A Study of the Infection and Transmission of SARS-CoV-2 in Paediatric Patients

NCT05137535 | Unknown

• 1 other identifier: PLS COVID 19 - Prog. 3401CESC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Covid-19 disease, originated by SARS-Cov-2 Coronavirus, officially appeared in Italy in February 2020. Children and adolescents, in most cases, have an asymptomatic or paucisymptomatic clinical picture and are very rarely hospitalized. Precisely because of the modest symptoms presented, information on the natural history of Covid19 disease and its symptomatology is still limited. Because almost all children with Covid19 are treated by community medicine, family pediatricians are the most suitable figures to collect the clinical history of these patients. Information regarding the mode of infection and spread at both the intrafamily and school levels is also poor, and the role that the opening of schools may have on the spread of infection is not yet well established. However, scientific evidence supports the adverse effect of school closures on the physical and mental health of children and adolescents. Analysis of school spread in a specific area can therefore contribute to increased knowledge about the role of schools, and such information may be useful in guiding health policy choices.

Conditions

Covid19

Keywords

Covid-19; SARS-CoV-2; children; pediatric; transmission; clinical features

Outcome Measures

Primary Outcomes (2)

• Natural history

  Description of the natural history of Covid19 in paediatric patients in terms of length, severity and symptoms

  Feb. 1, 2020 - Dec. 31, 2021

• Infection and spread

  Description of the mode of infection and spread at both the intrafamily and school levels using suitable statistical models

  Feb. 1, 2020 - Dec. 31, 2021

Secondary Outcomes (2)

• School opening

  Feb. 1, 2020 - Dec. 31, 2021

• Monitoring

  Feb. 1, 2020 - Dec. 31, 2021

Study Arms (1)

Children diagnosed with Covid-19

Pediatric patients enrolled by the family pediatricians participating in this study, affected by Covid-19 disease whose diagnosis was confirmed by SARS-Cov-2 molecular test

Other: Questionnaire

Interventions

Questionnaire OTHER

Family-based questionnaire

Children diagnosed with Covid-19

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients enrolled by the family pediatricians participating in this study, affected by Covid-19 disease whose diagnosis was confirmed by SARS-Cov-2 molecular test

Pediatric patients affected by Covid-19 disease whose diagnosis was confirmed by SARS-Cov-2 molecular test enrolled by the family pediatricians participating in this study from February 1 2020 to December 31 2021

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Padova: lead
• Azienda ULSS 5 Polesana: collaborator
• Imperial College London: collaborator

Study Sites (1)

AULSS 5 Polesana

Rovigo, RO, Italy

RECRUITING

Related Publications (4)

• Mehta NS, Mytton OT, Mullins EWS, Fowler TA, Falconer CL, Murphy OB, Langenberg C, Jayatunga WJP, Eddy DH, Nguyen-Van-Tam JS. SARS-CoV-2 (COVID-19): What Do We Know About Children? A Systematic Review. Clin Infect Dis. 2020 Dec 3;71(9):2469-2479. doi: 10.1093/cid/ciaa556.

  PMID: 32392337 BACKGROUND

• Posfay-Barbe KM, Wagner N, Gauthey M, Moussaoui D, Loevy N, Diana A, L'Huillier AG. COVID-19 in Children and the Dynamics of Infection in Families. Pediatrics. 2020 Aug;146(2):e20201576. doi: 10.1542/peds.2020-1576. Epub 2020 May 26. No abstract available.

  PMID: 32457213 BACKGROUND

• Dorigatti I, Lavezzo E, Manuto L, Ciavarella C, Pacenti M, Boldrin C, Cattai M, Saluzzo F, Franchin E, Del Vecchio C, Caldart F, Castelli G, Nicoletti M, Nieddu E, Salvadoretti E, Labella B, Fava L, Guglielmo S, Fascina M, Grazioli M, Alvisi G, Vanuzzo MC, Zupo T, Calandrin R, Lisi V, Rossi L, Castagliuolo I, Merigliano S, Unwin HJT, Plebani M, Padoan A, Brazzale AR, Toppo S, Ferguson NM, Donnelly CA, Crisanti A. SARS-CoV-2 antibody dynamics and transmission from community-wide serological testing in the Italian municipality of Vo'. Nat Commun. 2021 Jul 19;12(1):4383. doi: 10.1038/s41467-021-24622-7.

  PMID: 34282139 BACKGROUND

• European Centre for Disease Prevention and Control. TECHNICAL REPORT COVID-19 in children and the role of school settings in transmission - update 23 December 2020.

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Alessandra R. Brazzale, PhD

CONTACT

+39 049 827 4136; alessandra.brazzale@unipd.it

Emanuela Frascella, MD, PhD

CONTACT

+39 347 4194941; ela.frascella@gmail.com

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: November 30, 2021
• Study Start: November 3, 2021
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)