Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pilot study is to test a wireless, skin-sensor device against current technology in the NICU to monitor vitals
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 infants (ages 1-6mo) non-NICU setting |
| ||
| 10 babies (full term, ages 37-42 weeks) |
| ||
| 5 babies (premature, ages 34-37 weeks) |
| ||
| 5 babies (premature, ages 31-34 weeks) |
| ||
| 5 babies (premature, ages 28-31 weeks) |
| ||
| 5 babies (premature, ages 25-28 weeks) |
| ||
| 5 babies (premature, ages 23-25 weeks) |
| ||
| 30 babies (any gestational age under 6 months) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin Sensor | Device | Wireless vitals monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of vital parameters against current technology | 15 min, 3 hours, 24 hours, 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events from wireless monitoring sensor assessed through Neonatal Skin Condition Score (NSCS)-sub-study only | 24 hours, 1 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amy Paller, MD | Northwestern University, Lurie Children's Hospital Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
| 25 neonates (ages 24-29 weeks for sub-study) |
|
| D000091642 | Urogenital Diseases |