TerminatedNot Applicable

Innovative Central Line Securement Device in the Pediatric Population

Stopped: Unable to meet enrollment targets

United States23 participantsStarted 2020-11-05

Plain-language summary

This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a traditional securement device (dressing).

Who can participate

Age range

0 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with a central line ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study. Exclusion Criteria: * Those children who currently wear a central line securement device (vest) * Children with central lines who are 19 years or older * Those females with central lines and Tanner 2 breast or greater breast development as a wearable central line securement device (vest) will not fit properly to secure the central line and may increase the risk of the central line complications. * If the patient does develop breast during the time of the study then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. The investgators will still collect data on that patient and they will be evaluated in the device arm consistent with the intention to treat principle.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Outcome - Line Breaks

Timeframe: For a maximum of 1 year from enrollment

Primary Outcome - Line Replacement

Timeframe: For a maximum of 1 year from enrollment

Primary Outcome - Line Infections

Timeframe: For a maximum of 1 year from enrollment

Trial details

NCT IDNCT04522778

SponsorRyan St. Pierre-Hetz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-15

Results submitted2023-09-07

View on ClinicalTrials.gov More Central Line Complication trials

Who can participate

Age range

0 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.