Consequences of COVID-19 Infection for Child Health and Wellbeing: Protocol for a Prospective, Observational, Longitudinal Study in Children

NCT05799508 | Unknown

• 1 other identifier: ID 3777
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective follow-up of children with SARS-CoV-2

Conditions

Long COVID

Outcome Measures

Primary Outcomes (1)

• number of children developing long covid

  prevalence of post covid condition at 3-6-12-18-24-36 months after SARS-CoV-3 infection

  up to 36 months

Secondary Outcomes (1)

• duration and characteristics of children with long covid, also according to variants

  up to 36 months

Eligibility Criteria

• Age: 4 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients diagnosed with COVID-19 and admitted to the hospitals and/or assessed in primary care among our Institution. Patients will be identified from existing local cohorts. Inclusion criteria: * Children aged 0-18 years * The child sought/needed primary or secondary medical care for COVID-19 * Laboratory (RT-PCR,) \[18\] * 28 days - 3 months from the onset of COVID-19 symptoms * Parent's/carer's/guardian's consent to participate The survey for paediatric follow-up is based on the previously developed adult questionnaire. The survey has been adapted to specific age groups to identify specific symptoms in children.

You may qualify if:

• Children aged 0-18 years
• The child sought/needed primary or secondary medical care for COVID-19
• Laboratory (RT-PCR,) \[18\]
• days - 3 months from the onset of COVID-19 symptoms
• Parent's/carer's/guardian's consent to participate

You may not qualify if:

• adults

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Gemelli

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 5, 2023
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: April 5, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

IT (1)