Skip to content

Midline Catheter Study

A Prospective Longitudinal Cohort Study on the Application of Mini-Midline Catheters in Pediatric Populations

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07610681
Enrollment
428
Registered
2026-05-28
Start date
2026-03-01
Completion date
2026-12-30
Last updated
2026-05-28

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

Conditions

Child Health

Brief summary

The purpose of this study is to conduct a prospective longitudinal cohort observational study to analyze the catheterization success rate, catheter dwell time, as well as the incidence and risk factors of related complications in pediatric patients of different age groups; to explore the suitability and application efficacy of this type of catheter in different disease types and treatment scenarios; to optimize the venous access selection strategy for hospitalized pediatric patients, formulate targeted catheterization and maintenance standards, provide theoretical evidence for clinical practice, and improve patients' medical experience.

Interventions

DEVICEMini midline catheters

No intervention. This is a cohort study investigating the applicability and safety of mini midline catheters in pediatric populations. All enrolled children receive standard clinical care for mini midline catheters (including placement, daily maintenance, and removal as indicated) consistent with pediatric vascular access guidelines. The study aims to observe the natural clinical performance of the catheters without any intervention beyond routine clinical management.

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER
First Affiliated Hospital Xi'an Jiaotong University
CollaboratorOTHER
Jiangxi Province Children's Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No

Inclusion criteria

1.Inclusion Criteria: 1. Children aged 1 day to 18 years; 2. Indwelling midline catheters; 3. Legally authorized guardians have signed the informed consent form. 2.

Exclusion criteria

Pediatric patients with vascular access other than indwelling midline catheters.

Design outcomes

Primary

MeasureTime frame
Safety: Midline catheter-related complications and their severity,including: ① Catheter-related bloodstream infection (CRBSI) ② Venous thrombosis ③ Catheter occlusion ④ Phlebitis ⑤ Extravasation/infiltrationCatheter dwell time (from placement to removal; maximum follow-up: 30 days)

Secondary

MeasureTime frame
Feasibility: First-attempt puncture success rate (%) ;Blood return was achieved smoothly upon completion of the first puncture, within one minute of catheter placement.
Catheterization duration(minutes)From initial skin puncture to catheter fixation, assessed intraprocedurally
Catheter dwell time(days)From successful catheter placement to removal, maximum follow-up of 30 days
Unplanned extubation rate(%)Within 30 days post-insertion

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026