Trials Sponsors Conditions Drugs Pricing

Conditions

Epilepsy Inflammatory Response Neonatal Seizure Seizures

Keywords

Neonatal seizureInflammationCytokineMicro-RNAEpilepsyEEG

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (5)

Percentage of participants diagnosed with epilepsy
12 months of age

Study Arms (2)

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.

Diagnostic Test: Blood drawOther: 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.

Diagnostic Test: Blood draw

Interventions

Blood drawDiagnostic test

Evaluation of plasma inflammatory markers including cytokines and micro-RNA.

Acute symptomatic seizuresControl

SurveyOther

Regarding epilepsy and development.

Acute symptomatic seizures

Eligibility Criteria

Age1 Day - 4 Days

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

Newborns who are admitted at one of the participating children's hospitals

You may qualify if:

Neonates \<44 weeks corrected age at seizure onset

Sponsors & Collaborators

University of California, San Francisco
Otherlead
University of Michigan
Othercollaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Study Sites (4)

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

University of California, San Francisco

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

Related Publications (1)

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.
PMID: 31234194BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma.

MeSH Terms

Conditions

EpilepsySeizuresInflammation

Interventions

Blood Specimen CollectionSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Study Officials

Adam L Numis, MD
University of California, San Francisco
PRINCIPAL INVESTIGATOR

Enrollment

72 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

December 15, 2018

Actual (reported)

Evaluating the Role of Inflammation in Neonatal Epileptogenesis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Acute symptomatic seizures

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (1)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Acute symptomatic seizures

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (1)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations