Evaluation of the diagnostic capacities of saliva sampling from pediatric patients: Protocol for a randomized intra-individual study.

Acute bronchiolitis is a common respiratory infection that affects approximately 30% of children under two years of age in France. While most cases are mild and treated on an outpatient basis, around 0.5% of children require hospitalization for monitoring and/or treatment. This condition, which is linked to various respiratory pathogens, accounts for a significant proportion of winter activity in hospital pediatric departments. Diagnosis for young children under two years of age is currently based on nasopharyngeal aspiration (NPA), performed by nurses on medical prescription. Although considered the gold standard, this technique is invasive and potentially traumatic for children. It often requires several caregivers and sometimes causes tension with families. The experience of the SARS-CoV-2 pandemic has highlighted the value of saliva sampling, with good diagnostic concordance with reference methods, as well as better tolerance and acceptability than nasopharyngeal swabbing in children over 2 years of age. In this context, our study aims to compare NPA and saliva sampling in the diagnosis of respiratory distress in children between 28 days and 2 years of age, to evaluate the concordance of results, and to compare tolerance and acceptability. Clinical trial number: NCT07350291.