NCT03463694

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
407

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

November 2, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

4.9 years

First QC Date

February 14, 2018

Last Update Submit

May 16, 2024

Conditions

Upper Respiratory Tract InfectionsVirusVirus SheddingPediatric ALL

Outcome Measures

Primary Outcomes (1)

  • Time to the first report that the child is "not unwell".

    Time until child not unwell

    Maximum of 28days

Secondary Outcomes (21)

  • Severity of all symptoms

    1-28 days (or until child is well)

  • The length of time for individual symptoms to resolve

    1-28 days (or until child is well)

  • Severity of individual symptoms

    1-28 days (or until child is well)

  • Contacting healthcare (NHS 24, OOH, GP) -Number of participants

    1-28 days (or until child is well)

  • Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts

    1-28 days (or until child is well)

  • +16 more secondary outcomes

Study Arms (2)

Hypertonic Saline ~2.6% NaCl

EXPERIMENTAL

3 drops each nostril of Hypertonic Saline (HS) at least 4 times a day until asymptomatic or maximum of 28 days

Other: Na Cl solution

Standard Care

NO INTERVENTION

Control arm of standard symptomatic care only

Interventions

Na Cl solutionOTHER

\~2.6% NaCl solution prepared from sea salt

Hypertonic Saline ~2.6% NaCl

Eligibility Criteria

Age40 Weeks - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens' Clinical Research Facility

Edinburgh, EH9 1LF, United Kingdom

Location

Related Publications (1)

  • Ramalingam 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: 33952557DERIVED

MeSH Terms

Conditions

Respiratory Tract InfectionsVirus DiseasesPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Sandeep Ramalingham

    NHS Lothian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The team in the virology lab carrying out the analysis of the nasal swabs will be blinded to the allocation of the participant.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: ELVIS Kids is a parallel, open label, randomised controlled trial (RCT) of HS nose drops (\~2.6% NaCl) vs. standard care in children \<7 years of age with symptoms of an URTI.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2018

First Posted

March 13, 2018

Study Start

November 2, 2018

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations

GB(1)