Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000885493
Ethics application status
Approved
Date submitted
19/06/2025
Date registered
13/08/2025
Date last updated
13/08/2025
Date data sharing statement initially provided
13/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Midlines Across Paediatrics in Healthcare; Comparing longer IV catheters (midlines) to standard IV catheters and the impact on pain and complications in hospitalised children
Scientific title
Midlines Across Paediatrics (MAP): A step-wedge cluster randomised trial on the efficacy of midline catheter implementation project across regional and tertiary paediatrics in the prevention of peripheral intravenous catheter harm
Secondary ID [1] 314378 0
NH&MRC Partnership Project ID: 2040450
Universal Trial Number (UTN)
Trial acronym
MAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous injuries (related to intravenous catheters) 337378 0
Condition category
Condition code
Public Health 333757 333757 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the implementation of midline catheter implementation as opposed to standard PIVC practice for children 0-18 years requiring peripherally compatible IV therapy.
Delivered once per patient episode by trained nurses/doctors.

Stepped-wedge design: 5 months usual care, 2 months transition - education on midline insertion provided by Nurse Practitioner Vascular Access, and research team members, during one off site visit and online follow-up as required, The exact educational components to be delivered as the intervention will be determined during the co-design phase, to be finalised at least 2 weeks prior to the start of the transition period and may include instructional videos of midline catheter applications and instruction manuals.

5 months intervention per site (12 months total per site). Ten sites staggered over 20 months study-wide. Co-design Phase 1 (3 months) will occur during the control period (usual care) and involves stakeholder surveys, focus groups, and consensus meetings once per month to adapt implementation and operational strategies locally. Adherence monitored via monthly audits of hospital records, competency assessments, and real-time feedback systems. After agreement by all focus groups and local stakeholders, we will then proceed to the feasibility study.

Phase 2 stepped wedge RCT of implementation to be completed within 24 months (with each site participating for 16 months total).

Phase 3 (national toolkit development) commences 3 months after the completion of Phase 2.
Intervention code [1] 331058 0
Treatment: Devices
Intervention code [2] 331059 0
Prevention
Comparator / control treatment
Standard PIVC practice per existing site. Includes: PIVC insertion by trained staff, standard maintenance care, device replacement when complications occur, and usual clinical decision-making without systematic midline consideration. Practices may vary across sites based on local guidelines, resources, staff training, and institutional policies. Each site experiences both control and intervention periods with different patient participants in each phase.
Control group
Active

Outcomes
Primary outcome [1] 341441 0
Adoption
Timepoint [1] 341441 0
Monthly from intervention establishment to the end of the intervention exposure period for each site
Primary outcome [2] 341442 0
Peripheral Intravenous Venous Catheter (PIVC) failure.
Timepoint [2] 341442 0
At time of removal of PIVC
Primary outcome [3] 342031 0
Midline failure
Timepoint [3] 342031 0
At time of removal of midline
Secondary outcome [1] 447512 0
Procedural Pain
Timepoint [1] 447512 0
Immediate measurement following successful insertion of device (relevant to age and development)
Secondary outcome [2] 447513 0
Procedural distress
Timepoint [2] 447513 0
Immediate measurement following successful insertion of device (relevant to age and development)
Secondary outcome [3] 447514 0
Number of insertion attempts
Timepoint [3] 447514 0
Measured at time of insertion of device
Secondary outcome [4] 447515 0
Additional devices required
Timepoint [4] 447515 0
Measured after therapy completion
Secondary outcome [5] 447516 0
Device dwell
Timepoint [5] 447516 0
Measured at time of device removal
Secondary outcome [6] 447536 0
Acceptability - Satisfaction
Timepoint [6] 447536 0
During intervention period (1-5months since commencement of implementation phase)
Secondary outcome [7] 447537 0
Appropriateness - Relevance & usefulness of midline catheters
Timepoint [7] 447537 0
During intervention period (1-5months since commencement of implementation phase)
Secondary outcome [8] 447538 0
Feasibility - Practicality of midlines across paediatrics
Timepoint [8] 447538 0
Post completion of the intervention exposure period at each site
Secondary outcome [9] 447539 0
Sustainability - Midline catheter utility
Timepoint [9] 447539 0
3 months post completion of the intervention exposure period at each site
Secondary outcome [10] 447540 0
Cost of implementation, health services.
Timepoint [10] 447540 0
During the implementation phase (1-5months since commencement of implementation phase)
Secondary outcome [11] 448790 0
Fidelity
Timepoint [11] 448790 0
Monthly from intervention establishment to the end of the intervention exposure period for each site

Eligibility
Key inclusion criteria
Based on clinical trial and practice guidelines, midline catheters will be recommended for children requiring peripherally compatible intravenous therapy. Specific diagnostic or health service-related criteria relevant to individual sites, settings and resources will be tailored.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Each site will develop their own specific exclusion criteria. Exclusion criteria will be co-developed with individual sites in Phase 1 co-design process, based on specific diagnostic or health service-related criteria relevant to local settings and resources.

Over-arching exclusion criteria to be applied:
- Children outside 0-18years,
- Peripheral incompatible therapies
- Active skin infection at insertion sites
- Severe bleeding disorder

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All sites will receive the intervention, with the timing of the stepped-wedge cluster randomised trial (SWCRT) entry randomised using an interactive web-based randomisation program (Griffith University).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Hospital clusters randomised to timing of intervention commencement in stepped-wedge design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Cost-effectiveness analysis using decision analytic model. Between period comparisons of the primary outcome will use a mixed-effects logistic regression model. The main fixed effect included in the model will be study period, with calendar time included as a covariable. Site will be included as a random effect to account for possible non-independence of observations within clusters. Continuous secondary outcomes will be compared with mixed-effects linear regression, and count outcomes by mixed-effects Poisson regression. All models will account for clustering by site. Individual device will be the unit of analysis. The primary analysis of all endpoints will be ‘intention-to- treat’ (ITT), with ‘per protocol’ (PP) analyses assessing the effect of protocol compliance. Missing values will not be imputed but will be considered through the mixed-effects modelling approach, which assumes a missing at random mechanism. Sensitivity analyses will consider models assuming a ‘missing not at random’ mechanism, such as shared parameter models. Two-tailed p-values of <0·05 will be considered as statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2026
Actual
Date of last participant enrolment
Anticipated
1/06/2028
Actual
Date of last data collection
Anticipated
30/11/2028
Actual
Sample size
Target
3588
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC

Funding & Sponsors
Funding source category [1] 318897 0
Government body
Name [1] 318897 0
National Health and Medical Research Council
Country [1] 318897 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 321360 0
None
Name [1] 321360 0
Address [1] 321360 0
Country [1] 321360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317512 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 317512 0
Ethics committee country [1] 317512 0
Australia
Date submitted for ethics approval [1] 317512 0
11/04/2025
Approval date [1] 317512 0
04/06/2025
Ethics approval number [1] 317512 0
HREC/25/QCHQ/117595

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

Contacts
Principal investigator
Name 141282 0
Prof Amanda Ullman
Address 141282 0
Children’s Health Queensland Hospital and Health Service, Level 7, Centre for Children’s Health Research, 62 Graham Street, South Brisbane QLD 4101
Country 141282 0
Australia
Phone 141282 0
+610730697238
Fax 141282 0
Email 141282 0
[email protected]
Contact person for public queries
Name 141283 0
Amanda Ullman
Address 141283 0
Children’s Health Queensland Hospital and Health Service, Level 7, Centre for Children’s Health Research, 62 Graham Street, South Brisbane QLD 4101
Country 141283 0
Australia
Phone 141283 0
+610730697238
Fax 141283 0
Email 141283 0
[email protected]
Contact person for scientific queries
Name 141284 0
Amanda Ullman
Address 141284 0
Children’s Health Queensland Hospital and Health Service, Level 7, Centre for Children’s Health Research, 62 Graham Street, South Brisbane QLD 4101
Country 141284 0
Australia
Phone 141284 0
+610730697238
Fax 141284 0
Email 141284 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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
No additional documents have been identified.