STOP RSV
Research type
Research Study
Full title
Surveillance Towards Preventing Paediatric: incidence RSV attributable (LRTI) in Primary and Secondary/Tertiary Healthcare settings in Merseyside and Bristol, UK
IRAS ID
304483
Contact name
Andrea Collins
Contact email
Sponsor organisation
liverpool School of tropical medicine
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
Research Summary
Respiratory Syncytial Virus (RSV)is a seasonal respiratory virus that causes infection throughout life but is a significant contributor to childhood lower respiratory tract infections. RSV occurs in epidemics each winter in mild temperature climate countries like the UK. Many cases of bronchiolitis are mild and can be managed at home however this is a burden to families and primary care, as many as 10% also need hospital care. Approximately 10% of paediatric intensive care, admissions are due to RSV. In very young children, elderly people and those with weakened immune system RSV can result in severe illness or death. The main aim of this observational surveillance study is to assess the number of children with respiratory symptoms with laboratory confirmed Respiratory Syncytial Virus (RSV) swabs under 3 years age in Primary and Secondary/Tertiary healthcare settings in Merseyside and Bristol (United Kingdom). The study will also seek to determine the health economic burden to the family and health care.
These paediatric observational surveillance data aim to inform future vaccination strategies. At present there are no preventive therapies such as vaccines (passive or active) routinely available to young children in the national immunisation programme. In future these data may support the inclusion of preventive therapies as they become available.A minimum of 1800 children will be recruited into the study over a two year period. GPs, practice nurses, NHS research teams and hospital clinical staff will undertake screening for children <3 years when they attend as part of standard care for respiratory symptoms to determine whether they meet the inclusion criteria. If a swab has not already been taken for clinical care, a swab will be requested to be taken either by a researcher or at home by the parent. Parents or guardians of the participants will be asked to complete questionnaires at day 14 and day 28 relating to the impact and burden of infection upon the family in line with STOP RSV objectives.
Summary of Results
Between 10th December 2021 and 31st March 2023, 2074 participants were recruited to the study. 74 participants were withdrawn from the study after recruitment, consent was maintained to include the nasal swab data for 2 of these. 283 participants were recruited from primary care, 127 from walk in centres and 1,590 from secondary or tertiary care. Overall, 57% of participants were male, and 86.9% of participants were of White British ethnicity. 54% were 0-11 months old, 29% were 12-23 months and 17% were 24-35 months. 56% of parents completed the day 14 questionnaire and 53% completed the day 28 questionnaire.
Overall, 40% of participants had RSV detected on their nasal swabs. This varied according to hospital setting, age of participant, season and whether they had features of lower respiratory tract infection (a marker of more severe illness). The highest RSV rates were found in those admitted to hospital and in children under 1 year. Higher rates of RSV were seen in Summer and Autumn 2022.
It was common for participants with RSV to present multiple times to healthcare providers: for example 63% of RSV positive participants presenting to hospital had already had face to face contact with primary healthcare providers (such as General Practitioners or Walk in Centres). In addition, RSV positive participants who initially presented to primary care or the emergency department and were discharged from hospital, 7.5% were admitted at a later date. It was also common for participants to have prolonged respiratory symptoms, such as cough or snuffles, 80% had ongoing respiratory symptoms at 14 days after recruitment to the study and 39% at 28 days.
Underlying co-morbidity such as lung disease or heart disease, as well as being born premature, increased the risk of being admitted to hospital with RSV. However, when looking at the study population as a whole, the majority of participants who were admitted to hospital did not have any underlying co-morbidity and were not born premature (71%).
Overall, our data show a significant burden of RSV to patients and healthcare providers. It was common for patients to have prolonged respiratory symptoms and it was common for patients to present more than once to healthcare providers with the same illness. Currently licensed immunisation for RSV is targeted at children with significant co-morbidities or prematurity. However, our data suggests that a large burden to patients and healthcare providers of RSV is in children without any underlying co-morbidity. This suggests there may be a benefit to targeting newly licensed immunisations to all children under 1 year old regardless of whether they have a co-morbidity.
REC name
West of Scotland REC 4
REC reference
21/WS/0142
Date of REC Opinion
2 Dec 2021
REC opinion
Further Information Favourable Opinion