Respiratory Failure Clinical Trial
— RSV-SAMOfficial title:
Validation of Nasal and Bronchial Absorption Sampling Methods for the Assessment of RSV Bronchiolitis in Babies and Children
Verified date | October 2019 |
Source | Imperial College Healthcare NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 152 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 2 Years |
Eligibility |
Group 1 and Group 2 Inclusion Criteria - Infants aged 2 weeks-24 months - Presentation to the Emergency Department with any upper respiratory tract infection (URTI) in the RSV season (Oct-March). OR • Documented RSV infection, admitted to the paediatric wards at St Mary's Hospital. Exclusion Criteria - Any local or systemic factor that would influence the safety of nasal sampling. - Bilateral indwelling nasal catheters or local nasal pathology preventing access for nasal sampling. - Bleeding disorders. - The baby is taking part in another interventional study. - The parents or guardians not able to sign the informed consent from due to limited English or comprehension despite the use of independent interpreter services. - Limited life expectancy of the baby, Group 3 Inclusion criteria - Hospitalised Infants admitted to the PICU at St. Mary's Hospital, aged 2 weeks-24 months with documented RSV infection (by rapid test and/or PCR). - Infants of weight >2kg. - On a conventional ventilator with an Endotracheal Tube (ETT) of >3.0mmm diameter Exclusion criteria - Any local or systemic factor that would influence the safety of nasal sampling. - Bilateral nasal catheters or local nasal pathology preventing access for nasal sampling. - The baby is taking part in another interventional study. - Prematurity - corrected gestational age <36 weeks, weight <2kg - Significant hypoxia or instability precluding ventilator disconnection - ETT < 3mm internal diameter - Transcutaneous oxygen saturation of <95% on 60% oxygen - Risk of bleeding - Pneumothorax - Infants receiving oral corticosteroid therapy at any time in past month - Parents or guardians not able to sign informed consent from due to limited English or understanding despite the use of independent interpreter services. - Limited life expectancy or a decision to limit management, Control Group 1 Inclusion criteria • Babies, aged 2 weeks-24 months, attending routine outpatient appointments or undergoing elective surgical procedures. Exclusion criteria - Any respiratory symptoms - All other exclusion are the same as Groups 1 and 2 Control Group 2 Inclusion criteria - Infants aged 2 weeks-24 months. - Infants ventilated on the PICU for any condition - Confirmed RSV negative by PCR of respiratory tract samples Exclusion Criteria - All exclusions are the same as Group 3 - In addition - any concern about raised intracranial pressure |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College NHS Healthcare Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College Healthcare NHS Trust | Pulmocide Ltd |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Throughout symptomatic respiratory infection, up to 1 month | |
Primary | 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). | Throughout symptomatic respiratory infection, up to 1 month | |
Primary | 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). | Throughout symptomatic respiratory infection, up to 1 month | |
Secondary | 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. | Throughout symptomatic respiratory infection, up to 1 month |
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