Primary outcome
Seizure burden
Time frame: At study entry
Investigators will evaluate the seizure burden from the initial diagnostic electroencephalogram (EEG) after birth by determining the average number of seizures per hour.
Percentage of participants diagnosed with epilepsy
Time frame: 24 months of age
The investigators will determine the proportion of participants who develop clinical and or electrographic seizures.
5 secondary outcomes
Percentage of participants diagnosed with epilepsy
Time frame: 12 months of age
Epilepsy Severity
Time frame: 12 months of age
Epilepsy Severity
Time frame: 24 months of age
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)
Time frame: Assessment takes up to 15 minutes and will be conducted at 12 months of age
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)
Time frame: Assessment takes up to 15 minutes and will be conducted at 24 months of age
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 26 Jan 2026.
- Background: PubMed 31234194Numis AL, Foster-Barber A, Deng X, Rogers EE, Barkovich AJ, Ferriero DM, Glass HC. Early changes in pro-inflammatory cytokine levels in neonates with encephalopathy are associated with remote epilepsy. Pediatr Res. 2019 Nov;86(5):616-621. doi: 10.1038/s41390-019-0473-x. Epub 2019 Jun 24.
- Individual participant dataSharing planned: No
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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.
Adam L Numis, MD principal investigator
University of California, San Francisco
4 sites 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 and Epilepsy, run by University of California, San Francisco at 4 sites in United States.
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 6 inclusion and 6 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 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Seizure burden (time frame: At study entry). 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?
On the ClinicalTrials.gov record for NCT04259125, which also lists 1 linked publication.
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 26 Jan 2026.