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Completed

NCT Number: NCT02865070

A Smart, "Always -On" Health Monitoring System

This is a pilot study is to test a wireless, skin-sensor device against current technology in the NICU to monitor vitals

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

About this study

This is a single center, prospective, observational study that will recruit subjects from Lurie Children's Hospital and Prentice Women's Hospital to test a new wireless vitals monitor against the current vitals monitors used in the NICU. Patients will be neonates in different age brackets.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Neonates in different age cohorts from ages 25 weeks gestational age to fullterm infants or infants up to 6 months of age, selected with assistance of NICU staff
  • Currently in NICU and requiring monitoring for heart rate, ECG, respiratory rate, temperature, and pulse oximetry
  • Parents able to understand and provide informed consent for study
  • Infants enrolled in the Pre-Vent study (sub-study only)

Exclusion criteria

  • Over 6 months of age
  • Hemodynamic or other instability precluding testing of new monitoring with concurrent standards
  • Infants at imminent risk of death and neonates with a skin abnormality that precludes assessment

Treatment and study plan

Skin Sensor

Device

Wireless vitals monitor

Primary outcomes

  1. Correlation of vital parameters against current technology

    Time frame: 15 min, 3 hours, 24 hours, 1 week

Secondary outcomes

  1. Adverse events from wireless monitoring sensor assessed through Neonatal Skin Condition Score (NSCS)-sub-study only

    Time frame: 24 hours, 1 week

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

A Smart, "Always -On" Health Monitoring System, Sub-Study: No Strings Attached: Wireless Sensor Technology in the Prentice NICU

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Aug 12, 2016
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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