The RSV-SAM study
Research type
Research Study
Full title
The RSV-SAM Study: Validation of Nasal and Bronchial Absorption Sampling Methods for the Assessment of RSV Bronchiolitis in Infants
IRAS ID
188532
Contact name
Simon Nadel
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Every year Respiratory Syncytial Virus (RSV) infects 75% of all children under 1 year of age (infants). Approximately 1% of these get serious infections, affecting the lungs, causing bronchiolitis and pneumonia; about 1% of these infants will die from RSV infection.
Diagnosis of RSV is made by suctioning secretions from the nose of ill babies. However, this method may be unpleasant and does not allow for accurate measurement of the amount of virus present in the baby.
The reason why some babies get very ill with RSV is not known, but is related to the baby's response to the infection. Accurate measurement of the baby's inflammatory response to RSV infection is not accurate using secretions obtained by suctioning, as the mucus obtained is not a good marker or the baby's immune response.
In our proposed study we will compare a less invasive method of obtaining nasal secretions using a special absorbent filter paper (SAM). This will allow us to accurately measure amount of virus in the nose of infected babies, and to accurately measure markers of inflammation in the nose. We will compare this method to the standard method of obtaining secretions.
In babies who are very ill with RSV needing mechanical ventilation, we will use a specially adapted catheter with the same SAM paper integrated into it, which we will pass into the lungs of the baby to obtain measures of virus and inflammation, and compare that to what we find in the nose.
We do not expect to find any harmful effects from these methods, and they are accurate, this will be a better way of diagnosing RSV infection and the inflammatory response.
This will allow us to better understand the response to treatment of RSV infection which is being developed.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
15/WM/0343
Date of REC Opinion
3 Oct 2015
REC opinion
Favourable Opinion