Clinical trial · Interventional
Edinburgh and Lothian Virus Intervention Study in Kids
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
NCT03463694CI-TRIAL-00077287ELVIS KidscompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Upper Respiratory Tract Infections | — | UNRESOLVED | — |
| Virus | — | UNRESOLVED | — |
| Virus Shedding | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Na Cl solution | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypertonic Saline ~2.6% NaCl
- description
- 3 drops each nostril of Hypertonic Saline (HS) at least 4 times a day until asymptomatic or maximum of 28 days
- interventionNames
- Other: Na Cl solution
- type
- NO_INTERVENTION
- label
- Standard Care
- description
- Control arm of standard symptomatic care only
Primary outcomes (1)
- measure
- Time to the first report that the child is "not unwell".
- timeFrame
- Maximum of 28days
- description
- Time until child not unwell
Secondary outcomes (21)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Weeks
- Maximum age
- 7 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRamalingam S, Graham C, Oatey K, Rayson P, Stoddart A, Sheikh A, Cunningham S; ELVIS Kids Trial Investigators. Study protocol of the Edinburgh and Lothian Virus Intervention Study in Kids: a randomised controlled trial of hypertonic saline nose drops in children with upper respiratory tract infections (ELVIS Kids). BMJ Open. 2021 May 5;11(5):e049964. doi: 10.1136/bmjopen-2021-049964. PMID 33952557