Pediatric ALL Clinical Trial
— ELVIS KidsOfficial title:
Edinburgh and Lothian Virus Intervention Study in Kids (ELVIS Kids): A Randomised Controlled Trial of Hypertonic Saline Nose Drops in Children With Upper Respiratory Tract Infections
Verified date | May 2024 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 407 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Weeks to 7 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Childrens' Clinical Research Facility | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to the first report that the child is "not unwell". | Time until child not unwell | Maximum of 28days | |
Secondary | Severity of all symptoms | Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable | 1-28 days (or until child is well) | |
Secondary | The length of time for individual symptoms to resolve | Recorded as: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable | 1-28 days (or until child is well) | |
Secondary | Severity of individual symptoms | Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable | 1-28 days (or until child is well) | |
Secondary | Contacting healthcare (NHS 24, OOH, GP) -Number of participants | Number of participants | 1-28 days (or until child is well) | |
Secondary | Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts | Number of contacts | 1-28 days (or until child is well) | |
Secondary | Participants needing GP appointments- Number of participants | Number of appointments | 1-28 days (or until child is well) | |
Secondary | Participants needing GP appointments- Frequency of contacts | Number of appointments | 1-28 days (or until child is well) | |
Secondary | Number of participants attending hospital and diagnosis - Number of participants | Number of participants | 1-28 days (or until child is well) | |
Secondary | Number of participants attending hospital and diagnosis - Frequency of contacts | Number of attendances | 1-28 days (or until child is well) | |
Secondary | Length of stay in hospital if admitted | Length in Days | 1-28 days (or until child is well) | |
Secondary | Number of participants reporting wheeze during illness and between end of illness to 28 days | Number reporting wheeze | Day 28 | |
Secondary | Number of participants reporting over the counter medication use | Number of participants | 1-28 days (or until child is well) | |
Secondary | Duration of viral shedding | Viral shedding duration in days | Days 1-5 | |
Secondary | Reduction in viral shedding | Log conversion of each positive result will be done using the following formula: (40-CT of specimen)/3.3 to estimate change in shedding. | Days 1-5 | |
Secondary | Rate of reduction in viral shedding | Rate of viral shedding duration in days | Days 1-5 | |
Secondary | Reduction in transmission to household contacts | Questionnaire - reported number of adults and children catching URTI | 1-28 days (or until child is well) | |
Secondary | Number of participants reporting side effects of nasal drops | Side effects reported | 1-28 days (or until child is well) | |
Secondary | Types and severity of side effects reported | Side effects reported | 1-28 days (or until child is well) | |
Secondary | Number of days lost from school/nursery for child | Number of days | 1-28 days (or until child is well) | |
Secondary | Number of days lost from work for parent/guardian | Number of days | 1-28 days (or until child is well) | |
Secondary | Cost of over the counter medication used | Cost of medicine used. | 1-28 days (or until child is well) |
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