Midline Catheter Study

NCT07610681 | Active Not Recruiting DMC

• 1 other identifier: CHFudanU0113
• Study Type: observational
• Target: 428
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Health

Outcome Measures

Primary Outcomes (1)

• 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/infiltration

  Catheter dwell time (from placement to removal; maximum follow-up: 30 days)

Secondary Outcomes (4)

• 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

Study Arms (1)

Pediatric patients aged 1 day to 18 years who require midline catheter placement

Pediatric patients aged 1 day to 18 years who require midline catheter placement

Device: Mini midline catheters

Interventions

Mini midline catheters DEVICE

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.

Pediatric patients aged 1 day to 18 years who require midline catheter placement

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients with indwelling mini midline catheters during hospitalization

You may qualify if:

• Children aged 1 day to 18 years;
• Indwelling midline catheters;
• Legally authorized guardians have signed the informed consent form.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Jiangxi Province Children's Hospital: collaborator

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

Study Design

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

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: May 28, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)