Heart FailureNCT05961176
Exploratory Study on Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Acute and Critical Care Setting
An observational study of Heart Failure, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The primary research objective is to determine the safety, feasibility, usability and validity of textile-enabled monitoring systems designed to capture physiologic variables, or "biological signals," related to cardiopulmonary function in children through comparison to hospital-based, standard-of-care monitoring in… Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Skiin pediatric band and Skiin biometric pod
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2024to 30 Dec 2027
- Phase
- Observational
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 month to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Infants and Children Admitted to the Cardiac Critical Care Unit
Who may be able to join
- 1. Patients from 1 month of age to 12 years of age who are admitted to SickKids CCCU with expected stays in CCCU longer than 12 hours including those for medical management and post-surgical patients.
Who cannot join
- Any existing condition, diagnosis or physiologic state, in the opinion of the principal investigator, Co-Investigators or most responsible physicians, in which presence of the study monitoring system may have negative effects on patient status or may impair care delivered by the treating team (e.g. hemodynamic instability, at risk for acute deterioration in condition).
- Patients with active wounds or devices (such as a chest tube or invasive lines) in areas that prohibit placement of all configurations of textile device. *
- Patients with Methicillin-Resistant Staphylococcus aureus (MRSA) that represent an infection control risk.
- Patients cannulated to extracorporeal membrane oxygenation (ECMO).
- Patients with imaging/procedures scheduled outside of the CCCU within the 12 hours following eligibility assessment. **
- Patients with an implanted cardioverter defibrillator (ICD)
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- Patients with a pacemaker, either implanted or temporary (temporary pacing wires not in use are allowed). ***
- Patients whose chest/abdomen size is too large or small to fit the available sizes of the Skiin Pediatric Band.
- Eligibility may be reassessed once an appropriate body location for the textile placement becomes available.
- Eligibility may be reassessed after the patient returns to the CCCU.
- Eligibility may be reassessed after the temporary pacemaker has been removed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aamir Jeewa, MD contact
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8
Adrien D'Alonzo, 416-813-7500 ext. 228624, adrien.dalonzo@sickkids.ca
Diana Balmer-Minnes, 416-813-7500 ext. 228624, diana.balmer-minnes@sickkids.ca
About this study
Official title: Exploratory Study on Bio-Signal Telemonitoring Using Electronic Textiles in a Pediatric Acute and Critical Care Setting
The primary research objective is to determine the safety, feasibility, usability and validity of textile-enabled monitoring systems designed to capture physiologic variables, or "biological signals," related to cardiopulmonary function in children through comparison to hospital-based, standard-of-care monitoring in the Sickkids Cardiac Critical Care Unit (CCCU).
Read the detailed description
This single-arm, non-randomized study is a usability, technology feasibility and data correlation study which will employ a convenience sampling method. The study will compare the quality of data obtained by the Myant Inc Skiin Pediatric Band smart textile device to the gold-standard data generated by the clinical devices in the CCCU at SickKids.
The primary research objective is to determine the safety, feasibility, usability and validity of textile-enabled monitoring systems designed to capture physiologic variables, or "biological signals," related to cardiopulmonary function in children through comparison to hospital-based, standard-of-care monitoring in the SickKids CCCU.
The secondary objectives are as follows; (1) To design textiles for infants and children that allow safe, developmentally appropriate care, (2) To investigate the optimum placement of biosensors to measure physiologic parameters such as heart and respiratory rate within the textile-based approach, (3) To validate the textile-based approach, including the integrated sensors, through comparison to physiologic data gathered as part of routine patient care through traditional comparative analysis, (4) To investigate usability of the textiles, including placement, removal, and effects on patient care activities, and (5) To gather clinician feedback on the textile use and design.
- Conditions
- Heart Failure
- Being tested
- Skiin pediatric band and Skiin biometric pod
- Keywords
- Wearable Electronic Device, Cardiovascular Disease, Critical Care, Pediatric
- Medical subject headings
- Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skiin pediatric band and Skiin biometric podDevice
Infants that meet the inclusion criteria will be equipped with a Skiin pediatric band appropriate for their chest size. Heart rate, respiratory rate, temperature, and electrocardiogram will be monitored from 2 to 12 hours through the Skiin pediatric band and a standard of care device (Phillips Intellivue MX750) commonly used in the CCCU at SickKids.
| Study group | Role | What they receive |
|---|---|---|
| Infants and Children Admitted to the CCCU at SickKids | Inclusion Criteria: Patients from 1 month of age to 12 years of age who are admitted to SickKids CCCU with expected stays in CCCU longer than 12 hours including those for medical management and post-surgical patients. Receives: Device: Skiin pediatric band and Skiin biometric pod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
The difference between heart rate measured from Skiin data and from standard of care device.
Measured: collection during the single study session of 2-12 hours.
Respiratory Rate
The difference between respiratory rate measured from Skiin data and from standard of care device.
Measured: collection during the single study session of 2-12 hours.
Temperature
The difference between temperature measured from Skiin data and from standard of care device.
Measured: collection during the single study session of 2-12 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start17 Jan 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Myant Medical Corp.
- Responsible party
- Principal investigator, Aamir Jeewa, The Hospital for Sick Children
- Investigators
- Aamir Jeewa, MD, Principal investigator, The Hospital for Sick ChildrenMichael-Alice Moga, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961176
- Sponsor's protocol ID
- 1000079180
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andrews RE, Fenton MJ, Ridout DA, Burch M; British Congenital Cardiac Association. New-onset heart failure due to heart muscle disease in childhood: a prospective study in the United kingdom and Ireland. Circulation. 2008 Jan 1;117(1):79-84. doi: 10.1161/CIRCULATIONAHA.106.671735. Epub 2007 Dec 17.
PubMed 18086928Wilkinson JD, Landy DC, Colan SD, Towbin JA, Sleeper LA, Orav EJ, Cox GF, Canter CE, Hsu DT, Webber SA, Lipshultz SE. The pediatric cardiomyopathy registry and heart failure: key results from the first 15 years. Heart Fail Clin. 2010 Oct;6(4):401-13, vii. doi: 10.1016/j.hfc.2010.05.002.
PubMed 20869642Kay JD, Colan SD, Graham TP Jr. Congestive heart failure in pediatric patients. Am Heart J. 2001 Nov;142(5):923-8. doi: 10.1067/mhj.2001.119423. No abstract available.
PubMed 11685182Nandi D, Rossano JW. Epidemiology and cost of heart failure in children. Cardiol Young. 2015 Dec;25(8):1460-8. doi: 10.1017/S1047951115002280.
PubMed 26675591Jacob E, Duran J, Stinson J, Lewis MA, Zeltzer L. Remote monitoring of pain and symptoms using wireless technology in children and adolescents with sickle cell disease. J Am Assoc Nurse Pract. 2013 Jan;25(1):42-54. doi: 10.1111/j.1745-7599.2012.00754.x. Epub 2012 Jul 12.
PubMed 23279278Zartner P, Handke R, Photiadis J, Brecher AM, Schneider MB. Performance of an autonomous telemonitoring system in children and young adults with congenital heart diseases. Pacing Clin Electrophysiol. 2008 Oct;31(10):1291-9. doi: 10.1111/j.1540-8159.2008.01180.x.
PubMed 18811810Zartner PA, Toussaint-Goetz N, Photiadis J, Wiebe W, Schneider MB. Telemonitoring with implantable electronic devices in young patients with congenital heart diseases. Europace. 2012 Jul;14(7):1030-7. doi: 10.1093/europace/eur434. Epub 2012 Feb 2.
PubMed 22308087Ware P, Ross HJ, Cafazzo JA, Laporte A, Seto E. Implementation and Evaluation of a Smartphone-Based Telemonitoring Program for Patients With Heart Failure: Mixed-Methods Study Protocol. JMIR Res Protoc. 2018 May 3;7(5):e121. doi: 10.2196/resprot.9911.
PubMed 29724704