Status:
COMPLETED
Edinburgh and Lothian Virus Intervention Study in Kids
Lead Sponsor:
University of Edinburgh
Conditions:
Upper Respiratory Tract Infections
Virus
Eligibility:
All Genders
40-7 years
Phase:
NA
Brief Summary
ELVIS Kids is a parallel, open label, randomised controlled trial (RCT) of Hypertonic Saline (HS) nose drops (\~2.6% NaCl) vs. standard care in children \<7 years of age with symptoms of an Upper Resp...
Detailed Description
The study will run over \~30 months. Children are recruited prior to, or within 48 hours of developing URTI symptoms by advertising in areas such as local schools, nurseries, health centres and workpl...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Children between corrected gestational age of ≥40 weeks and \<7 years of age
- 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
- Children needing immediate medical attention
- Children using saline drops/sprays at the time of randomisation
- 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)
- 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)
- Children being followed up for developmental delay
- Children receiving the nasal flu vaccine ≤14 days ago
- Children taking part in another interventional trial
- If parents/guardians indicating that they are unable to comply with the study protocol prior to randomisation
- If parents/guardians are unable to understand written or spoken English
- Children randomised to ELVIS KIDS on a previous episode of URTI
- Children with a concurrently participating sibling
Exclusion
Key Trial Info
Start Date :
November 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT03463694
Start Date
November 2 2018
End Date
September 30 2023
Last Update
May 17 2024
Active Locations (1)
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1
Childrens' Clinical Research Facility
Edinburgh, United Kingdom, EH9 1LF