A Smart, "Always -On" Health Monitoring System

NCT02865070 | Completed

• 1 other identifier: MA06072012
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Premature Birth

Keywords

premature; wireless vitals; vitals monitor

Outcome Measures

Primary Outcomes (1)

• Correlation of vital parameters against current technology

  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

  24 hours, 1 week

Study Arms (9)

2 infants (ages 1-6mo) non-NICU setting

Device: Skin Sensor

10 babies (full term, ages 37-42 weeks)

Device: Skin Sensor

5 babies (premature, ages 34-37 weeks)

Device: Skin Sensor

5 babies (premature, ages 31-34 weeks)

Device: Skin Sensor

5 babies (premature, ages 28-31 weeks)

Device: Skin Sensor

5 babies (premature, ages 25-28 weeks)

Device: Skin Sensor

5 babies (premature, ages 23-25 weeks)

Device: Skin Sensor

30 babies (any gestational age under 6 months)

Device: Skin Sensor

25 neonates (ages 24-29 weeks for sub-study)

Device: Skin Sensor

Interventions

Skin Sensor DEVICE

Wireless vitals monitor

10 babies (full term, ages 37-42 weeks); 2 infants (ages 1-6mo) non-NICU setting; 25 neonates (ages 24-29 weeks for sub-study); 30 babies (any gestational age under 6 months); 5 babies (premature, ages 23-25 weeks); 5 babies (premature, ages 25-28 weeks); 5 babies (premature, ages 28-31 weeks); 5 babies (premature, ages 31-34 weeks); 5 babies (premature, ages 34-37 weeks)

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Up to 110 premature babies in the Lurie Children's Hospital and Prentice Women's Hospital NICU within 1 week of birth that fall into one of the listed cohorts, fit inclusion and exclusion criteria

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Amy Paller, MD

  Northwestern University, Lurie Children's Hospital Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology and Pediatrics

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: March 1, 2016
• Primary Completion: August 31, 2019
• Study Completion: November 10, 2021
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

US (1)