RECRUITING

Pediatric Adhesion and New Dermal Approach Study

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Conditions

SyncopePediatricCongenital AthymiaCongenital Heart DiseaseArrhythmiaArrhythmia in ChildrenPediatricsPANDA StudyZio monitorChildren

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality. The Zio® monitor (Study Device) is an adhesive patch that is worn on the upper left chest for a specified period of time and is similar to a band aid. The Study Device contains a battery-powered heart monitor and will look at the heart rhythm and rate.

Official Title

Pediatric Adhesion and New Dermal Approach Study (PANDA)

Quick Facts

Study Start:2025-08-15
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07118124

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.

Ages Eligible for Study:1 Year to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Child is \<18 years of age and ≥1 year of age and weighing \>10 kg (22 pounds) at the time of device application.
  2. 2. Child's legally authorized representative is willing and able to provide informed consent and be able to assist the Child in completing all visits for the study. If the Child is old enough to provide assent, it will also be captured.
  3. 3. The prescribed Zio monitor wear time is planned to be up to 14 days.
  1. 1. Child has a known allergy to adhesives or hydrogels or with family history of adhesive skin allergies.
  2. 2. Child has a visible skin injury or broken skin at location for study device placement.
  3. 3. Child has skin damage and a discharge of clear fluid or pus at the location for study device placement.
  4. 4. Child is unable or unwilling to participate or comply with study protocol.
  5. 5. The local Investigator deems the Child has a condition that could limit the Child's ability or willingness to participate in the study, or ability to comply with study required procedures and/or follow-up visits. (It is understood that younger age groups of children may present development behavioral challenges in compliance with use of medical devices. Normal development stage should not be considered a reason for exclusion).
  6. 6. The child has experienced symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the child or when real-time or in-patient monitoring should be prescribed.
  7. 7. Child has an external or wearable cardiac defibrillator or may be exposed to high frequency surgical equipment near strong magnetic fields or devices such as MRI during the wear period.
  8. 8. Child has a neuro-stimulator, as it may disrupt the quality of ECG data.

Contacts and Locations

Study Contact

Adina Sr. Clinical Research Project Manager
CONTACT
(888) 693-2401
adina.muresan@irhythmtech.com
Janet Sr. Clinical Research Project Manager
CONTACT
(888) 693-2401
janet.flores@irhythmtech.com

Principal Investigator

Charles Berul, MD
PRINCIPAL_INVESTIGATOR
Children's National

Study Locations (Sites)

Children's National Hospital
Washington D.C., District of Columbia, 20010
United States
St. Luke's Children's Hospital
Boise, Idaho, 83712
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
WashU Medicine
St Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: iRhythm Technologies, Inc.

  • Charles Berul, MD, PRINCIPAL_INVESTIGATOR, Children's National

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 Registration Dates

Study Start Date2025-08-15
Study Completion Date2025-11

Study Record Updates

Study Start Date2025-08-15
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

  • Pediatrics
  • PANDA Study
  • Zio monitor
  • Children
  • arrhythmia in children

Additional Relevant MeSH Terms

  • Syncope
  • Pediatric
  • Congenital Athymia
  • Congenital Heart Disease
  • Arrhythmia
  • Arrhythmia in Children