Wearable device for monitoring vital signs in infants
Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
This study tests a new wearable device that helps monitor vital signs in infants, especially those with heart problems, to see if it can improve their health and safety at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 1 Day to 1 Year |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05910320 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of a wearable vital sign monitoring device designed for infants, particularly focusing on those with congenital heart disease. The device aims to provide continuous monitoring of critical parameters such as heart rate, respiratory rate, and oxygen saturation outside of traditional healthcare settings. By enabling at-home monitoring, the study seeks to improve clinical outcomes and reduce mortality rates in infants with single ventricle congenital heart disease, while also benefiting healthy infants. The research will involve collecting numerical data and physiological waveforms to assess the device's effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are infants admitted to a newborn nursery, pediatric cardiac intensive care unit, or pediatric care unit.
Not a fit: Patients who are foster children or wards of the state will not be eligible for this study.
Why it matters
Potential benefit: If successful, this device could significantly improve health monitoring and outcomes for infants with congenital heart disease.
How similar studies have performed: Previous studies have shown that remote vital sign monitoring can reduce mortality in infants with congenital heart disease, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient admitted to either the newborn nursery, pediatric cardiac intensive care unit (PCICU), or pediatric care unit (PCU) * Parent provided written informed consent Exclusion Criteria: * Foster or ward of the state
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Children's Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Danielle Gottlieb Sen, MD — Johns Hopkins School of Medicine
- Study coordinator: Kate Calligy, BSN
- Email: kcummi15@jhmi.edu
- Phone: 4432874117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.