Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001071819
Ethics application status
Approved
Date submitted
28/07/2021
Date registered
13/08/2021
Date last updated
13/08/2021
Date data sharing statement initially provided
13/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pulse Oximetry and Oxygen Services for the Care of Acutely Unwell Children with Pneumonia or COVID-19 Attending Frontline Health Facilities in Lagos, Nigeria (INSPIRING-Lagos)
Scientific title
Pulse Oximetry and Oxygen Services for the Care of Acutely Unwell Children with Pneumonia or COVID-19 Attending Frontline Health Facilities in Lagos, Nigeria (INSPIRING-Lagos)
Secondary ID [1] 304861 0
None
Universal Trial Number (UTN)
Trial acronym
INSPIRING-Lagos (Integrated Sustainable Childhood Pneumonia and Infectious disease Reduction in Nigeria - Lagos)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pneumonia 322962 0
COVID-19 323144 0
hypoxaemia 323145 0
Condition category
Condition code
Respiratory 320539 320539 0 0
Other respiratory disorders / diseases
Infection 320718 320718 0 0
Other infectious diseases
Public Health 320719 320719 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project will establish “stabilisation rooms” within the outpatient areas of participating primary facilities, designed to allow for short-term oxygen delivery for children with hypoxaemia prior to transfer to hospital (or admission to the ward). These stabilisation rooms are intended to support both short-term COVID-19 and longer-term paediatric pneumonia care needs, and will consist of the following intervention components:
1. Pulse oximeters, equipped with both paediatric and adult re-usable probes;
2. Medical oxygen supply delivered through newly installed oxygen concentrators powered from mains supply, generators and/or solar power;
3. Clinical guidelines and job aids (alongside clinical training, described below).
Secondary health facilities that admit children will also be supported with pulse oximeters and oxygen concentrators for use on the wards to support safe care of patients referred for inpatient care.
Precise use of the stabilisation room will vary between facilities, but in general: all acutely unwell children will be screened for hypoxaemia; all children with severe hypoxaemia (SpO<90%) will be commenced on oxygen therapy; all hypoxaemia children will be admitted for a period of observation/treatment either at the same facility or via referral to a larger facility.
Selection of devices was based on national and international technical guidance and experience with similar devices in Nigeria and elsewhere. To facilitate a sub-study comparing the usability and acceptability of two oximeters, facilities will be randomly allocated to receive either Lifebox (Acare Technology, New Taipei City, Taiwan) or Masimo RadG (Masimo, Irvine CA, USA) oximeters.
We anticipate a 1-6 month delay in receiving both oxygen and oximetry equipment, given the global supply chain challenges during the COVID-19 pandemic; therefore, the evaluation design will need to be adaptive and flexible. The intervention will be delivered by Save the Children Nigeria, with technical support provided by private non-profit Oxygen for Life Initiative (OLI), working closely with local government.

The stabilisation rooms will be implemented alongside broader capacity-building activities targeting primary care HCW practices (preventive and curative). This will include training on WHO’s IMCI guidelines, pulse oximetry and oxygen therapy, immunization, and nutrition.
- Integrated Management of Childhood Illness (IMCI) In primary facilities, 6 days. For Community Health Extension Worker, Community Health Officers, nurses,
- Pulse oximetry and Oxygen therapy In primary and secondary care facilities, 3 days. Community Health Extension Worker, Community Health Officers, nurses, midwives, doctors, +/- technicians
- Immunization “Reaching Every District” In primary care facilities, 2-3 days. Vaccinators, immunisation focal persons, facility officer in charge
- Nutrition – Infant and Young Child Feeding (IYCF), Community Management of Acute Malnutrition (CMAM) In training centre and primary care facilities, 3 days.
Repeated after 1 year for new staff. Community Health Extension Worker, Community Health Officers, nurses, nutrition focal person

All training activities will be coordinated by Save the Children Nigeria using the ADDIE model (A = Analysis, D = Design, D = Develop Training Materials, I = Implement/Delivery, and E = Evaluation). Save the Children Nigeria will conduct a Training Needs Assessments using their “Task Analysis” tools, assessing a health care worker’s actual skills and knowledge compared to the skills and knowledge they are meant to have based on their job descriptions. The training will be adapted from existing standard training packages to the local context with the assistance of local facilitators selected from the State Ministry of Health (SMOH) and partners (e.g. WHO, UNICEF, OLI). Training is based on existing modules (e.g. IMCI) where available and will involve a mix of didactic, observational, and participatory teaching strategies.
Local facilitators who lead the training will also act as coaches, mentors and supervisors after the training has been completed and the participants have been deployed. They will visit each facility every 4-6 weeks and maintain interim contact using mobile phone-based group messaging. The Ikorodu LGA health team will also contribute to supervision through existing immunization supportive supervision arrangements.
External evaluation team members will attend some training activities as observers and review administrative records to evaluate intervention fidelity. Clinical data collection will include items to measure adherence to guidelines.
The program will be delivered and evaluated over 2 years (12 month intervention period), and may continue indefinitely following satisfactory program evaluation.
Intervention code [1] 321247 0
Treatment: Devices
Comparator / control treatment
This is an non-randomised before-after study.
The control period –before the interventions are delivered in study facilities– will consist of routine clinic operation with existing material resources. Baseline duration is 12 months.
Control group
Historical

Outcomes
Primary outcome [1] 328358 0
The primary outcome is the correct management of hypoxaemic pneumonia amongst children aged 0-59 months who present to a participating health facility. ‘Correct management’ is defined as the child receiving oxygen treatment and being referred to and subsequently attending hospital (all three criteria need to be met). Clinical pneumonia is defined according to the 2014 IMCI guidelines. Oxygen treatment and referral decision will be recorded at recruitment, and hospital attendance, treatment and deaths will be confirmed by telephone interview at a 2-weeks and via medical records where available.
Timepoint [1] 328358 0
On day 1 of presentation, with follow up after 14 days.
Oxygen treatment and referral decision will be recorded at recruitment, and hospital attendance, treatment and deaths will be confirmed by telephone interview at a 2-weeks and via medical records where available.
Secondary outcome [1] 398705 0
Mortality at 14 days for children aged 0-59 months who present to a participating health facility with WHO IMCI pneumonia.
Timepoint [1] 398705 0
14-days after initial presentation to participating facility
Secondary outcome [2] 398706 0
Number of participants presenting, and being admitted, for care following initial visit, based on facility clinical records and caregiver report at 14-day follow up.
Timepoint [2] 398706 0
14-days after initial presentation to participating facility
Secondary outcome [3] 399359 0
Quality of care provided to participants compared to guidelines using systematic record of clinical: assessment; diagnosis, treatment, monitoring.
Timepoint [3] 399359 0
During presentation/admission and on 14 day follow up
Secondary outcome [4] 399360 0
Participant adherence to care instructions based on facility records and participant report at 14-day follow up
Timepoint [4] 399360 0
14-day follow up
Secondary outcome [5] 399556 0
Cost of care to participants based on report at 14-day follow up.
Timepoint [5] 399556 0
14-day follow up
Secondary outcome [6] 399557 0
Fidelity of intervention to planned based on administrative records supplemented by direct observation by study staff
Timepoint [6] 399557 0
Quarterly throughout the intervention period
Secondary outcome [7] 399558 0
Intervention reach will be assessed by tracking the coverage of trained staff and functional equipment throughout the duration of the project.
Timepoint [7] 399558 0
Quarterly throughout the intervention period
Secondary outcome [8] 399560 0
Mechanisms of impact: We will conduct focus group discussions (FGDs) and in-depth interviews (IDIs) with HCWs to understand their perceptions about pulse oximetry and oxygen therapy and understand changes over time.
Timepoint [8] 399560 0
Towards the end of intervention period.
Secondary outcome [9] 399561 0
Community perceptions: We will conduct interviews and FGDs with caregivers, to understand perceptions about oxygen and behavioural responses to the intervention. We will triangulate this qualitative data with quantitative data collected in the follow-up surveys to understand changes in care-seeking behaviours following the intervention.
Timepoint [9] 399561 0
Towards the end of the intervention period.

Eligibility
Key inclusion criteria
The intervention and impact evaluation will focus on children aged 0-59 months attending the outpatient areas of participating facilities for an acute illness and who are diagnosed with clinical pneumonia defined according to the 2014 WHO IMCI guidelines.
Minimum age
0 Months
Maximum age
59 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No additional exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a before-after study with intervention applied at the health facility level. Individual participants will receive either "usual care" or "usual care plus stabilisation room care" depending on the timing of program implementation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

The primary analysis will be a time-series analysis, using a change point model. In this analysis an intervention time point is not pre-specified, therefore, given the challenges we will face in defining clean “pre” and “post” intervention periods, this method allows more flexibility and fewer assumptions than interrupted time-series analysis. We will be able to assess whether: 1) changes in incidence have occurred; 2) identifies the most likely time for the change point, which we can link to the intervention and other key events.
Sensitivity analyses will include: stratification by age-group and sex of the child; stratification by clinic type; and stratification by pneumonia severity classification. We will account for clustering of outcomes at clinic-level in analyses and explore the role of intervention dose-effects.
Secondary analyses will include: assessing impact on 14-day mortality; describing the epidemiology of hypoxaemia amongst children; predictive modelling of pneumonia mortality and hypoxaemia; analysis of changes in clinical attendance rates, referral decision making, and referral attendance over time; description of suspected COVID19 epidemiology.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/08/2020
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
1800
Accrual to date
840
Final
Recruitment outside Australia
Country [1] 24002 0
Nigeria
State/province [1] 24002 0
Lagos, Ikorodu LGA

Funding & Sponsors
Funding source category [1] 309234 0
Charities/Societies/Foundations
Name [1] 309234 0
Save the Children UK
Country [1] 309234 0
United Kingdom
Funding source category [2] 309236 0
Commercial sector/Industry
Name [2] 309236 0
GlaxoSmithKline (GSK)
Country [2] 309236 0
United Kingdom
Primary sponsor type
University
Name
University College London
Address
Gower St, London WC1E 6BT, UK
Country
United Kingdom
Secondary sponsor category [1] 310202 0
None
Name [1] 310202 0
Address [1] 310202 0
Country [1] 310202 0
Other collaborator category [1] 281921 0
University
Name [1] 281921 0
University of Ibadan | University College Hospital
Address [1] 281921 0
Queen Elizabeth II Road, Agodi, Ibadan
Country [1] 281921 0
Nigeria
Other collaborator category [2] 281922 0
University
Name [2] 281922 0
Johns Hopkins University
Address [2] 281922 0
Wolfe St, Baltimore, MD 21218
Country [2] 281922 0
United States of America
Other collaborator category [3] 281923 0
University
Name [3] 281923 0
Karolinska Institutet
Address [3] 281923 0
Solnavägen 1, 171 77 Solna
Country [3] 281923 0
Sweden
Other collaborator category [4] 281926 0
Charities/Societies/Foundations
Name [4] 281926 0
Murdoch Children's Research Institute (MCRI)
Address [4] 281926 0
Royal Children's Hospital, 50 Flemington Rd, Parkville VIC 3052
Country [4] 281926 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309081 0
University College Hospital / University of Ibadan Research Ethics Committee
Ethics committee address [1] 309081 0
Ethics committee country [1] 309081 0
Nigeria
Date submitted for ethics approval [1] 309081 0
12/11/2019
Approval date [1] 309081 0
10/01/2020
Ethics approval number [1] 309081 0
REF UI/EC/19/0551
Ethics committee name [2] 309083 0
Lagos State Government Human Research Ethics Committee
Ethics committee address [2] 309083 0
Ethics committee country [2] 309083 0
Nigeria
Date submitted for ethics approval [2] 309083 0
01/12/2019
Approval date [2] 309083 0
27/01/2020
Ethics approval number [2] 309083 0
REF LS/PHCB/MS/1128/VOL.V1/005
Ethics committee name [3] 309084 0
University College London (UCL) Research Ethics Committee
Ethics committee address [3] 309084 0
Ethics committee country [3] 309084 0
United Kingdom
Date submitted for ethics approval [3] 309084 0
01/08/2019
Approval date [3] 309084 0
27/09/2019
Ethics approval number [3] 309084 0
REF 3433/005

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112910 0
A/Prof Tim Colbourn
Address 112910 0
University College Hospital (UCL)
Gower St, London WC1E 6BT
Country 112910 0
United Kingdom
Phone 112910 0
+447807988639
Fax 112910 0
Email 112910 0
[email protected]
Contact person for public queries
Name 112911 0
Tim Colbourn
Address 112911 0
University College Hospital (UCL)
Gower St, London WC1E 6BT
Country 112911 0
United Kingdom
Phone 112911 0
+447807988639
Fax 112911 0
Email 112911 0
[email protected]
Contact person for scientific queries
Name 112912 0
Tim Colbourn
Address 112912 0
University College Hospital (UCL)
Gower St, London WC1E 6BT
Country 112912 0
United Kingdom
Phone 112912 0
+447807988639
Fax 112912 0
Email 112912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Fully anonymised versions of the data will be archived at the close of the project, for sharing with other researchers. A copy of the clean, anonymised data will be stored by UCL, University College Hospital Ibadan and Save the Children.
When will data be available (start and end dates)?
Data will be made available after completing primary analysis in December 2022, and will be available for minimum 10 years after study completion.
Available to whom?
Other researchers on request. Some data may be made available in an online data repository.
Available for what types of analyses?
Not defined.
How or where can data be obtained?
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePulse oximetry and oxygen services for the care of children with pneumonia attending frontline health facilities in Lagos, Nigeria (INSPIRING-Lagos): Study protocol for a mixed-methods evaluation.2022https://dx.doi.org/10.1136/bmjopen-2021-058901
EmbaseCare seeking for under-five children and vaccine perceptions during the first two waves of the COVID-19 pandemic in Lagos State, Nigeria: a qualitative exploratory study.2023https://dx.doi.org/10.1136/bmjopen-2022-069294
N.B. These documents automatically identified may not have been verified by the study sponsor.