None listed
Conditions
Brief summary
Novel coronavirus infection, named COVID-19 by the WHO in early February has reached pandemic scale and now been diagnosed worldwide. Currently over 450k infections and 20k deaths have been reported, with these numbers increasing rapidly. While international vaccine research is being accelerated there are no treatments currently recognised for use in COVID-19. International experience to date has indicated the children are relatively spared from the severe disease seen in adults, with few children around the world requiring invasive ventilatory support. The mechanisms behind this different expression of disease severity is the subject of ongoing studies. While children do not experience severe disease, they are thought to acquire SARS-CoV2 infections and remain relatively well or completely asymptomatic. In addition, the symptoms expressed by many children are similar to other childhood viral infections such as Respiratory Syncytial Virus (RSV) or Influenza. This lack of defining symptoms makes testing criteria and criteria for self-isolation difficult to apply to the paediatric population. In addition, this lack of symptoms makes it more likely for children to remain at school or in the community and potentially spread the SARS CoV2 infection to others with whom they are in contact. This study aims to quantify the presence of infection in children presenting to a metropolitan children’s emergency department and admitted to a children’s inpatient ward. This information can be used by governments and health authorities to inform policy around social distancing, self-isolation and testing criteria in this population. This is a repeating point prevalence study, sampling children presenting to the emergency department (ED) or admitted as an inpatient to the hospital on pre-defined days. Sampling will occur on a weekly basis, preferably on the same day each week although this may be varied for operational reasons. Screening for the inpatient ward and ED may occur on separate days to limit strain on limited nursing resources during this period. Children who present or are admitted to hospital with known SARS-CoV2 infection will be included in the study, however repeat testing is not performed on these children. For children who are admitted to hospital who have previously tested negative for SARS-CoV2 infection, repeat testing will only be performed if more than 72 hours have elapsed since the last swab collection
Interventions
All children presenting or admitted to hospital and pre-defined screening days will be tested for coronavirus, irrespective if they meet current COVID-19 testing guidelines. Screening days will occur on 1 day per week for 3 months. For children who are admitted to hospital who have previously tested negative for SARS-CoV2 infection, repeat testing will only be performed if more than 72 hours have elapsed since the last swab collection'
Data will be collected form participants from the time of s
All children presenting or admitted to hospital and pre-defined screening days will be tested for coronavirus, irrespective if they meet current COVID-19 testing guidelines. Screening days will occur on 1 day per week for 3 months. For children who are admitted to hospital who have previously tested negative for SARS-CoV2 infection, repeat testing will only be performed if more than 72 hours have elapsed since the last swab collection' Data will be collected form participants from the time of screening until 14 days after discharge from hospital. Baseline screening and data collection Demographic and clinical data will be retrospectively collected from the electronic medical record or parents by research staff. This information will include (but is not limited to): - Age - Sex - Indigenous - Postcode - Reason for presentation or admission - First set of vital signs on the day of testing - Fever and symptom history from parent or guardian - Past medical history and co-morbidities - Travel history in past 14 days (including domestic travel) - Contact with known SARS-CoV2 positive people - Attendance at school or other child care facility in the past 14 days - Prior testing undertaken, and details of test (date, result) Discharge information Data will be retrospectively collected after patient discharge and include: - Discharge diagnosis - Bacterial culture, PCR or serology collected during admission and result - Viral PCR or serology collected during admission and results - Emergency Department length of stay - If admitted, hospital length of stay - Need for intensive care admission and/or transfer to high level care - Need for invasive ventilation - Need for other organ supports (cardiovascular, renal replacement, etc) - Outcome of admission (Recovered – no new disability or organ dysfunction, Recovered with new disability or organ dysfunction, Death) Electronic Medical record follow up (day 14) Each participant’s electronic medical record will be reviewed at day 14 to collect information on hospital representations and readmissions. Data collected from the medical record will include: - Number of emergency department presentations and/or hospital admissions - Reason for representation (infection/non-infection) - SARS-CoV2 testing result (positive/negative/not tested) - Discharge destination Sample collection and processing In children less than 12 years of age a nasal swab (Norgen Biotek Corporation) will be collected using standard hospital practice and PPE in accordance with current infection control guidance. In children aged over 12 years a combined oropharyngeal and nasal swab will be collected. RNA will be extracted using commercially available kits (Qiagen, Germany) and analysed by PCR on a quant studio. In participants undergoing blood collection for clinical reasons, an additional 3mLs will be collected into a PAXgene tube. For whole blood samples RNA will be extracted from PAXgene tubes using a Maxwell RSC automated RNA extraction instrument using the commercially available Maxwell RNA Tissue Kit (Promega Corporation, WI, USA. Immune gene expression analysis will be performed using a commercially available NanoString nCounter Immune profiling panel (Nanostring Technologies, WA, USA). The panel includes 770 immune genes. Samples will be transported to Griffith University for testing as a batch, in accordance with standards for the transport of biological samples. Any samples that record a positive result for SARS-CoV2 on testing at the Griffith University laboratory will be referred to the Pathology Queensland laboratory at Gold Coast University for confirmatory testing and reporting through standard local and public health protocols. Results of negative results will not be reported to the participating families by the study team. De-identified samples will be securely stored in the Gold Coast Biobank at Griffith University after completion of testing.
Sponsors
Gold Coast University Hospital
Eligibility
Sex/Gender
All
Age
0 to 16 Years
Healthy volunteers
No
Inclusion criteria
On the pre-defined day of patient screening, each participant must meet all the following criteria to be enrolled in this study: • Is between the ages of 0 and 16 years at enrolment • Is admitted to the Gold Coast University Hospital paediatric inpatient unit, Children’s Critical Care Unit or presenting to the emergency department at Gold Coast University Hospital • Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf.
Exclusion criteria
Contraindication to nasal swab collection
Outcome results
None listed