CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
3% hypertonic salinedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01469845
NCT01469845Phase 3Completed

Hypertonic Saline in Acute Bronchiolitis: Randomised Controlled Trial and Economic Evaluation

Sheffield Children's NHS Foundation Trust·interventional·Posted Nov 10, 2011·Updated Mar 25, 2015

In Brief

A Phase 3 clinical trial evaluating 3% hypertonic saline for Acute Bronchiolitis. Completed, enrolled 300 participants across 9 sites.

Detailed Summary

Acute bronchiolitis is a common, distressing illness affecting children. A virus infects the lungs, and then the airways become blocked, leading to difficulties with breathing. It is the most common reason why children are admitted to hospital, with 1-3% of all children admitted to hospital during their first winter, creating enormous strains on NHS services. The majority of those admitted with the condition are under six months of age and the associated stress for parents is considerable. After forty years of research the best treatment we have is supportive care and oxygen. Recent research suggests that salt water, sprayed as a mist so that the children can breathe it in ('nebulised 3% hypertonic saline') might help children with acute bronchiolitis. Scientists think that the salt water changes the mucus which blocks the airways so that it can be cleared more easily. Three small research studies all suggested that a child's time in hospital could be reduced by a quarter by using this treatment. If this was true, it would be good for children, their families and the children's wards trying to cope with the large numbers admitted with bronchiolitis every year. To decide whether this treatment should be used throughout the NHS, we need to run a randomised controlled trial of hypertonic saline in a large number of children. The trial will tell us if adding saline to usual care reduces distress in both children and parents, as well as whether it reduces the length of time they stay in hospital. We will then know if the treatment is the best thing for children with bronchiolitis and whether it provides the NHS with good value for money.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.6 years ago

Interventions

3% hypertonic salinedevice

4 ml dose to be administered every 6 hours