Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis
1 other identifier
observational
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 29, 2016
CompletedAugust 29, 2016
August 1, 2016
4 months
April 28, 2016
August 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Changes in SLP measurements in infants during their clinical course.
Measured upto 7 days
Changes in SLP measurements in infants given additional breathing support.
Measured upto 7 days
Study Arms (2)
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.
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
Interventions
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.
Eligibility Criteria
Healthy infants aged 0-2 years and Infants aged 0-1 years with Bronchiolitis
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospitals of North Midlands NHS Trustlead
- Pneumacare Ltdcollaborator
Study Sites (1)
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Alexander
UHNM
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2016
First Posted
August 29, 2016
Study Start
November 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
August 29, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share