Neurologic Manifestations of COVID 19 in Children

Sponsor

University of Pittsburgh (Other)

Overall Status

Recruiting

CT.gov ID

NCT04379089

Collaborator

University of Utah (Other), Johns Hopkins University (Other)

1,000

Enrollment

Location

32.1

Anticipated Duration (Months)

31.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID Neurologic Manifestations	Other: Observational study only

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Neurologic Manifestations of COVID 19 in Children

Actual Study Start Date :

Apr 29, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Prevalence [1 year]
Determine the prevalence of neurological manifestations and association with outcome in children with confirmed or presumed COVID-19 and/or MISC hospitalized between January 2020 and December 2021.
Child and family health functions [1 month post discharge]
Measure child and family health functions and health-related quality of life (HRQOL) outcomes post discharge in children with confirmed or presumed COVID-19 and/or MISC diagnoses.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224

Sponsors and Collaborators

University of Pittsburgh
University of Utah
Johns Hopkins University

Investigators

Principal Investigator: Ericka L Fink, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ericka Fink, Associate Professor, Division of Pediatric Critical Care Medicine, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT04379089

Other Study ID Numbers:

STUDY20060012
STUDY20040154
STUDY20040278

First Posted:

May 7, 2020

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ericka Fink, Associate Professor, Division of Pediatric Critical Care Medicine, University of Pittsburgh

child

neurocritical care

COVID-19

neurologic manifestations

Additional relevant MeSH terms:

COVID-19

Neurologic Manifestations

Study Results

No Results Posted as of Mar 31, 2022