Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04379089 |
| Other study ID # |
STUDY20060012 |
| Secondary ID |
STUDY20040154STU |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 29, 2020 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to perform a secondary analysis of pre-existing de-identified
limited datasets obtained from sites participating in Tier 1 (STUDY20040154: Neurologic
Manifestations of COVID 19 in Children) and Tier 2 (STUDY20040278: Neuro COVID - Outcomes).
The data will be used to determine the prevalence and severity of neurological symptoms among
patients requiring critical care admission for confirmed or suspected novel coronavirus
(COVID-19) and to determine the predictors for limitation of care in the study population, as
well as, the prognosis of neurologically injured patients admitted to the ICU during the
COVID-19 crisis.
This study is sponsored by the Pediatric Neurocritical Care Research Group (PNCRG) and
sponsored and funded in part by the Neurocritical Care Society.
Description:
Early reports of COVID-19 indicate that adults experience a variety of neurological symptoms
and diagnoses in approximately 36% of patients, including headaches, seizures, coma,
encephalitis, and cerebrovascular events including ischemic stroke, intracranial hemorrhage,
and cerebral venous sinus thromboses. In children, recent evidence highlights acute and
long-term neurological manifestations due to other viral illnesses including Guillain Barre
syndrome and neonatal microcephaly with Zika virus, encephalitis with H1N1 influenza, and
acute flaccid paralysis with enterovirus-68. However, COVID-19 reports in children published
thus far lack detailed information on the frequency and outcomes of neurological findings.
COVID-19 cases are rapidly rising internationally, with experts forecasting subsequent global
surges and continued activity. Thus, it is imperative to accurately document prevalence and
outcomes of the neurological aspects of COVID-19 specifically in children. Such data will
serve to alert clinicians and families about the possibility that children may present with
neurologic rather than "classic" symptoms of COVID-19 who nevertheless would warrant testing,
and that neurologic events can occur subsequent to the diagnosis that may impact long-term
outcomes (e.g., cognitive, emotional, physical health). The investigators anticipate that
improved knowledge about neurologic manifestations in children will bolster personalized
treatment and rehabilitation strategies to optimize child outcomes and inform future
interventional studies.
