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Investigating the impact of FREO2 technology on access to oxygen therapy for children in Uganda.

Impact of the FREO2 oxygen system on access to oxygen therapy for hypoxaemic paediatric admissions in health centres and hospitals in western Uganda.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000241831
Enrollment
6400
Registered
2021-03-08
Start date
2021-01-18
Completion date
2022-08-12
Last updated
2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Oxygen is a scarce resource where it is most needed. Supplies are expensive and unreliable. Low blood oxygen levels (hypoxaemia) is a common complication of illness at all ages, and increases risk of death and morbidity. Oxygen treatment saves lives and is essential for good quality of care. The FREO2 Foundation aims to find technological solutions to improve oxygen access in low resource settings. A combination of different technologies have been integrated into the one system (FREO2 Oxygen System). This includes a robust oxygen concentrator, capacity to store oxygen at low pressure for use when power is off or unstable, a back-up oxygen cylinder, and an automatic switch between those oxygen sources to ensure constant oxygen supply to children. The system was implemented in Mbarara Regional Referral Hospital in Western Uganda and continues to reliably supply oxygen to 4 paediatric beds. The aim of this project is to expand the system to 20 hospitals and clinics to learn how to implement this innovation at scale.

Interventions

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 automatic

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.

Sponsors

FREO2 Foundation
Lead SponsorCharities/Societies/Foundations

Eligibility

Sex/Gender
All
Age
0 to 12 Years
Healthy volunteers
No

Inclusion criteria

All neonatal and paediatric admission to included facilities.

Exclusion criteria

No exclusion criteria.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026