Child HealthNCT07610681
Midline Catheter Study
An observational study of Child Health, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Child Health
- What is being tested?
- Mini midline catheters
- Type of treatment
- Medical device
- How many people
- 428 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients with indwelling mini midline catheters during hospitalization
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Child Health
- Being tested
- Mini midline catheters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini midline cathetersDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Mini midline catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Catheter dwell time (from placement to removal; maximum follow-up: 30 days)
Secondary outcomes (4)
Feasibility: First-attempt puncture success rate (%) ;
Measured: Blood return was achieved smoothly upon completion of the first puncture, within one minute of catheter placement.
Catheterization duration（minutes）
Measured: From initial skin puncture to catheter fixation, assessed intraprocedurally
Catheter dwell time（days)
Measured: From successful catheter placement to removal, maximum follow-up of 30 days
Unplanned extubation rate(%)
Measured: Within 30 days post-insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Mar 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Jiangxi Province Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610681
- Sponsor's protocol ID
- CHFudanU0113
- Status last verified
- May 2026
- First submitted
- 13 Jan 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Cohort Study on the Application of Mini-Midline Catheters in Pediatric Populations
- ClinicalTrials.gov ID
- NCT07610681
- Acronym / sponsor ID
- CHFudanU0113
- Conditions
- Child Health
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Jiangxi Province Children's Hospital
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients aged 1 day to 18 years who require midline catheter placement | – | Device: Mini midline cathetersPediatric patients aged 1 day to 18 years who require midline catheter placement |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients with indwelling mini midline catheters during hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini midline cathetersNo 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. | Device | Pediatric patients aged 1 day to 18 years who require midline catheter placement |
Primary outcome
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)
4 secondary outcomes
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.
Catheterization duration（minutes）
Time frame: 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
Unplanned extubation rate(%)
Time frame: Within 30 days post-insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Health, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.