Neurologic Manifestations of COVID 19 in Children

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.

Study Overview

• Status: Completed
• Conditions: Neurologic Manifestations; COVID
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 3568

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Infants, children, and young adults age < 18 years

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence	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.	1 year
Child and family health functions	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.	1 month post discharge

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Johns Hopkins University; University of Utah
• Investigators: Principal Investigator: Ericka L Fink, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; child; neurologic manifestations; neurocritical care
• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Neurologic Manifestations
• Other Study ID Numbers: STUDY20060012; STUDY20040154 (Other Identifier: University of Pittsburgh); STUDY20040278 (Other Identifier: University of Pittsburgh)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No