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NCT Number: NCT07610681

Midline Catheter Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Child Health

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, 201102, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

1.Inclusion Criteria:

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

2.Exclusion Criteria: Pediatric patients with vascular access other than indwelling midline catheters.

Treatment and study plan

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.

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

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

Secondary outcomes

  1. 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.

  2. Catheterization duration（minutes）

    Time frame: From initial skin puncture to catheter fixation, assessed intraprocedurally

  3. Catheter dwell time（days)

    Time frame: From successful catheter placement to removal, maximum follow-up of 30 days

  4. Unplanned extubation rate(%)

    Time frame: Within 30 days post-insertion

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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