Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT03463694
Eligibility Criteria:
INCLUSION CRITERIA
1. Children between corrected gestational age of ≥40 weeks and \<7 years of age
2. Children without URTI OR ≤48 hours of URTI\* starting.
* A URTI being defined as at least two respiratory symptoms (nasal congestion (i.e. stuffy nose), runny nose, cough, sore throat) OR one respiratory symptom + at least one systemic symptom (Low energy/tired, muscle aches/pains, headache, fever ≥38°C).
EXCLUSION CRITERIA
1. Children needing immediate medical attention
2. Children using saline drops/sprays at the time of randomisation
3. Children on immunosuppressive medication, regular oral/inhaled steroids, regular antibiotics (use of antibiotics is allowed as long as the child does not need regular antibiotics)
4. Children with a known chronic illness (e.g. cystic fibrosis, cardiac, renal, liver, lung, neurological conditions) apart from wheeze or asthma which are not exclusions if the child is otherwise well and not on regular steroids)
5. Children being followed up for developmental delay
6. Children receiving the nasal flu vaccine ≤14 days ago
7. Children taking part in another interventional trial
8. If parents/guardians indicating that they are unable to comply with the study protocol prior to randomisation
9. If parents/guardians are unable to understand written or spoken English
10. Children randomised to ELVIS KIDS on a previous episode of URTI
11. Children with a concurrently participating sibling
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Weeks
Maximum Age:
7 Years
Study:
NCT03463694
Study Brief:
Protocol Section:
NCT03463694