Purpose

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.

Conditions

Eligibility

Eligible Ages
Under 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Infants, children, and young adults age < 18 years - Admitted to the hospital with confirmed or presumed COVID-19 infection (includes admissions to emergency, ward, intensive care etc.)

Exclusion Criteria

  • none

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Children <18 Infants, children, and young adults age < 18 years Admitted to the hospital with confirmed or presumed COVID-19 infection (includes admissions to emergency, ward, intensive care etc.)
  • Other: Observational study only
    No Intervention

Recruiting Locations

More Details

NCT ID
NCT04379089
Status
Completed
Sponsor
University of Pittsburgh

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.