Symptom Patterns and Life With Longer Term COVID-19 in Children and Young People (SPLaT-19 Cohort & Qualitative Study)

NCT05422937 | Completed

• 1 other identifier: RG-0348-22
• Study Type: observational
• Target: 502
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: While there is a substantial body of knowledge about acute Covid-19 in children and young people (CYP), less is known about long-COVID, where symptoms continue beyond four weeks, particularly since the most recent wave of the Omicron variant and the UK childhood vaccination programme roll out. This study aims to provide a picture of longer-term effects of an acute Covid-19 infection in CYP and identify their needs. Methods and analysis: The study comprises an observational prospective cohort study and a linked qualitative study. The cohort study will identify CYP aged 8-17 years in the West Midlands of England and, irrespective of Covid-19 status, invite them to complete an online questionnaire at point of recruitment, and after 3, 6, 9 and 12 months. CYP who have experienced long-term effects of COVID-19 will be invited to interview and, those who are currently experiencing symptoms, will be invited to record their experiences in a diary. Adults working in professional or third sector/voluntary roles with CYP will be invited to take part in a focus group to explore the perceived impact of Long-COVID on the wider experience of CYP. Approximately 900 participants will be needed for the cohort study to ensure the sample size is suitable, with approximately 20 CYP invited to interview and approximately 8 professionals invited to a focus group. Descriptive statistics will be used to describe incidence rates of symptoms and symptom resolution trajectories, and comparisons made between exposed and non-exposed groups. Logistic regression models will be used to estimate associations between candidate predictors and development of Long-COVID at each follow-up point. Linear regression will be used to estimate associations between candidate predictors and poor outcome in terms of health-related quality of life, as described by the KIDSCREEN10. Qualitative data will be analysed thematically using the constant comparison method. Ethics and dissemination: Research Ethics Committee and Health Research Authority approvals will be sought. Information about where to seek support will be provided to participants to mitigate against risks of harm. Study findings will be presented at conferences and published in open access journals.

Conditions

COVID-19; Pediatric ALL

Outcome Measures

Primary Outcomes (1)

• Screening For and Promotion of Health-Related Quality of Life in Children and Adolescents - a European Public Health perspective (KIDSCREEN, specifically using the KIDSCREEN 10 tool)

  Global health-related quality of life measure. Minimum value 1 and maximum value 5 per question. Higher values indicate better quality of life.

  12 months

Secondary Outcomes (4)

• Inventory of Long COVID symptoms

  12 months

• Health service utilisation

  12 months

• New medical conditions diagnosed since COVID

  12 months

• School absence and attainment

  12 months

Study Arms (1)

Children and Young People aged 8-17

All CYP aged 8 years - 17 years \& 11 months whether they have had acute COVID-19 or not. Exposure to COVID-19 will be defined as a self-reported positive Sars-CoV-2 PCR test OR a positive self-reported OR self-reported presumed COVID-19 illness. Participants must have a recorded mobile number in their GP record.

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All CYP aged 8 years - 17 years \& 11 months (inclusive), registered at a participating general practice, will be invited to participate, subject to the eligibility criteria.

You may qualify if:

• All CYP aged 8 years - 17 years \& 11 months will be eligible for the study regardless of whether they have had acute COVID-19 or not. Exposure to COVID-19 will be defined as a self-reported positive Sars-CoV-2 PCR test OR a positive self-reported LFD OR self-reported presumed COVID-19 illness. Participants must have a recorded mobile number in their GP record.

You may not qualify if:

• CYP aged 8-17 (inclusive) who have relevant dissent codes on their medical records, indicating that their records are not to be used for research. CYP who have declined consent for text messaging services will not be invited to the study. CYP younger than 8 years and older than 17 years and 11 months will not be invited to the study.
• Children and adolescents (n≈20) aged 8 to 17 years, with evidence of Long COVID, as identified through participation in SPLaT cohort and defined as symptoms persisting longer than 4 weeks following an acute episode of COVID-19.
• Adults working with children and adolescents in roles including teaching, social work, and voluntary organisations, identified by our local networks (n≈8).

Sponsors & Collaborators

• Keele University: lead

Study Sites (1)

Keele University

Newcastle-under-Lyme, Staffordshire, ST5 5BG, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Precursor Cell Lymphoblastic Leukemia-Lymphoma

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; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 21, 2022
• Study Start: October 19, 2022
• Primary Completion: March 2, 2024
• Study Completion: March 2, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)