Evaluation of a Multi-country Medical Oxygen Program

NCT06087315 | Recruiting

• 1 other identifier: HREC97817
• Study Type: observational
• Target: 1,200
• Locations: 3 countries
• Sites: 3

Brief Summary

REAL-MOXY is a set of 5 mixed methods studies designed to understand how oxygen and pulse oximetry are used (or not used) at a facility level, to identify opportunities and barriers for strengthening oxygen systems for beneficiaries, users and managers.

Conditions

Hypoxemia; Neonatal Disease; Pneumonia; Sepsis; Morality

Keywords

Oxygen systems; Pulse oximetry; Low middle income countries; Global health; Mixed-methods evaluation; Realist evaluation

Outcome Measures

Primary Outcomes (1)

• Mixed methods

  Mixed methods

  5 years

Interventions

Multi-faceted oxygen systems strengthening interventions (different for each country) OTHER

The specific approaches are different in each country but broadly include efforts to: (1) strengthening policies, strategies, and governance of medical oxygen production, distribution, maintenance, and use; (2) building capacity of healthcare workers and technicians to use and maintain oxygen well, and (3) strengthening oxygen-related data acquisition and use for forecasting, budgeting, and monitoring.

Eligibility Criteria

• Age: 0 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

As above

Sub-study 1: Research Question: What are the baseline pulse oximetry and oxygen practices for children admitted to participating health facilities, and what is the level of institutional readiness for oxygen service delivery? Which facilities, representative of high- and low-performing facilities and different levels of care and facility types, can be selected for additional investigation to understand current functioning of oxygen systems? Setting and Population: The broader MOXY program baseline cross-sectional assessments involve 9 countries. We have selected 6 MOXY countries for the mixed methods studies outlined in this protocol - Nigeria, Uganda, Liberia, Rwanda, Cambodia and Lao PDR - based on pre-existing research collaborations, and with the aim of representing broadly different geographical contexts. Baseline assessments are being conducted in all facilities participating in the MOXY program in each of the 6 study countries. From this data set, we will analyse primary and secondary outcomes for wards caring for children \<15 years (including neonatal wards where relevant). Analysis/outcomes: Primary - proportion of admitted children (\<15 years, including neonates) screened with pulse oximetry. Secondary - proportion of admitted children with hypoxaemia (\<15 years, including neonates) treated with oxygen. For Real-Moxy the secondary outcome will inform identification of facilities for inclusion. Sub-study 2: Research question: Where and how are patients managed from arrival to admission and discharge (or transfer), and how does oxygen equipment move within and between clinical areas? How do process maps vary for different clinical scenarios representing different patient groups: i) pneumonia with and without hypoxaemia; ii) severe, acute illness syndrome with WHO emergency signs (e.g., shock, multi-trauma, seizures); iii) surgical condition and iv) neonatal illness (inborn and outborn)? Setting and Population: This will be conducted in 10 health facilities in each of the 6 countries (Nigeria, Uganda, Liberia, Rwanda, Lao PDR, Cambodia), selected to represent high and low functioning facility oxygen systems and include secondary and tertiary health facilities from government and non-governmental sectors (identified in sub-study 1). We will focus on admitted children (\<15 years, including neonates) with (i) pneumonia, (ii) other acute illness with WHO emergency signs, (iii) surgical conditions, and (iv) neonatal illness. We have chosen these conditions to represent diagnoses with a high prevalence of hypoxaemia, and to capture the nuances of how pulse oximetry and oxygen practices are adapted (or not adapted) to clinical scenarios (e.g., having a lower threshold to provide oxygen to a patient in shock; or targeting safe oxygen saturations in neonates). Analysis/outcomes: Facility maps of patient and equipment flow. Sub-study 3: Research question: What is the sequence of emergency care for an unwell child in the first 4 hours, and how are decisions made - particularly relating to oxygen (when to start, stop, how much, what delivery modality, etc.)? What are the points of delays to appropriate care (including pulse oximetry and oxygen) and at what points in time and location could pulse oximetry and oxygen be used better for emergency care of children? Setting and Population: facilities are same as sub-study 2). Children (\<15 years, including neonates) presenting with each of 4 acute illness syndromes: (i) pneumonia, (ii) other acute illness with WHO emergency signs, (iii) surgical conditions, and (iv) neonatal illness. Analysis/outcomes: Patient journey maps. Sub-study 4: Research question: How do healthcare workers use pulse oximetry and oxygen for admitted patients, and how does this change over time and vary between patient groups, facility type, and location? How do practices compare with treatment guidelines and where are the priority areas for improving oxygen care? Population and setting: Facilities are same as sub-studies 2\&3. Analysis/outcomes: Narrative descriptions of handover, ward rounds, and nursing rounds, with specific emphasis on how pulse oximetry is used, and decision making for oxygen therapy. Sub-study 5: Indepth interviews and focus group discussions Research questions: 5a) How do patients/caregivers perceive pulse oximetry and oxygen therapy within their broader care experience? 5b) How do healthcare workers, managers and technicians perceive oxygen therapy and the provision of oxygen-related care within the broader care provision experience? Population: * Patients and caregivers enrolled in sub-study 3 (patient journey mapping). * Healthcare workers (bedside), managers (including clinical and non-clinical managers) and technicians in each health facility. We will select staff with direct responsibility for wards caring for children \<15 years. Analysis/outcomes: Reflexive thematic analysis of interviews and focus group discussions.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Makerere University: collaborator
• University of Health Sciences Lao PDR: collaborator
• University of Health Sciences, Cambodia: collaborator
• Clinton Health Access Initiative, Nigeria: collaborator
• Clinical and Public Health Services at Ministry of Health Rwanda: collaborator
• University of Ibadan: collaborator
• Karolinska Institutet: collaborator

Study Sites (3)

10 Facilities to Be Selected

Phnom Penh, Cambodia

RECRUITING

10 Facilities to Be Selected

Ibadan, Nigeria

ACTIVE NOT RECRUITING

10 Facilities to Be Selected

Kampala, Uganda

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Hypoxia; Infant, Newborn, Diseases; Pneumonia; Sepsis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Study Officials

• Hamish Graham, PhD

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

• Carina King, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rami Subhi, FRACP

CONTACT

+61403151186; rami.subhi@mcri.edu.au

Hamish Graham, PhD

CONTACT

+61403456262; hamish.graham@rch.org.au

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 17, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Determined by local countries CHAI offices and MoH

Locations

CA (1); UG (1); NG (1)