Evaluation of the Diagnostic Capabilities of Saliva Samples From Pediatric Patients, Promoting Active Involvement of the Individuals Concerned and Their Families.

Evaluation of the Diagnostic Capabilities of Saliva Samples From Pediatric Patients, Promoting Active Involvement of the Individuals Concerned and Their Families: Protocol for a Randomized Intra-individual Study.

The management of respiratory infections accounts for a large proportion of winter activity in paediatric wards. The main pathologies are bronchiolitis, affecting infants under the age of 2. Today, the reference method for diagnosing respiratory pathogen infections is nasopharyngeal aspirate (NPA), performed by paramedical staff. However, this technique is invasive and traumatic for paediatric patients. During the SARS-CoV-2 pandemic, salivary sampling was used on a large scale in the paediatric population, and showed good concordance with reference samples, as well as better tolerance/acceptability. The aim of the PreSaP (Paediatric Saliva Sampling) study is to assess the diagnostic capabilities of saliva samples¹ . This will be a monocentric, intra-individual, randomised study involving 502 children using the results of nasopharyngeal aspirates as the gold standard. We will also evaluate the time required to take nasopharyngeal aspirates and saliva samples in order to examine any difficulties associated with the two sampling methods. Although the results of our study report few diagnostic errors, they would justify the use of saliva sampling in routine care to reduce stressful and painful factors, and thus contribute to the well-being of infants and children. Saliva sampling could improve acceptance by the child and those around him, avoiding a less negative experience while guaranteeing a reliable diagnosis of respiratory pathogens. This new technique should also encourage the active involvement of all those involved in care.

Inclusion Criteria:

• Infants aged between 28 days and under 24 months.

  • Admission to paediatric A&E or general paediatrics.
  • Respiratory conditions requiring treatment for microbiological diagnosis by upper airway sampling.
  • Collection of consent signed by legal representatives or guardians with parental authority. Except in cases where there is a single parent with parental authority.
  • Persons affiliated with or beneficiaries of a social security scheme.

Exclusion Criteria:• Refusal to participate by one of the legal representatives or the patient.

• Patients with a contraindication to ASNA (those with haemophilia, on anticoagulants or with thrombocytopenia).
• Patients with a known increased risk of epistaxis (nosebleeds), hypertrophic rhinitis or other conditions causing excessive mucosal fragility.
• Participation in another study that would impact the primary objective of this research.
• Patients who may be allergic to the material used in the sponge pacifier.
• Patients in a life-threatening emergency situation.