Evaluating the effects of two parental self-management eHealth applications on antibiotic use, number of primary care visits and gut microbiota of febrile Dutch children with acute, uncomplicated upper respiratory tract infections: a study protocol for a randomised controlled trial.

introductionPhase-specific fever management (ie, tailoring care to the rising, plateau and defevering stages of fever) and the cautious use of evidence-based natural medicinal products (NMPs, eg, herbal preparations with demonstrated evidence of safety and effectiveness) are hypothesised to reduce antibiotic (AB) use for acute, uncomplicated upper respiratory tract infections (URTIs). The objective of the trial is to investigate the effects of a parental phase-specific FeverApp and an NMP WebApp on AB use, the number of primary care visits and the gut microbiota of children with acute, uncomplicated URTIs. METHODS AND ANALYSES: The study design is a randomised controlled trial with three arms: a FeverApp group, an NMP WebApp group and a control group. Participants are parents of children aged 3 months to 12 years with fever (≥38°C) and symptoms of an acute, uncomplicated URTI. Parents (n=320) will complete a baseline questionnaire and collect a baseline stool sample from their child. The intervention groups then use one of the apps, and all parents report URTI symptoms of their child on days 2, 5 and 7. On day 10, they complete a follow-up questionnaire, and they collect a second stool sample from their child. The FeverApp contains evidence-based information about fever and how to manage it, tailored fever advice and an option to monitor a child's health status during a fever episode. The NMP WebApp is an evidence-based online decision-making tool that helps parents navigate the use of NMPs with reported safety and effectiveness for URTI symptoms. The primary endpoint is AB use, and secondary endpoints include recovery time, complications/adverse events, the number of primary care visits/telephone consultations and changes in gut microbiota composition. Participants were recruited nationwide (urban and rural) via online advertising and community flyers. ETHICS AND DISSEMINATION: A waiver was obtained from a recognised Institutional Review Board, participants signed for informed consent, and all data are pseudonymised and stored securely. Results will be published in scientific, peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT06140446 (www. CLINICALTRIALS: gov).