Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis

Bronchiolitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881632
• Other study ID #: 836
• Status: Completed
• Phase: N/A
• First received: April 28, 2016
• Last updated: August 23, 2016
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: University Hospitals of North Midlands NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Device:
• Structured Light Plethysmography (SLP) - Pneumscan
Both healthy infants and bronchiolitis infants will have their chest movements monitored using Structured Light Plethysmography (SLP) performed by a device (Thora-3 Di) using a projector and two cameras. A light pattern of black and white squares is projected on the child's chest and the cameras record how the shape of this pattern changes with breathing. A computer converts this information to show how the child's chest moves during breathing.

Locations

Country	Name	City	State
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent	Staffordshire

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals of North Midlands NHS Trust	Pneumacare Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in SLP measurements between infants.	Difference in SLP measurements between infants. SLP provides a measure of the chest and abdominal movement (Respiratory effort) of the subjects, the movement signal will be used to quantify clinically relevant tidal breathing parameters such as timing indices: Ti (Time of inspiration), Te ( Time of expiration) and Ttot (Ti+Te). Parameters will be quantified for each recorded SLP signal (averaged) from each infant, and then used to compare between infants with bronchiolitis and healthy babies.	Measured upto 7 days	No
Secondary	Changes in SLP measurements in infants during their clinical course.	Changes in SLP measurements in infants during their clinical course in hospital. SLP provides a measure of the chest and abdominal movement (Respiratory effort) of the subjects, the movement signal will be used to quantify clinically relevant tidal breathing parameters such as timing indices: Ti (Time of inspiration), Te ( Time of expiration) and Ttot (Ti+Te). For each subject SLP was recorded on a daily basis, this will allow the comparison between the parameters within subject to check the progression of the disease with time	Measured upto 7 days	No
Secondary	Changes in SLP measurements in infants given additional breathing support.	Changes in SLP measurements in infants during their clinical course in hospital who are given additional breathing support. SLP provides a measure of the chest and abdominal movement (Respiratory effort) of the subjects, the movement signal will be used to quantify clinically relevant tidal breathing parameters such as timing indices: Ti (Time of inspiration), Te ( Time of expiration) and Ttot (Ti+Te). For each subject SLP was recorded on a daily basis, this will allow the comparison between the parameters within subject to check the progression of the disease with time.	Measured upto 7 days	No