The GCS-Covid-Peds Study
The GCS-Covid-Peds is a multicenter, multinational cohort observational study to document prevalence and severity of neurological symptoms and outcomes among patients younger than 18 years old admitted to the hospital with confirmed or presumed COVID19.
Early reports of COVID-19 indicate that adults experience a variety of neurologic symptoms and diagnoses in up to 36% of patients. Of note, some patients without any respiratory symptoms had isolated neurologic symptoms of variable severity ranging from anosmia to encephalitis and stroke. Most commonly, adults with COVID-19 have neurologic symptoms prior to and/or during critical respiratory illness that range in severity from headaches, seizures, coma and cerebrovascular events. In children, experience with other viruses has shown delayed awareness of various short- and long-term neurologic complications after or during infection, including Guillain-Barre syndrome and influenza, encephalitis and H1N1 influenza, Acute Flaccid myelitis and enterovirus, microcephaly and Zika, to name a few. Data on neurologic manifestations and outcomes for children with COVID-19 are lacking. This study proposes to address this gap.
The Neurocritical Care Society (NCS) developed an international collaborative to study adult COVID-19 neurologic manifestations. This collaborative includes registered sites from more than 15 countries around the world, and partnerships with other professional organizations for harmonization of common data elements (CDEs) across initiatives. We partnered with NCS to add a pediatric arm upon which we can build a platform using their CDEs (modified for pediatrics as applicable) and adding our own CDEs for outcome assessment after hospital discharge. Accordingly, we divided the pediatric arm into two phases.
Phase 1 of this study will collect data from a variety of sources such as the electronic medical record using an IRB-approved protocol with waiver of consent. Phase 2 of this study would collect data under an IRB-approved protocol with consent for data sharing, outcome collection and/or parent interview.
We invite all interested members to access the NCS link below. Please note NCS membership is not necessary to access the link. After accessing the main link, please then select the portal for pediatric site registration. We will receive weekly lists from NCS of all sites registering. We will provide registered sites with links to obtain a Phase 1 IRB template, CRFs with the approved CDEs, FAQ list and similar resources. A recent publication describing the study design and rationale can be accessed here.
Portal for site registration