CClinicalTrials.gg
Sign In
CompletedNCT02941237Updated Mar 9, 2023

Development of a Robust and Reliable Pulse Oximeter for Children With Pneumonia in Low-income Countries

An interventional study of Pulse oximeter in Pneumonia in Children and Measurement of Peripheral Oxygen Saturation, sponsored by The Lifebox Foundation. Completed at 3 sites in 3 countries. Open to participants aged Up to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-09.

Sponsored by The Lifebox Foundation · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
572
Allocation
Non-randomized
Ages
Up to 5 Years
Sex
All
01

Study summary

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:

  1. to evaluate the usability of the redesigned Lifebox oximeter probe by an expert user
  2. to evaluate the usability of the redesigned oximeter probe by trained healthcare workers, against defined product specifications.
  3. to compare the usability of the redesigned oximeter probe to a market leading probe
02

Conditions studied

  • Pneumonia in Children
  • Measurement of Peripheral Oxygen Saturation

Browse trials for

Keywords

  • Pulse oximetry
  • Children
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 572 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

The Lifebox Foundation is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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)

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

Exclusion criteria

Exclusion Criteria:

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
572 participants (actual)

Study arms

  • Other
    Healthcare worker measurement of SpO2

    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

    Device: Pulse oximeter

  • Other
    Expert measurement of SpO2

    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

    Device: Pulse oximeter

Interventions

  • DevicePulse oximeter

    Time taken to measure oxygen saturation. Completion of usability questionnaire

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Through completion of study, average one hour

Other outcomes

  1. Usability questionnaire

    Healthcare workers and the expert user will complete a usability questionnaire after completion of readings in children of different ages

    Time frame: Through study completion, average one hour

07

Study locations

3 sites
  • Sylhet hospital
    Sylhet, Bangladesh
  • District and referral hospitals
    Lilongwe, Malawi
  • Great Ormond Street Hospital NHS Foundation Trust
    London, WC1N 3JH, United Kingdom
08

References and documents

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 25552770 ↗
  • Finch 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 24738801 ↗
  • Liu 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. Erratum In: Lancet. 2015 Jan 31;385(9966):420. Lancet. 2016 Jun 18;387(10037):2506. doi: 10.1016/S0140-6736(16)30805-4. PubMed 25280870 ↗
  • Duke 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 18708248 ↗
  • Bhutta 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 23582723 ↗
  • Matai 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 18318953 ↗
  • Soofi 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 22285055 ↗
  • Yeboah-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 20877714 ↗
  • Faulkner 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 14587545 ↗
  • King 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 documents

  • Protocol and statistical analysis plan · Jan 26, 2017
  • Informed consent form · Oct 24, 2016
  • Informed consent form · Oct 24, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02941237
Lead sponsor
The Lifebox Foundation
Collaborators
Johns Hopkins University, University College, London, PACHI Malawi - Parent and Child Health Initiative Trust, Bill and Melinda Gates Foundation
Responsible party
Isabeau Walker (Consultant Paediatric Anaesthetist, Honorary Senior Lecturer Great Ormond Street Hospital NHS Foundation Trust, The Lifebox Foundation) — Principal investigator
First posted
Oct 21, 2016
Start date
May 2, 2017
Primary completion
Jun 2, 2017
Completion
Jun 1, 2018
Last update
Mar 9, 2023

Study contacts

Isabeau A Walker, FRCA
principal investigator · Great Ormond Street Hospital NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pneumonia→

Other studies from this sponsor

The Lifebox Foundation

Start the discussion