BronchiolitisNCT02881632
Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis
An observational study of Bronchiolitis, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 1 minute to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Structured Light Plethysmography (SLP) - Pneumscan
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy infants aged 0-2 years and Infants aged 0-1 years with Bronchiolitis
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
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
A cohort observational study to characterise baseline Structured Light Plethysmography (SLP) outputs in infants with bronchiolitis and examine response to treatment using the Thora3DiTM
Read the 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.
- Conditions
- Bronchiolitis
- Being tested
- Structured Light Plethysmography (SLP) - Pneumscan
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Light Plethysmography (SLP) - PneumscanDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Structured Light Plethysmography (SLP) - Pneumscan | |
| 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 Receives: Device: Structured Light Plethysmography (SLP) - Pneumscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured upto 7 days
Secondary outcomes (2)
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: Measured upto 7 days
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: Measured upto 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Pneumacare Ltd
- Responsible party
- Sponsor
- Investigators
- John Alexander, Principal investigator, UHNM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881632
- Sponsor's protocol ID
- 836
- Status last verified
- Aug 2016
- First submitted
- 28 Apr 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02881632
- Acronym / sponsor ID
- 836
- Conditions
- Bronchiolitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Collaborators
- Pneumacare Ltd
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy infants aged 0-2 | – | Device: Structured Light Plethysmography (SLP) - PneumscanHealthy 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 | – | Device: Structured Light Plethysmography (SLP) - PneumscanInfants 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 |
Who may qualify
- Ages
- 1 minute to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy infants aged 0-2 years and Infants aged 0-1 years with Bronchiolitis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Light Plethysmography (SLP) - PneumscanBoth 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. | Device | Healthy infants aged 0-2, Infants aged 0-1 with Bronchiolitis |
Primary outcome
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.
2 secondary outcomes
Changes in SLP measurements in infants during their clinical course.
Time frame: Measured upto 7 days
Changes in SLP measurements in infants given additional breathing support.
Time frame: Measured upto 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Bronchiolitis
Active, not recruiting
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Bronchiolitis
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
A New ECP Protocol for the Treatment of cGVHD
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Alexander principal investigator
UHNM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in SLP measurements between infants. (time frame: Measured upto 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.