N/A
N=152
Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis
Bronchiolitis · Bronchiolitis, Viral · RSV Infection · Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT03062917 ↗Enrolled (actual)
152
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling — 124; 60; 0; 0 Sampling visits
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nasal and Bronchial Sampling (Diagnostic_test)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Imperial College Healthcare NHS Trust
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling |
124; 60; 0; 0; 0; 0 | — |
| PRIMARY Accuracy of Nasosorption for Viral Load Measurement |
0.692 | — |
| PRIMARY Accuracy of Bronchosorption for Viral Load Measurement, Compared to Tracheal Aspirate |
0.45 | — |
| SECONDARY Immune Response |
0.0001 | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT03062917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.