Noninvasive Monitoring of Vital Signs in Neonates
Recruitment status was Not yet recruiting
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Purpose
the investigators are assessing a non-invasive monitor based on dynamic light scattering that measures pulse rate and respiration rate. The monitor also will be equipped with a temperature sensor and a motion sensor. This monitor will allow multi-parametric measurements in neonates in a simple and noninvasive manner.
| Condition | Intervention | Phase |
|---|---|---|
|
Admission to the NICU and Need for Physiological Monitoring. |
Device: The new sensor is not on the market. We have named it Elfi-sensor. |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
- Comparison of data collected from ELFI sensor to standard monitors [ Time Frame: 6 months ] [ Designated as safety issue: No ]the investigators are comparing the data recoded by the new sensor to that recorded by conventional sensors during a period of one hour in the NICU. The data recorded by the new sensor will not be used for clinical decision making.
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2013 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Neonates admitted to the NICU
Neonates admitted to the NICU for a variety of medical reasons will be the cohort group. Those whose parents give informed consent will compose the subjects of the study
|
Device: The new sensor is not on the market. We have named it Elfi-sensor.
Participating subjects will be monitored for one hour with a noninvasive sensor.The noninvasive sensor, the size of a penny, will be affixed to the skin, above the umbilicus, with pediatric adhesive tape. The monitor will record continuously the heart rate, cardiac rhythm, respiratory rate and body motion.
|
Detailed Description:
Monitoring vital signs in neonates is important. This currently is done with multiple standard clinical monitors. the investigators are developing a very small (coin-sized) sensor that can measure pulse rate, respiratory rate, temperature and body motion. the investigators propose to test our sensor against standard monitoring techniques in neonates in a neonatal ICU (NICU).
The monitor, called ELFI-monitor, is based on dynamic light scattering. A low-power laser beams light into the skin, and the red blood cells in the underlying skin return the light which is recorded in a light sensor. The movement of the red blood cells is affected by the rhythmic cardiac contractility. in this manner, heart rate and rhythm can be assessed. The ELFI monitor also contains an embedded temperature probe and a miniature 3-D motion sensor, allowing capture of additional parameters.
Methods:
the investigators plan to study 100 neonates admitted to the NICU of Meir Hospital Center. These infants are routinely monitored with standard equipment including ECG, oximeter, temperature, and respiratory monitors. the investigators will simultaneously monitor these children with the ELFI monitor, recording pulse rate, cardiac rhythm, respiratory rate, skin temperature and body motion. Recordings will be conducted for a one-hour period on each subject. Data recordings from the ELFI sensor will be compared to the readouts of the conventional monitors used on the patient. It is important to emphasize that the data recordings of the ELFI sensor will not affect clinical decisions in any manner, but will merely be recorded for comparison with conventional sensors.
Eligibility| Ages Eligible for Study: | up to 6 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All neonates admitted the Meir Hospital center NICU
- Parents provide informed consent
Exclusion Criteria:
- Neonates with skin disease
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01707589
| Israel | |
| Neonatal department Meir Medical Center | Not yet recruiting |
| Kfar Saba, Israel | |
| Contact: Sofia Bauer-rosek, MD 09-7471554 bauers@clalit.org.il | |
| Principal Investigator: Sofia Bauer-rosek, MD | |
| Principal Investigator: | Sofia Bauer-rosek, MD | Meir Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Meir Medical Center |
| ClinicalTrials.gov Identifier: | NCT01707589 History of Changes |
| Other Study ID Numbers: | Pediatric Elfi-Monitor |
| Study First Received: | September 10, 2012 |
| Last Updated: | February 11, 2013 |
| Health Authority: | Israel: Local Ethics Commission |
Keywords provided by Meir Medical Center:
|
monitoring heart rate respiration rate temperature |
motion noninvasive physiologic parameters NICU |
ClinicalTrials.gov processed this record on February 27, 2015