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Device

Wearable Central Line Securement Device (Vest) for Pediatric Disorders

N/A
Waitlist Available
Led By Angelica Mazzarini, MD
Research Sponsored by Ryan St. Pierre-Hetz
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for a maximum of 1 year from enrollment
Awards & highlights

Study Summary

This trial looks at whether a new type of bandage for kids with central lines leads to fewer line complications and a better quality of life, compared to the traditional bandage.

Eligible Conditions
  • Pediatric Disorders
  • Central Line Infection
  • Short Bowel Syndrome
  • Quality of Life
  • Central Line Bloodstream Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for a maximum of 1 year from enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and for a maximum of 1 year from enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
- Line Breaks
- Line Dislodgment
- Line Infections
Secondary outcome measures
Change from baseline in child activity level at 12 months
Change from baseline in child activity level at 3 months
Change from baseline in child activity level at 6 months
+21 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DeviceExperimental Treatment1 Intervention
Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study.
Group II: Traditional Securement DressingActive Control1 Intervention
Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care.

Find a Location

Who is running the clinical trial?

Ryan St. Pierre-HetzLead Sponsor
Angelica Mazzarini, MDPrincipal InvestigatorUPMC Children's Hospital of Pittsburgh

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this research protocol restricted to individuals above a certain age?

"This clinical trial seeks participants who are younger than 18 years old, but have exceeded the age of 0."

Answered by AI

Are there currently any opportunities to join this clinical trial?

"According to clinicaltrials.gov, this medical trial is not presently recruiting participants; the study was initially posted on November 5th 2020 and updated lastly on September 12th 2022. However, there are 1045 other trials actively searching for patients at the moment."

Answered by AI

What are the objectives of this clinical experiment?

"The primary aim of this medical trial, which is designed to be conducted over the course of 12 months from patient enrolment, will measure and assess the frequency of line infections. Additionally, secondary outcomes such as changes in extracurricular activities at 3 months (measured on a 4-category Likert Scale through a modified Baxter Quality of Life questionnaire), sleep quality at 6 months (assessed by same metric) and parental stress at 6 months (also assessed via same mechanism) will be taken into account."

Answered by AI

Do I qualify to become a participant in this clinical research?

"This research initiative has a quota of 200 candidates aged 0 and 18. To be eligible, subjects must never have used any type of central line securement device (vest) before. Additionally, they should also possess satisfactory quality of life (qol)."

Answered by AI
Recent research and studies
Journal of Vascular and Interventional RadiologyJournal
Tunneled Infusion Catheter Breakage: Frequency and Repair Kit Outcomes
Hwang, Freeman R., S. William Stavropoulos, Richard D. Shlansky-Goldberg, Jeffrey I. Mondschein, Aalpen A. Patel, Jeffrey A. Solomon, Maxim Itkin, Michael C. Soulen, Jesse L. Chittams, and Scott O. Trerotola. 2008. “Tunneled Infusion Catheter Breakage: Frequency and Repair Kit Outcomes”. Journal of Vascular and Interventional Radiology. Elsevier BV. doi:10.1016/j.jvir.2007.08.030.
Health and Quality of Life OutcomesJournal
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Burckhardt, Carol S, and Kathryn L Anderson. 2003. “[]”. Health and Quality of Life Outcomes. Springer Science and Business Media LLC. doi:10.1186/1477-7525-1-60.
Journal of Parenteral and Enteral NutritionJournal
Characteristics of a Cohort of Home Parenteral Nutrition Patients at the Time of Enrollment in the Sustain Registry
Winkler, Marion F., Rose Ann DiMaria-Ghalili, Peggi Guenter, Helaine E. Resnick, Lawrence Robinson, Beth Lyman, Carol Ireton-Jones, Lillian Harvey Banchik, and Ezra Steiger. 2016. “Characteristics of a Cohort of Home Parenteral Nutrition Patients at the Time of Enrollment in the Sustain Registry”. Journal of Parenteral and Enteral Nutrition. Wiley. doi:10.1177/0148607115586575.
Pediatric Infectious Disease JournalJournal
Central Venous Catheter Repair Is Associated with an Increased Risk of Bacteremia and Central Line-associated Bloodstream Infection in Pediatric Patients
Lundgren, Ingrid S., Chuan Zhou, Frances R. Malone, Nancy G. Mcafee, Soren Gantt, and Danielle M. Zerr. 2012. “Central Venous Catheter Repair Is Associated with an Increased Risk of Bacteremia and Central Line-associated Bloodstream Infection in Pediatric Patients”. Pediatric Infectious Disease Journal. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/inf.0b013e31823eeec5.
~45 spots leftby Apr 2025
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