Evaluating the Role of Inflammation in Neonatal Epileptogenesis
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 05/31/2020 |
| Първо изпратено: | 02/03/2020 |
| Очаквано записване подадено: | 02/03/2020 |
| Първо публикувано: | 02/05/2020 |
| Изпратена последна актуализация: | 06/11/2020 |
| Последна актуализация публикувана: | 06/15/2020 |
| Действителна начална дата на проучването: | 12/14/2018 |
| Приблизителна дата на първично завършване: | 05/30/2023 |
| Очаквана дата на завършване на проучването: | 11/29/2023 |
Състояние или заболяване
Интервенция / лечение
Diagnostic Test: Blood draw
Other: Acute symptomatic seizures
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| 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 within 24-72 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. | Other: Acute symptomatic seizures Regarding epilepsy and development. |
| 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 within 24-96 hours after birth. |
Критерии за допустимост
| Полове, допустими за проучване | All |
| Метод за вземане на проби | Non-Probability Sample |
| Приема здрави доброволци | Не |
| Критерии | For participants in the acute symptomatic seizure group: Inclusion Criteria: - 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) Exclusion Criteria: - 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: Inclusion Criteria: - Neonates that are born > 37 weeks and <44 weeks gestational age - Neonates referred for video-EEG monitoring for spells, with normal EEG AND normal neuroimaging (head ultrasound or MRI) - Neonates considered for cooling but felt not to meet formal criteria for hypoxic ischemic encephalopathy |
Резултат
Първични изходни мерки
1. Seizure burden [At study entry]
2. Percentage of participants diagnosed with epilepsy [24 months of age]
Вторични изходни мерки
1. Percentage of participants diagnosed with epilepsy [12 months of age]
2. Epilepsy Severity [12 months of age]
3. Epilepsy Severity [24 months of age]
4. Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) [Assessment takes up to 15 minutes and will be conducted at 12 months of age]
5. Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) [Assessment takes up to 15 minutes and will be conducted at 24 months of age]
