Premature BirthNCT02865070
A Smart, "Always -On" Health Monitoring System
An observational study of Premature Birth, run by Northwestern University at 1 site in United States.
Trial summary
This is a pilot study is to test a wireless, skin-sensor device against current technology in the NICU to monitor vitals Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Skin Sensor
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 10 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Smart, "Always -On" Health Monitoring System, Sub-Study: No Strings Attached: Wireless Sensor Technology in the Prentice NICU
This is a pilot study is to test a wireless, skin-sensor device against current technology in the NICU to monitor vitals
Read the detailed description
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.
- Conditions
- Premature Birth
- Being tested
- Skin Sensor
- Keywords
- premature, wireless vitals, vitals monitor
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin SensorDevice
Wireless vitals monitor
| Study group | Role | What they receive |
|---|---|---|
| 2 infants (ages 1-6mo) non-NICU setting | Not described Receives: Device: Skin Sensor | |
| 10 babies (full term, ages 37-42 weeks) | Not described Receives: Device: Skin Sensor | |
| 5 babies (premature, ages 34-37 weeks) | Not described Receives: Device: Skin Sensor | |
| 5 babies (premature, ages 31-34 weeks) | Not described Receives: Device: Skin Sensor | |
| 5 babies (premature, ages 28-31 weeks) | Not described Receives: Device: Skin Sensor | |
| 5 babies (premature, ages 25-28 weeks) | Not described Receives: Device: Skin Sensor | |
| 5 babies (premature, ages 23-25 weeks) | Not described Receives: Device: Skin Sensor | |
| 30 babies (any gestational age under 6 months) | Not described Receives: Device: Skin Sensor | |
| 25 neonates (ages 24-29 weeks for sub-study) | Not described Receives: Device: Skin Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of vital parameters against current technology
Measured: 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
Measured: 24 hours, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startMar 2016
- Primary completion31 Aug 2019
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Paller, Northwestern University
- Investigators
- Amy Paller, MD, Principal investigator, Northwestern University, Lurie Children's Hospital Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865070
- Sponsor's protocol ID
- MA06072012
- Status last verified
- Jun 2022
- First submitted
- 9 Aug 2016
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smart, "Always -On" Health Monitoring System, Sub-Study: No Strings Attached: Wireless Sensor Technology in the Prentice NICU
- ClinicalTrials.gov ID
- NCT02865070
- Acronym / sponsor ID
- MA06072012
- Conditions
- Premature Birth
- Keywords
- premature, wireless vitals, vitals monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study is to test a wireless, skin-sensor device against current technology in the NICU to monitor vitals
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin SensorWireless vitals monitor | Device | 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) |
Primary outcome
Correlation of vital parameters against current technology
Time frame: 15 min, 3 hours, 24 hours, 1 week
1 secondary outcome
Adverse events from wireless monitoring sensor assessed through Neonatal Skin Condition Score (NSCS)-sub-study only
Time frame: 24 hours, 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Paller, MD principal investigator
Northwestern University, Lurie Children's Hospital Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of vital parameters against current technology (time frame: 15 min, 3 hours, 24 hours, 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.