Midline Catheter Study

May 27, 2026 updated by: Children's Hospital of Fudan University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

428

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 201102
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with indwelling mini midline catheters during hospitalization

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric patients aged 1 day to 18 years who require midline catheter placement
Device: Mini 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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/infiltration
Time Frame: Catheter dwell time (from placement to removal; maximum follow-up: 30 days)
Catheter dwell time (from placement to removal; maximum follow-up: 30 days)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Collaborators

First Affiliated Hospital Xi'an Jiaotong University
Jiangxi Province Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CHFudanU0113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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