NCT03463694

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 40 Weeks – 7 Years
• Healthy volunteers: Accepted

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.

Conditions

• Upper Respiratory Tract Infections
• Virus
• Virus Shedding
• Pediatric ALL

Interventions

Type	Name	Description
OTHER	Na Cl solution	\~2.6% NaCl solution prepared from sea salt

Timeline

• Start date: 2018-11-02
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2018-03-13
• Last updated: 2024-05-17

Locations

1 site across 1 country: United Kingdom