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| ID | Type | Description | Link |
|---|---|---|---|
| K23NS105918 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| Boston Children's Hospital | OTHER |
| UCSF Benioff Children's Hospital Oakland | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) |
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The purpose of this study evaluate the relationship between inflammation and epilepsy in neonates with seizures after birth.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw | Diagnostic Test | Evaluation of plasma inflammatory markers including cytokines and micro-RNA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At study entry |
| Percentage of participants diagnosed with epilepsy | The investigators will determine the proportion of participants who develop clinical and or electrographic seizures. | 24 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants diagnosed with epilepsy | The investigators will determine the proportion of participants who develop clinical and or electrographic seizures. | 12 months of age |
| Epilepsy Severity |
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For participants in the acute symptomatic seizure group:
Inclusion Criteria:
Exclusion Criteria:
For participants in the control group:
Inclusion Criteria:
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Newborns who are admitted at one of the participating children's hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Adam L Numis, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | United States | ||
| University of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31234194 | Background | 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. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| NIH |
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Plasma.
| Survey | Other | Regarding epilepsy and development. |
|
The investigators will administer an investigator-developed questionnaire designed to define the frequency of seizures (monthly, weekly, daily, or greater than daily).
| 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). | 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. | 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. | Assessment takes up to 15 minutes and will be conducted at 24 months of age |
| San Francisco |
| California |
| 94158 |
| United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan, Mott Children's Hospital | Ann Arbor | Michigan | 48103 | United States |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |