A single centre randomised, feasibility study using point-of-care (POC) testing for respiratory viruses to direct oral corticosteroids use in preschool-aged children with acute wheeze. A Protocol
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Background
Wheezing in the pre-school aged group (under 5 years) is a common presentation and significant healthcare burden. It is a heterogenous presentation representing a spectrum of phenotypes and although the causes may be multifactorial, viral infection is the most common trigger, with rhinovirus and Respiratory Syncytial Virus (RSV) being the most commonly detected. Rigorous evidence-based guidance for the acute management of preschool wheeze (PW) with respect to which children likely to benefit from oral corticosteroid therapy (OCS), is lacking. RCTs of OCS use in PW have not adequately assessed the impact of respiratory virus testing in the management of PW. To address the hypothesis that OCS response may be determined by the specific virus, the feasibility of performing POC respiratory virus tests prior to randomisation in an acute paediatric ED setting needs to be ascertained.
Methods
The PRECISE Study will be a single centre, randomised, open-label, feasibility trial. Children aged 24-59 months with acute wheeze will be eligible if the clinician is uncertain if there is a role for oral corticosteroid therapy or not. At enrolment, participants will undergo a nasal swab for rapid respiratory virus testing. Children will be randomised in a 1:1 ratio to receive oral dexamethasone or not, based on their RSV result. Participants will continue to be managed by the clinician according to local guidance. They will be invited for clinical review at 72 hours where a repeat nasal swab may be performed. There will be a telephone follow up at one month and parents will be invited for extended telephone interviews within a further month. Comprehensive screening logs will address the primary outcome of recruitment and timeliness until enrolment. Remaining timeliness and adherence outcomes will be recorded in individual participant records and described using CONSORT diagrams. Acceptability will be measured using a mixed method qualitative approach based on the theory of acceptability framework.
Discussion
This pragmatically designed trial will address key feasibility points needed to inform a future, definitive multi-centre RCT prospectively testing the role of respiratory virus testing to randomise children with PW to receive oral corticosteroids or not.
Trial registration
NCT06580600 ( clinicaltrials.gov )
