NCT07350291

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 502 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 28 Days – 23 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pediatrics
• Virus Diseases in Children

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	The aim is to compare the effectiveness of virological and bacterial detection between two sampling methods	The nasopharyngeal swab and the buccal swab will be taken separately as a cross over with randomisation carried out to allow a different order for each patient. The collection time, the quantity of virus, the quality of the sample and the human intervention will be quantified.The pain and comfort of both carers and children will be assessed.

Timeline

• Start date: 2026-09-01
• Primary completion: 2029-12-31
• Completion: 2030-07-01
• First posted: 2026-01-20
• Last updated: 2026-01-20