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Midlines Across Paediatrics in Healthcare; Comparing longer IV catheters (midlines) to standard IV catheters and the impact on pain and complications in hospitalised children

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000885493
Acronym
MAP
Enrollment
4000
Registered
2025-08-13
Start date
2026-09-01
Completion date
2028-06-01
Last updated
2026-08-24

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

Conditions

None listed

Brief summary

This project aims to effectively and sustainably implement midline catheters across Australian paediatric settings and develop a toolkit that is scalable for national implementation. Our vision is to stop unnecessary PIVC pain, complications and reinsertion for children. Over a four-year period, this three-phase project will first co-design an implementation approach, then implement and evaluate it, and finally utilise the findings to develop a national toolkit for change. Phase 1 Co-design of implementation approach to adapt implementation and operational strategies locally, Phase 2 stepped wedge RCT of implementation across regional and tertiary paediatric hospital/wards (study included in this registration), Phase 3 will develop and disseminate a national toolkit for change.

Interventions

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 c

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.

Sponsors

University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 31, 2026