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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06087315




Registration number
NCT06087315
Ethics application status
Date submitted
12/10/2023
Date registered
17/10/2023
Date last updated
8/05/2024

Titles & IDs
Public title
Evaluation of a Multi-country Medical Oxygen Program
Scientific title
Realist Evaluation and Learning in a Multi-country Medical OXYgen Program (REAL-MOXY)
Secondary ID [1] 0 0
HREC97817
Universal Trial Number (UTN)
Trial acronym
REAL-MOXY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Experimental: BX-001N Part 2 - Part 2 is MAD with 3 cohorts where each participant will receive 7 sequential daily IV bolus doses following a 8hr fast.
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
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.
Minimum age
0 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Hamish Graham, PhD
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rami Subhi, FRACP
Address 0 0
Country 0 0
Phone 0 0
+61403151186
Fax 0 0
Email 0 0
rami.subhi@mcri.edu.au
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06087315