An interventional study of Nasal and Bronchial Sampling in Bronchiolitis, Bronchiolitis, Viral and RSV Infection, sponsored by Imperial College Healthcare NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 2 Weeks to 2 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by Imperial College Healthcare NHS Trust · Not applicable, Interventional, and Diagnostic
This study will compare the novel methods of NS and BS with the standard technique of nasophayngeal aspiration (NPA) and routine ETT suction. We shall assess the samples for diagnosis of RSV, viral load and immune responses in the airways of babies with RSV infection. We shall also assess the genetics of babies included in this study, to see if they may be vulnerable to RSV infection.
In conjunction with a specialist medical device manufacturing company (Hunt Developments (Midhurst, West Sussex) we have produced novel nasosorption and bronchosorption kits that have CE marking. Both nasosorption and bronchosorption methods use synthetic absorptive matrix (SAM) strips: that look and feel like blotting paper, and will be placed onto the mucosal surface. These are comfortable to use and can be used at frequent intervals over extended periods of time. This non-invasive technique is ideal for infants and children, and it is possible to obtain neat mucosal lining fluid (MLF) even from normal healthy noses. The eluates contain cytokines and chemokines at high detectable levels on multiplex immunoassay.
We would like to use these SAMs to take MLF samples from the nasal and bronchial mucosal surfaces to see if these novel techniques can overcome the problems with current sampling methods. We plan to use these absorption techniques to measure RSV viral load. We also aim to look at the immune response in terms of the anti-viral interferon response (IFN-γ, IFN-λ, IFN-α2a, IP10, ITAC). In therapeutic studies in the future, it may be possible to document levels of drug (pharmacokinetics) in nasal MLF.
30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.
This study's enrollment of 152 is above the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.
Browse Bronchiolitis, Viral studies →Imperial College Healthcare NHS Trust is the lead sponsor of 80 studies on the registry; 19 are open to participants now.
Compared within Bronchiolitis, Viral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Bronchiolitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Group 1 and Group 2
Inclusion Criteria
OR • Documented RSV infection, admitted to the paediatric wards at St Mary's Hospital.
Exclusion Criteria
Group 3
Inclusion criteria
Exclusion criteria
Control Group 1 Inclusion criteria
Exclusion criteria
Control Group 2
Inclusion criteria
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Babies with suspected respiratory tract infection (RTI) in the ED
Diagnostic Test: Nasal and Bronchial Sampling
Babies with diagnosed RSV infection admitted to paediatric wards
Diagnostic Test: Nasal and Bronchial Sampling
Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation
Diagnostic Test: Nasal and Bronchial Sampling
Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures
Diagnostic Test: Nasal and Bronchial Sampling
Babies without RSV infection but requiring mechanical ventilation in PICU
Diagnostic Test: Nasal and Bronchial Sampling
Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.
The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling
To determine the difference in tolerability of nasosorption compared to NPA by assessment of acceptance by infants and families. Samples were collected from participants up to twice daily throughout study involvement, as such each participant could have \>1 sampling visits.
Time frame: Throughout symptomatic respiratory infection, up to 1 month
Accuracy of Nasosorption for Viral Load Measurement
To determine the difference in accuracy of nasosorption compared to NPA by assessment of level of viral load (measured by qPCR).
Time frame: Throughout symptomatic respiratory infection, up to 1 month
Accuracy of Bronchosorption for Viral Load Measurement, Compared to Tracheal Aspirate
To determine the difference in accuracy of bronchosorption (BSAM) compared to tracheal aspirate (TA) by assessment of level of viral load (measured by qPCR).
Time frame: Throughout symptomatic respiratory infection, up to 1 month
Immune Response
Establishing the use of nasal and bronchial sampling to measure the host immune response to RSV. We will determine cytokine and inflammatory mediator concentrations by immunoassay of eluted fluid from nasosorption and compare with NPA.
Time frame: Throughout symptomatic respiratory infection, up to 1 month
| Milestone | Emergency Department | Paediatric Wards | Paediatric Intensive Care | Health Controls | Controls in Paediatric Intensive Care |
|---|---|---|---|---|---|
| Started | 32 | 51 | 49 | 20 | 0 |
| Completed | 32 | 51 | 49 | 20 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
To determine the difference in tolerability of nasosorption compared to NPA by assessment of acceptance by infants and families. Samples were collected from participants up to twice daily throughout study involvement, as such each participant could have \>1 sampling visits.
| Sampling visits | Wards | Emergency Department |
|---|---|---|
| Nasosorption and NPA samples | 124 | 60 |
| NPA only | 0 | 0 |
| Discontinue sampling (while remaining in hospital) | 0 | 0 |
| Nasosorption only | 45 | 4 |
To determine the difference in accuracy of nasosorption compared to NPA by assessment of level of viral load (measured by qPCR).
| Spearman R score | All Participants |
|---|---|
| Accuracy of Nasosorption for Viral Load Measurement | 0.692 |
Establishing the use of nasal and bronchial sampling to measure the host immune response to RSV. We will determine cytokine and inflammatory mediator concentrations by immunoassay of eluted fluid from nasosorption and compare with NPA.
| Spearman R score | All Participants |
|---|---|
| Immune Response | 0.0001 |
To determine the difference in accuracy of bronchosorption (BSAM) compared to tracheal aspirate (TA) by assessment of level of viral load (measured by qPCR).
| Spearman R score | All Participants |
|---|---|
| Accuracy of Bronchosorption for Viral Load Measurement, Compared to Tracheal Aspirate | 0.45 |
Collected over Throughout participant hospitalisation, to a maximum of 6 months after the end of sampling. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Emergency Department | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Paediatric Wards | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Paediatric Intensive Care | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Health Controls | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Controls in Paediatric Intensive Care | — | — | — |
Controls in paediatric intensive care were sought but non recruited
| Age, Continuous(days) | Emergency Department | Paediatric Wards | Paediatric Intensive Care | Health Controls | Controls in Paediatric Intensive Care | Total |
|---|---|---|---|---|---|---|
| Mean | 212 (27 to 630) | 186 (23 to 571) | 168 (14 to 630) | 168 (33 to 313) | — | 176 (14 to 630) |
| Sex: Female, Male(Participants) | Emergency Department | Paediatric Wards | Paediatric Intensive Care | Health Controls | Controls in Paediatric Intensive Care | Total |
|---|---|---|---|---|---|---|
| Female | 9 | 22 | 15 | 7 | 0 | 53 |
| Male | 23 | 29 | 34 | 13 | 0 | 99 |
| Race (NIH/OMB)(Participants) | Emergency Department | Paediatric Wards | Paediatric Intensive Care | Health Controls | Controls in Paediatric Intensive Care | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | — | 0 |
| Asian | 4 | 12 | 5 | 2 | — | 23 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | — | 0 |
| Black or African American | 7 | 6 | 5 | 2 | — | 20 |
| White | 15 | 21 | 33 | 10 | — | 79 |
| More than one race | 6 | 12 | 6 | 6 | — | 30 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | — | 0 |
| Region of Enrollment(participants) | Emergency Department | Paediatric Wards | Paediatric Intensive Care | Health Controls | Controls in Paediatric Intensive Care | Total |
|---|---|---|---|---|---|---|
| United Kingdom | 32 | 51 | 49 | 20 | — | 152 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Participants consented that blood or nasal samples taken during this study can be used in the future for any ethically-approved studies.
Ran from Oct 2015 to primary completion in Jun 2018, 32 months.
Results were first posted in Nov 2019, 1 year 4 months after primary completion.
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Imperial College Healthcare NHS Trust