A Novel method for assessing Infant Multiple Breath Washout (NIMBus)
Research type
Research Study
Full title
A Novel method for assessing Infant Multiple Breath Washout (NIMBus)
IRAS ID
179322
Contact name
Clare S Murray
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Cystic fibrosis (CF) is a genetic disorder characterised by, among other things, progressive lung damage. Despite early diagnosis (usually through newborn screening) and treatment there is evidence that children with CF have damage to their lungs by 1 year of age, despite no significant symptoms. Babies are unable to perform the standard lung function tests used in older patients. There is a need for non-invasive ways of looking for lung damage in infants, both to improve their clinical care and to aid in future research, as this group stands to benefit greatly from new treatments which are being developed for CF.
This study will assess a novel method of performing multiple breath washout (MBW) in infants. This can be used to assess lung clearance index (LCI), a lung function test which has been shown to be indicative of early lung damage in CF. The technology previously used to perform infant MBW was restricted to specialist research laboratories, and now is no longer manufactured.
A novel breathing circuit suitable for measuring LCI in infants under 2 years has been developed, and rigorously tested using a model lung. This pilot study will recruit infants with CF and healthy controls, and use this new method to measure their LCI. This involves a sleeping infant first breathing in a tracer gas through a facemask for a period of a few minutes, then breathing it out again; the expired gas is collected and analysed by a photoacoustic gas analyser (Innocor). Our primary goal will be to assess the feasibility of using the new method in infants. We will also look at the difference in LCI between children with CF and healthy controls, and compare the new method to the current gold standard of MBW measurement using a respiratory mass spectrometer.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
15/NW/0581
Date of REC Opinion
17 Aug 2015
REC opinion
Further Information Favourable Opinion