Pneumonia in ChildrenNCT02941237
Development of a Robust and Reliable Pulse Oximeter for Children With Pneumonia in Low-income Countries
A study testing Pulse oximeter in people with Pneumonia in Children and Measurement of Peripheral Oxygen Saturation, run by The Lifebox Foundation at 3 sites in 3 countries.
Trial summary
This study is to test the usability of a new pulse oximeter probe designed for children 0-5 years. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia in Children, Measurement of Peripheral Oxygen Saturation
- What is being tested?
- Pulse oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 2 May 2017to 1 Jun 2018
- Phase
- Interventional
- 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 Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient participants:
- Inpatients (or child awaiting surgery on pre-operative ward) in Great Ormond Street Hospital, or government facilities in Malawi and Bangladesh
- Aged 0 - 59 months
- Clinically stable (as judged by the ward sister and medical team)
- Parent (or adult with parental responsibility) present
- Informed consent from the parent (or adult with parental responsibility)
Show all 9Show fewer
- Healthcare worker participants:
- Nursing staff employed at Great Ormond Street Hospital who are trained in the use of pulse oximetry or government healthcare providers working in Malawi and Bangladesh
- Written informed consent from the healthcare worker
Who cannot join
- Patient participants:
- Unstable or critically unwell patients (as judged by their medical team)
- Parents (or adult with parental responsibility) who are not able or willing to give informed consent
- Parents (or adult with parental responsibility) unable to speak English well enough to understand study methods or consent form (UK only)
- For part of the study assessing usability of the probe by healthcare workers, patients with oxygen saturation 95% or below will be excluded
- Healthcare worker participants:
- Healthcare providers who are not trained to use a pulse oximeter
- Healthcare providers who have not given written informed consent
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
Great Ormond Street Hospital NHS Foundation Trust
London, WC1N 3JH
About this study
Official title: Development of a Robust and Reliable Pulse Oximeter for Use by Frontline Healthcare Providers Caring for Children With Pneumonia in Low-income Countries
This study is to test the usability of a new pulse oximeter probe designed for children 0-5 years.
Read the detailed description
Pneumonia is the leading infectious cause of death in children under five. World Health Organization guidelines recommend measurement of peripheral oxygen saturation (SpO2) in children with pneumonia to guide treatment. This project focuses on the design of a new 'Lifebox' pulse oximeter probe for use in children 0-5 years of age.
A new oximeter probe compatible with the Lifebox oximeter has been designed to be used for children 0-5 years in all settings.
The aims of the study are to:
- to evaluate the usability of the redesigned Lifebox oximeter probe by an expert user
- to evaluate the usability of the redesigned oximeter probe by trained healthcare workers, against defined product specifications.
- to compare the usability of the redesigned oximeter probe to a market leading probe
- Being tested
- Pulse oximeter
- Keywords
- Pulse oximetry, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeterDevice
Time taken to measure oxygen saturation.
Completion of usability questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Healthcare worker measurement of SpO2 | Other | Measurement of SpO2 using the Lifebox pulse oximeter probe in children of different ages, stratified by age: 0-1 months, 2-11 months, 12-23 months and 24-59 months Receives: Device: Pulse oximeter |
| Expert measurement of SpO2 | Other | Measurement of SpO2 using the Lifebox pulse oximeter probe and Masimo oximeter probe in children of different ages, stratified by age: 0-1 months, 2-11 months, 12-23 months and 24-59 months Receives: Device: Pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to obtain SpO2 reading
The time to obtain a stable reading will be declared by the healthcare worker or expert and noted by the independent observer, to give a proportion fulfilling the Target Product Profile (TPP).
Measured: Through completion of study, average one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start2 May 2017
- Primary completion2 Jun 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pneumonia in ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Lifebox Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University College, London, PACHI Malawi - Parent and Child Health Initiative Trust, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Isabeau Walker, The Lifebox Foundation
- Investigators
- Isabeau A Walker, FRCA, Principal investigator, Great Ormond Street Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941237
- Sponsor's protocol ID
- OPP1133291
- Status last verified
- Mar 2023
- First submitted
- 16 Oct 2016
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burn SL, Chilton PJ, Gawande AA, Lilford RJ. Peri-operative pulse oximetry in low-income countries: a cost-effectiveness analysis. Bull World Health Organ. 2014 Dec 1;92(12):858-67. doi: 10.2471/BLT.14.137315. Epub 2014 Sep 24.
PubMed 25552770Finch LC, Kim RY, Ttendo S, Kiwanuka JK, Walker IA, Wilson IH, Weiser TG, Berry WR, Gawande AA. Evaluation of a large-scale donation of Lifebox pulse oximeters to non-physician anaesthetists in Uganda. Anaesthesia. 2014 May;69(5):445-51. doi: 10.1111/anae.12632.
PubMed 24738801Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.
PubMed 25280870Duke T, Wandi F, Jonathan M, Matai S, Kaupa M, Saavu M, Subhi R, Peel D. Improved oxygen systems for childhood pneumonia: a multihospital effectiveness study in Papua New Guinea. Lancet. 2008 Oct 11;372(9646):1328-33. doi: 10.1016/S0140-6736(08)61164-2. Epub 2008 Aug 15.
PubMed 18708248Bhutta ZA, Das JK, Walker N, Rizvi A, Campbell H, Rudan I, Black RE; Lancet Diarrhoea and Pneumonia Interventions Study Group. Interventions to address deaths from childhood pneumonia and diarrhoea equitably: what works and at what cost? Lancet. 2013 Apr 20;381(9875):1417-1429. doi: 10.1016/S0140-6736(13)60648-0. Epub 2013 Apr 12.
PubMed 23582723Matai S, Peel D, Wandi F, Jonathan M, Subhi R, Duke T. Implementing an oxygen programme in hospitals in Papua New Guinea. Ann Trop Paediatr. 2008 Mar;28(1):71-8. doi: 10.1179/146532808X270716.
PubMed 18318953Soofi S, Ahmed S, Fox MP, MacLeod WB, Thea DM, Qazi SA, Bhutta ZA. Effectiveness of community case management of severe pneumonia with oral amoxicillin in children aged 2-59 months in Matiari district, rural Pakistan: a cluster-randomised controlled trial. Lancet. 2012 Feb 25;379(9817):729-37. doi: 10.1016/S0140-6736(11)61714-5. Epub 2012 Jan 27.
PubMed 22285055Yeboah-Antwi K, Pilingana P, Macleod WB, Semrau K, Siazeele K, Kalesha P, Hamainza B, Seidenberg P, Mazimba A, Sabin L, Kamholz K, Thea DM, Hamer DH. Community case management of fever due to malaria and pneumonia in children under five in Zambia: a cluster randomized controlled trial. PLoS Med. 2010 Sep 21;7(9):e1000340. doi: 10.1371/journal.pmed.1000340.
PubMed 20877714Faulkner L. Beyond the five-user assumption: benefits of increased sample sizes in usability testing. Behav Res Methods Instrum Comput. 2003 Aug;35(3):379-83. doi: 10.3758/bf03195514.
PubMed 14587545King C, Boyd N, Walker I, Zadutsa B, Baqui AH, Ahmed S, Islam M, Kainja E, Nambiar B, Wilson I, McCollum ED. Opportunities and barriers in paediatric pulse oximetry for pneumonia in low-resource clinical settings: a qualitative evaluation from Malawi and Bangladesh. BMJ Open. 2018 Jan 30;8(1):e019177. doi: 10.1136/bmjopen-2017-019177.
PubMed 29382679
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Robust and Reliable Pulse Oximeter for Use by Frontline Healthcare Providers Caring for Children With Pneumonia in Low-income Countries
- ClinicalTrials.gov ID
- NCT02941237
- Acronym / sponsor ID
- OPP1133291
- Keywords
- Pulse oximetry, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- The Lifebox FoundationUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University College, London, PACHI Malawi - Parent and Child Health Initiative Trust, Bill and Melinda Gates Foundation
- Study start
- 2 May 2017 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 21 Oct 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.
This study is to test the usability of a new pulse oximeter probe designed for children 0-5 years.
Detailed description
Pneumonia is the leading infectious cause of death in children under five. World Health Organization guidelines recommend measurement of peripheral oxygen saturation (SpO2) in children with pneumonia to guide treatment. This project focuses on the design of a new 'Lifebox' pulse oximeter probe for use in children 0-5 years of age.
A new oximeter probe compatible with the Lifebox oximeter has been designed to be used for children 0-5 years in all settings.
The aims of the study are to:
- to evaluate the usability of the redesigned Lifebox oximeter probe by an expert user
- to evaluate the usability of the redesigned oximeter probe by trained healthcare workers, against defined product specifications.
- to compare the usability of the redesigned oximeter probe to a market leading probe
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare worker measurement of SpO2 | Other | Device: Pulse oximeterMeasurement of SpO2 using the Lifebox pulse oximeter probe in children of different ages, stratified by age: 0-1 months, 2-11 months, 12-23 months and 24-59 months |
| Expert measurement of SpO2 | Other | Device: Pulse oximeterMeasurement of SpO2 using the Lifebox pulse oximeter probe and Masimo oximeter probe in children of different ages, stratified by age: 0-1 months, 2-11 months, 12-23 months and 24-59 months |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Inpatients (or child awaiting surgery on pre-operative ward) in Great Ormond Street Hospital, or government facilities in Malawi and Bangladesh
- Aged 0 - 59 months
- Clinically stable (as judged by the ward sister and medical team)
- Parent (or adult with parental responsibility) present
- Informed consent from the parent (or adult with parental responsibility)
Key exclusion criteria (8 listed)
- Unstable or critically unwell patients (as judged by their medical team)
- Parents (or adult with parental responsibility) who are not able or willing to give informed consent
- Parents (or adult with parental responsibility) unable to speak English well enough to understand study methods or consent form (UK only)
- For part of the study assessing usability of the probe by healthcare workers, patients with oxygen saturation 95% or below will be excluded
- Healthcare providers who are not trained to use a pulse oximeter
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 |
|---|---|---|
| Pulse oximeterTime taken to measure oxygen saturation. Completion of usability questionnaire | Device | Expert measurement of SpO2, Healthcare worker measurement of SpO2 |
Primary outcome
Time to obtain SpO2 reading
Time frame: Through completion of study, average one hour
The time to obtain a stable reading will be declared by the healthcare worker or expert and noted by the independent observer, to give a proportion fulfilling the Target Product Profile (TPP).
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 9 Mar 2023.
- Background: PubMed 25552770Burn SL, Chilton PJ, Gawande AA, Lilford RJ. Peri-operative pulse oximetry in low-income countries: a cost-effectiveness analysis. Bull World Health Organ. 2014 Dec 1;92(12):858-67. doi: 10.2471/BLT.14.137315. Epub 2014 Sep 24.
- Background: PubMed 24738801Finch LC, Kim RY, Ttendo S, Kiwanuka JK, Walker IA, Wilson IH, Weiser TG, Berry WR, Gawande AA. Evaluation of a large-scale donation of Lifebox pulse oximeters to non-physician anaesthetists in Uganda. Anaesthesia. 2014 May;69(5):445-51. doi: 10.1111/anae.12632.
- Background: PubMed 25280870Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.
- Background: PubMed 18708248Duke T, Wandi F, Jonathan M, Matai S, Kaupa M, Saavu M, Subhi R, Peel D. Improved oxygen systems for childhood pneumonia: a multihospital effectiveness study in Papua New Guinea. Lancet. 2008 Oct 11;372(9646):1328-33. doi: 10.1016/S0140-6736(08)61164-2. Epub 2008 Aug 15.
- Background: PubMed 23582723Bhutta ZA, Das JK, Walker N, Rizvi A, Campbell H, Rudan I, Black RE; Lancet Diarrhoea and Pneumonia Interventions Study Group. Interventions to address deaths from childhood pneumonia and diarrhoea equitably: what works and at what cost? Lancet. 2013 Apr 20;381(9875):1417-1429. doi: 10.1016/S0140-6736(13)60648-0. Epub 2013 Apr 12.
- Background: PubMed 18318953Matai S, Peel D, Wandi F, Jonathan M, Subhi R, Duke T. Implementing an oxygen programme in hospitals in Papua New Guinea. Ann Trop Paediatr. 2008 Mar;28(1):71-8. doi: 10.1179/146532808X270716.
- Background: PubMed 22285055Soofi S, Ahmed S, Fox MP, MacLeod WB, Thea DM, Qazi SA, Bhutta ZA. Effectiveness of community case management of severe pneumonia with oral amoxicillin in children aged 2-59 months in Matiari district, rural Pakistan: a cluster-randomised controlled trial. Lancet. 2012 Feb 25;379(9817):729-37. doi: 10.1016/S0140-6736(11)61714-5. Epub 2012 Jan 27.
- Background: PubMed 20877714Yeboah-Antwi K, Pilingana P, Macleod WB, Semrau K, Siazeele K, Kalesha P, Hamainza B, Seidenberg P, Mazimba A, Sabin L, Kamholz K, Thea DM, Hamer DH. Community case management of fever due to malaria and pneumonia in children under five in Zambia: a cluster randomized controlled trial. PLoS Med. 2010 Sep 21;7(9):e1000340. doi: 10.1371/journal.pmed.1000340.
- Background: PubMed 14587545Faulkner L. Beyond the five-user assumption: benefits of increased sample sizes in usability testing. Behav Res Methods Instrum Comput. 2003 Aug;35(3):379-83. doi: 10.3758/bf03195514.
- Derived from this study: PubMed 29382679King C, Boyd N, Walker I, Zadutsa B, Baqui AH, Ahmed S, Islam M, Kainja E, Nambiar B, Wilson I, McCollum ED. Opportunities and barriers in paediatric pulse oximetry for pneumonia in low-resource clinical settings: a qualitative evaluation from Malawi and Bangladesh. BMJ Open. 2018 Jan 30;8(1):e019177. doi: 10.1136/bmjopen-2017-019177.
- Description of usability testing from the British Standards InstituteLink provided by the sponsor.
- Guidance from British Standards Institute on best practices in usability testingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Isabeau A Walker, FRCA principal investigator
Great Ormond Street Hospital NHS Foundation Trust
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse oximeter in people with Pneumonia in Children and Measurement of Peripheral Oxygen Saturation, run by The Lifebox Foundation at 3 sites in 3 countries.
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 9 inclusion and 8 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bangladesh, Malawi, 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?
Time to obtain SpO2 reading (time frame: Through completion of study, average one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02941237, which also lists 10 linked publications.
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 9 Mar 2023.