Neurologic Manifestations of COVID 19 in Children

NCT04379089 | Completed

• 3 other identifiers: STUDY20060012STUDY20040154STUDY20040278
• Study Type: observational
• Target: 3,568
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Neurologic Manifestations

Keywords

child; neurocritical care; COVID-19; neurologic manifestations

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Observational study only OTHER

No Intervention

Children <18

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants, children, and young adults age \< 18 years

You may qualify if:

• 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.)

You may not qualify if:

• none

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Utah: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (1)

• Fink EL, Alcamo AM, Lovett M, Hartman M, Williams C, Garcia A, Rasmussen L, Pal R, Drury K, MackDiaz E, Ferrazzano PA, Dervan L, Appavu B, Snooks K, Stulce C, Rubin P, Pate B, Toney N, Robertson CL, Wainwright MS, Roa JD, Schober ME, Slomine BS. Post-discharge outcomes of hospitalized children diagnosed with acute SARS-CoV-2 or MIS-C. Front Pediatr. 2024 Feb 12;12:1340385. doi: 10.3389/fped.2024.1340385. eCollection 2024.

  PMID: 38410766 DERIVED

MeSH Terms

Conditions

Neurologic Manifestations; COVID-19

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ericka L Fink, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Pediatric Critical Care Medicine

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 7, 2020
• Study Start: April 29, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

US (1)