Clinical trial NCT02881632: Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis
Official title: Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis: Validation of Structured Light Plethysmography (SLP) in Healthy Infants and in Infants With Clinical Bronchiolitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiolitis
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
Collaborators: name: Pneumacare Ltd
First posted: 2016-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy infants aged 0-2 years and Infants aged 0-1 years with Bronchiolitis

Brief summary: A cohort observational study to characterise baseline Structured Light Plethysmography (SLP) outputs in infants with bronchiolitis and examine response to treatment using the Thora3DiTM

Detailed description: Viral illness, particularly chest infection causing breathing difficulty in infants and children is the commonest reason for admission to hospital. At present, there are no objective measurements of the degree of breathing difficulty.

This is because current objective tests of breathing difficulty requires the patient to cooperate and actively perform the tests. This is not possible in babies and very challenging in young children. SLP is a noncontact, effort independent technique for measuring the rate of breathing, the amount of chest expansion and the relative contribution of chest and abdomen to the work of breathing. Measuring these parameters which are known to vary with increasing breathing difficulty will allow us to make objective assessments of breathing difficulty. This study proposes to validate this technique in babies aged 02 years who are healthy and in babies with clinical viral bronchiolitis. The Investigators intend to demonstrate that the technique is feasible in this young age group and that the investigators will be able to demonstrate clinically valid differences between normal and ill babies and also demonstrate measurable differences with the evolution of the clinical illness.

Eligibility criteria: Inclusion Criteria

* Aged between 0 and 1 years
* Doctor diagnosis of AVB
* Admitted to hospital within last 24hrs (AVB participants only)
* Or healthy term infant aged up to 2yrs with no current respiratory illness

Exclusion Criteria:

* Patients with significant co morbidities resulting in clinical instability (assessed by the clinician at screening only):
* An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study
* Parents unable to consent/comply with trial protocol
* An inpatient for over 24hrs (AVB patients only)

Primary outcomes:
measure: Difference in SLP measurements between infants.
timeFrame: Measured upto 7 days
Secondary outcomes:
measure: Changes in SLP measurements in infants during their clinical course.
timeFrame: Measured upto 7 days
measure: Changes in SLP measurements in infants given additional breathing support.
timeFrame: Measured upto 7 days
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
state: Staffordshire
Study officials:
affiliation: UHNM
name: John Alexander
role: PRINCIPAL_INVESTIGATOR
References: