Edinburgh and Lothian Virus Intervention Study in Kids
- Conditions
- Upper Respiratory Tract InfectionsVirusVirus SheddingPediatric ALL
- Interventions
- Other: Na Cl solution
- Registration Number
- NCT03463694
- Lead Sponsor
- University of Edinburgh
- 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 Respiratory Tract Infection (URTI).
- 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 workplaces as well as social media. For the purposes of this study an URTI is defined as: at least two respiratory symptoms (nasal stuffiness, runny nose, cough, sore throat, or sneezing) OR one respiratory symptoms and at least one systemic symptom (lethargy, muscle pain, headache, pyrexia ≥38°C).
Willing parents/guardians, of children \<7 years of age, will be directed by the study advertising to contact the research team at their local research site if they are interested in participating. Children will be randomised to either a Control arm of standard symptomatic care, or an Intervention arm of 3 drops each nostril of HS at least 4 times a day until 24 hours after asymptomatic or maximum of 28 days. All participants will be requested to obtain a mid-turbinate nasal swab prior to first nasal HS drops (repeated daily for 5 days), a daily symptom diary (CARIFS, a valid illness measure in the UK), and an end of illness questionnaire (healthcare use, adverse events, acceptability, infection in household contacts, parental time taken off usual activities). Parent/guardian of the children allocated to the intervention arm will be taught how to prepare the HS. Parent/guardian of children who are asymptomatic at recruitment are requested to inform CCRF when the child develops an URTI (within 48 hours) and follow the instructions already provided to them when given the go-ahead to start the trial. On day 28, parents/guardians will be contacted to determine if their child suffered from wheeze either during the illness or at any point until day 28. Participation in the study will end on day 28.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 407
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypertonic Saline ~2.6% NaCl Na Cl solution 3 drops each nostril of Hypertonic Saline (HS) at least 4 times a day until asymptomatic or maximum of 28 days
- Primary Outcome Measures
Name Time Method Time to the first report that the child is "not unwell". Maximum of 28days Time until child not unwell
- Secondary Outcome Measures
Name Time Method The length of time for individual symptoms to resolve 1-28 days (or until child is well) Recorded as: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable
Contacting healthcare (NHS 24, OOH, GP) -Number of participants 1-28 days (or until child is well) Number of participants
Severity of all symptoms 1-28 days (or until child is well) Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable
Severity of individual symptoms 1-28 days (or until child is well) Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable
Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts 1-28 days (or until child is well) Number of contacts
Participants needing GP appointments- Number of participants 1-28 days (or until child is well) Number of appointments
Participants needing GP appointments- Frequency of contacts 1-28 days (or until child is well) Number of appointments
Number of participants attending hospital and diagnosis - Frequency of contacts 1-28 days (or until child is well) Number of attendances
Length of stay in hospital if admitted 1-28 days (or until child is well) Length in Days
Number of participants attending hospital and diagnosis - Number of participants 1-28 days (or until child is well) Number of participants
Duration of viral shedding Days 1-5 Viral shedding duration in days
Reduction in viral shedding Days 1-5 Log conversion of each positive result will be done using the following formula: (40-CT of specimen)/3.3 to estimate change in shedding.
Number of participants reporting wheeze during illness and between end of illness to 28 days Day 28 Number reporting wheeze
Number of participants reporting over the counter medication use 1-28 days (or until child is well) Number of participants
Rate of reduction in viral shedding Days 1-5 Rate of viral shedding duration in days
Reduction in transmission to household contacts 1-28 days (or until child is well) Questionnaire - reported number of adults and children catching URTI
Number of participants reporting side effects of nasal drops 1-28 days (or until child is well) Side effects reported
Types and severity of side effects reported 1-28 days (or until child is well) Side effects reported
Number of days lost from school/nursery for child 1-28 days (or until child is well) Number of days
Number of days lost from work for parent/guardian 1-28 days (or until child is well) Number of days
Cost of over the counter medication used 1-28 days (or until child is well) Cost of medicine used.
Trial Locations
- Locations (1)
Childrens' Clinical Research Facility
🇬🇧Edinburgh, United Kingdom