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Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
The primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in infants.
Conditions:
🦠 Congenital Heart Disease in Children
🗓️ Study Start (Actual) 23 May 2023
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 45
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 1 Day to 1 Year (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 9 June 2023
  • First Submitted that Met QC Criteria 9 June 2023
  • First Posted 18 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 June 2024
  • Last Update Posted 28 June 2024
  • Last Verified June 2024
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