Trial Outcomes & Findings for Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis (NCT NCT03062917)

Last Updated: 2019-11-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

152 participants

Primary outcome timeframe

Throughout symptomatic respiratory infection, up to 1 month

Results posted on

2019-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Emergency Department Babies with suspected respiratory tract infection (RTI) in the ED Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.	Paediatric Wards Babies with diagnosed RSV infection admitted to paediatric wards Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.	Paediatric Intensive Care Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.	Health Controls Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.
Overall Study STARTED	32	51	49	20
Overall Study COMPLETED	32	51	49	20
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Emergency Department n=32 Participants Babies with suspected respiratory tract infection (RTI) in the ED Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.	Paediatric Wards n=51 Participants Babies with diagnosed RSV infection admitted to paediatric wards Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.	Paediatric Intensive Care n=49 Participants Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.	Health Controls n=20 Participants Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.	Controls in Paediatric Intensive Care Babies without RSV infection but requiring mechanical ventilation in PICU Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.	Total n=152 Participants Total of all reporting groups
Age, Continuous	212 days n=93 Participants	186 days n=4 Participants	168 days n=27 Participants	168 days n=483 Participants	—	176 days n=10 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	22 Participants n=4 Participants	15 Participants n=27 Participants	7 Participants n=483 Participants	0 Participants n=36 Participants	53 Participants n=10 Participants
Sex: Female, Male Male	23 Participants n=93 Participants	29 Participants n=4 Participants	34 Participants n=27 Participants	13 Participants n=483 Participants	0 Participants n=36 Participants	99 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	—	0 Participants n=10 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants	12 Participants n=4 Participants	5 Participants n=27 Participants	2 Participants n=483 Participants	—	23 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	—	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants	6 Participants n=4 Participants	5 Participants n=27 Participants	2 Participants n=483 Participants	—	20 Participants n=10 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants	21 Participants n=4 Participants	33 Participants n=27 Participants	10 Participants n=483 Participants	—	79 Participants n=10 Participants
Race (NIH/OMB) More than one race	6 Participants n=93 Participants	12 Participants n=4 Participants	6 Participants n=27 Participants	6 Participants n=483 Participants	—	30 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	—	0 Participants n=10 Participants
Region of Enrollment United Kingdom	32 participants n=93 Participants	51 participants n=4 Participants	49 participants n=27 Participants	20 participants n=483 Participants	—	152 participants n=10 Participants

PRIMARY outcome

Timeframe: Throughout symptomatic respiratory infection, up to 1 month

Population: Parents asked at each sampling timepoint on willingness to continue with respiratory sampling, as either: 1) both nasosorption and NPA, 2) just nasosorption, 3) just NPA, 4) discontinue sampling. This analysis includes all non-sedated hospitalised participants as sedation would influence the tolerability of sampling as perceived by parents/carers.

Outcome measures

Outcome measures
Measure	Wards n=169 Number of individual sampling visits None sedated participants recruited from general paediatric wards	Emergency Department n=64 Number of individual sampling visits Non-ventilated participants recruited from the emergency department
The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling Nasosorption and NPA samples	124 Sampling visits	60 Sampling visits
The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling NPA only	0 Sampling visits	0 Sampling visits
The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling Discontinue sampling (while remaining in hospital)	0 Sampling visits	0 Sampling visits
The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling Nasosorption only	45 Sampling visits	4 Sampling visits

PRIMARY outcome

Timeframe: Throughout symptomatic respiratory infection, up to 1 month

Population: Spearman R score correlation between RSV viral load as measured by nasosorption and NPA. This analysis includes all RSV+ infants independent of recruitment group as no differences in correlation between sample type were anticipated between recruitment group.

To determine the difference in accuracy of nasosorption compared to NPA by assessment of level of viral load (measured by qPCR).

Outcome measures

Outcome measures
Measure	Wards n=44 Number matched RSV+ nasosorption and NPA None sedated participants recruited from general paediatric wards	Emergency Department Non-ventilated participants recruited from the emergency department
Accuracy of Nasosorption for Viral Load Measurement	0.692 Spearman R score	—

PRIMARY outcome

Timeframe: Throughout symptomatic respiratory infection, up to 1 month

Population: Spearman R score correlation between RSV viral load as measured by bronchosorption and tracheal aspiration. This analysis includes all RSV+ infants independent of recruitment group as no differences in correlation between sample type were anticipated between recruitment group.

To determine the difference in accuracy of bronchosorption (BSAM) compared to tracheal aspirate (TA) by assessment of level of viral load (measured by qPCR).

Outcome measures

Outcome measures
Measure	Wards n=20 Number matched RSV+ BSAM and TA None sedated participants recruited from general paediatric wards	Emergency Department Non-ventilated participants recruited from the emergency department
Accuracy of Bronchosorption for Viral Load Measurement, Compared to Tracheal Aspirate	0.45 Spearman R score	—

SECONDARY outcome

Timeframe: Throughout symptomatic respiratory infection, up to 1 month

Population: Spearman R score correlation of Interferon-gamma levels in matched nasosorption and NPA samples from any participant. This analysis includes all RSV+ infants independent of recruitment group as no differences in correlation between sample type were anticipated between recruitment group.

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.