Evaluation of the Diagnostic Capabilities of Saliva Samples From Pediatric Patients, Promoting Active Involvement of the Individuals Concerned and Their Families.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The aim is to compare the effectiveness of virological and bacterial detection between two sampling methods.
- Who it may be relevant to
- Registry conditions: Pediatrics, Virus Diseases in Children. Basic parameters: 28 Days — 23 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Interventions
- 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.
Primary outcome measures
- Number of patient with a detection of respiratory pathogens [Time frame: Day 1]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Devienne L, Goram L, Morton-Fauche C, Foucher Y, Pelras A, Leveque N, Binet A, Bouchet C, Pitard C, Beaumatin G, Deroche L. Evaluation of the diagnostic capacities of saliva sampling from pediatric patients: Protocol for a randomized intra-individual study. MethodsX. 2026 Jul 8;17:104038. doi: 10.1016/j.mex.2026.104038. eCollection 2026 Dec. PMID 42502776
Identifiers
NCT: NCT07350291 · Presap · PHRIP