Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis (RSV-SAM)
Bronchiolitis, Bronchiolitis, Viral, RSV Infection
About this trial
This is an interventional diagnostic trial for Bronchiolitis
Eligibility Criteria
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
Sites / Locations
- Imperial College NHS Healthcare Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Other
Other
Other
Other
Other
Emergency Department
Paediatric Wards
Paediatric Intensive Care
Health Controls
Controls in Paediatric Intensive Care
Babies with suspected respiratory tract infection (RTI) in the ED
Babies with diagnosed RSV infection admitted to paediatric wards
Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation
Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures
Babies without RSV infection but requiring mechanical ventilation in PICU