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Trial registered on ANZCTR


Registration number
ACTRN12621000241831
Ethics application status
Approved
Date submitted
24/11/2020
Date registered
8/03/2021
Date last updated
21/02/2022
Date data sharing statement initially provided
8/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the impact of FREO2 technology on access to oxygen therapy for children in Uganda.
Scientific title
Impact of the FREO2 oxygen system on access to oxygen therapy for hypoxaemic paediatric admissions in health centres and hospitals in western Uganda.
Secondary ID [1] 302857 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxaemia 319846 0
Condition category
Condition code
Respiratory 317784 317784 0 0
Other respiratory disorders / diseases
Public Health 318139 318139 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Hypoxaemia due to respiratory and non-respiratory conditions is a major killer of children in low resource settings. Oxygen is scarce and expensive. The FREO2 foundation has developed a set of technological solutions to this problem. The FREO2 oxygen system consists of a reliable concentrator (manufactured by Krober), a device to store oxygen for use during power outages (low pressure oxygen storage device), a back-up oxygen cylinder, and a mechanism to switch between oxygen sources automatically. This technology, along with pulse oximetry will be introduced to 20 facilities in western Uganda, in a step-wise, non-randomised fashion. The system will therefore be the primary source of oxygen for paediatric and neonatal admissions across these facilities. All children admitted in the post-implementation period will receive oxygen via the FREO2 system.
Clinical outcomes (eg. proportion of hypoxaemic children who receive oxygen), economic outcomes (eg. total cost of oxygen, cost per child treated) and technical outcomes (eg. equipment durability) will be measured, and compared pre and post implementation.
The total study period is 2 years, with timing of facility rolled being sequential over that time period. Each facility will receive training and pulse oximeters, and 2-3 months later, installation of the FREO2 Oxygen System.
Hypoxaemia will be defined as SpO2<90% using pulse oximetry. Oxygen is provided by trained nurses and hospital medical officers to neonatal and paediatric patients using nasal prongs, with flow rates consistent with WHO recommendations (0.5-1 l/m for neonates, and 1-2 l/m for infants and children). Oxygen is continued until a patient can consistently maintain SpO2>90% on room air, and there is evidence of improvement in other clinical features of underlying condition.
Medical records will be reviewed weekly by research personnel to review SpO2 on admission, clinical signs of hypoxaemia, details of oxygen therapy including flow rates and duration of therapy.
Intervention code [1] 319405 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325803 0
Proportion of children with hypoxaemia who receive oxygen pre and post intervention. Medical records are reviewed weekly by study personnel to record number of hypoxaemia admissions (children with SpO2<90% on admission), and whether they received oxygen. These data will be entered on RedCAP forms.
Timepoint [1] 325803 0
Pre-post intervention comparison. 3 months pre-intervention period, and 3 months post-intervention.
Secondary outcome [1] 389193 0
Cost per additional child with hypoxaemia receiving oxygen.
Intervention costs will be recorded prospectively for each facility - cost of equipment, implementation, training etc.
Health facility pre-intervention expenditure on oxygen is obtained from health facility financial records.
Timepoint [1] 389193 0
Pre-post intervention comparison. Pre-intervention and 3-6 months post-intervention.
Secondary outcome [2] 390187 0
Total cost of oxygen, using hospital records and private oxygen supplier costings.
Timepoint [2] 390187 0
Baseline (pre-intervention) and 3-6 months post intervention.
Secondary outcome [3] 390188 0
Equipment durability, using oxygen concentrator logs and maintenance / repair logs.
Timepoint [3] 390188 0
3-6 months post-implementation.
Secondary outcome [4] 392309 0
Length of stay, using admission and discharge records to calculate length of stay in days.
Timepoint [4] 392309 0
Baseline (3 months pre-intervention) and 3-6 months post intervention.
Secondary outcome [5] 392310 0
Mortality, using admission and outcomes records to calculate the number of neonatal and paediatric deaths following admission.
Timepoint [5] 392310 0
Baseline (3 months pre-intervention) and 3-6 months post-intervention
Secondary outcome [6] 392313 0
Duration of oxygen therapy (hours or days), using medical records to record time of oxygen commencement and cessation.
Timepoint [6] 392313 0
Baseline (3 months pre-intervention) and 3-6 months post intervention
Secondary outcome [7] 392314 0
Oxygen flow rates in post-intervention period. Using medical records to assess median flow rates in l/m of oxygen.
Timepoint [7] 392314 0
3-6 months post intervention

Eligibility
Key inclusion criteria
All neonatal and paediatric admission to included facilities.
Minimum age
0 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
The primary outcome – the proportion of hypoxaemic children receiving oxygen – will be compared pre and post intervention using a mixed effects logistic regression to account for clustering (by facility) and time.
The cost to avert one hypoxaemic child not receiving oxygen because of unavailability will be calculated by dividing the total cost of the system by the additional number of hypoxaemic children accessing oxygen.
For other economic and technical outcomes, such as costs, equipment functioning, secondary clinical outcomes, pooled data from all facilities will be summarised pre and post intervention and compared across both periods using standard tests of significance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/01/2021
Date of last participant enrolment
Anticipated
12/08/2022
Actual
Date of last data collection
Anticipated
14/10/2022
Actual
Sample size
Target
6000
Accrual to date
6400
Final
Recruitment outside Australia
Country [1] 23117 0
Uganda
State/province [1] 23117 0
Western Uganda

Funding & Sponsors
Funding source category [1] 307276 0
Government body
Name [1] 307276 0
Grand Challenges Canada
Country [1] 307276 0
Canada
Primary sponsor type
Charities/Societies/Foundations
Name
FREO2 Foundation
Address
FREO2 foundation
School of Physics (David Caro Building) – Building 192
Gate 1, corner Tin Alley and Swanston Street
The University of Melbourne
VIC 3010 Australia
Country
Australia
Secondary sponsor category [1] 307909 0
None
Name [1] 307909 0
None
Address [1] 307909 0
none
Country [1] 307909 0
Other collaborator category [1] 281548 0
Charities/Societies/Foundations
Name [1] 281548 0
Brick by Brick Foundation
Address [1] 281548 0
Lastonet Business Center, Adjacent to Bank of Africa and Coaster Taxi Park, Kampala Rd, Masaka, Uganda
Country [1] 281548 0
Uganda

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307372 0
Mbarrara University of Science and Technology
Ethics committee address [1] 307372 0
Ethics committee country [1] 307372 0
Uganda
Date submitted for ethics approval [1] 307372 0
06/11/2020
Approval date [1] 307372 0
16/12/2020
Ethics approval number [1] 307372 0
MUREC 1/7
Ethics committee name [2] 307373 0
Human Ethics Advisory Group (HEAG), Department of Paediatrics
Ethics committee address [2] 307373 0
Ethics committee country [2] 307373 0
Australia
Date submitted for ethics approval [2] 307373 0
16/12/2020
Approval date [2] 307373 0
14/01/2021
Ethics approval number [2] 307373 0
2021-14489-13654-2

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

Contacts
Principal investigator
Name 107002 0
Dr Daniel Murokora
Address 107002 0
Brick by Brick Uganda
Masaka-Kyotera Road, Bulinda Village Kalisizo Town, Kyotera
District P.O Box 972
Country 107002 0
Uganda
Phone 107002 0
+256 200 902 073
Fax 107002 0
Email 107002 0
murokora@gmail.com
Contact person for public queries
Name 107003 0
Bryn Sobott
Address 107003 0
School of Physics (David Caro Building) – Building 192
Gate 1, corner Tin Alley and Swanston Street
The University of Melbourne
VIC 3010 Australia
Country 107003 0
Australia
Phone 107003 0
+613 9035 5511
Fax 107003 0
Email 107003 0
bryn@freo2.org
Contact person for scientific queries
Name 107004 0
Rami Subhi
Address 107004 0
Department of Paediatrics,
Royal Children's Hospital
50 Flemington Rd
Parkville, VIC 3052
Country 107004 0
Australia
Phone 107004 0
+613 9035 5511
Fax 107004 0
Email 107004 0
rami.subhi@rch.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbaseTechnology to improve reliable access to oxygen in Western Uganda: Study protocol for a phased implementation trial in neonatal and paediatric wards.2022https://dx.doi.org/10.1136/bmjopen-2021-054642
N.B. These documents automatically identified may not have been verified by the study sponsor.