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Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02881632
First Posted: August 29, 2016
Last Update Posted: August 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pneumacare Ltd
Information provided by (Responsible Party):
University Hospitals of North Midlands NHS Trust
  Purpose
A cohort observational study to characterise baseline Structured Light Plethysmography (SLP) outputs in infants with bronchiolitis and examine response to treatment using the Thora3DiTM

Condition Intervention
Bronchiolitis Device: Structured Light Plethysmography (SLP) - Pneumscan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by University Hospitals of North Midlands NHS Trust:

Primary Outcome Measures:
  • Difference in SLP measurements between infants. [ Time Frame: Measured upto 7 days ]
    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.


Secondary Outcome Measures:
  • Changes in SLP measurements in infants during their clinical course. [ Time Frame: Measured upto 7 days ]
    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

  • Changes in SLP measurements in infants given additional breathing support. [ Time Frame: Measured upto 7 days ]
    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.


Enrollment: 60
Study Start Date: November 2015
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy infants aged 0-2
Healthy infants aged 0-2 year with no respiratory diseases to provide a reference values. A structured light pattern (Structured Light Plethysmography (SLP) - Pneumscan) will be projected onto the chest and abdominal wall and the movement of this pattern as the patient breathes will be recorded for 2 min. The total period of testing per session should take approximately 30 minutes per person.
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.
Infants aged 0-1 with Bronchiolitis
Infants admitted to hospital within last 24hrs (AVB participants only). A structured light pattern (Structured Light Plethysmography (SLP) - Pneumscan) will be projected onto the chest and abdominal wall and the movement of this pattern as the patient breathes will be recorded for 2 min. The total period of testing per session should take approximately 30 minutes per person
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy infants aged 0-2 years and Infants aged 0-1 years with Bronchiolitis
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881632


Locations
United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Sponsors and Collaborators
University Hospitals of North Midlands NHS Trust
Pneumacare Ltd
Investigators
Principal Investigator: John Alexander UHNM
  More Information

Responsible Party: University Hospitals of North Midlands NHS Trust
ClinicalTrials.gov Identifier: NCT02881632     History of Changes
Other Study ID Numbers: 836
First Submitted: April 28, 2016
First Posted: August 29, 2016
Last Update Posted: August 29, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections