Noninvasive Monitoring of Vital Signs in Neonates

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01707589
First received: September 10, 2012
Last updated: February 11, 2013
Last verified: February 2013

September 10, 2012
February 11, 2013
May 2013
October 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01707589 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Noninvasive Monitoring of Vital Signs in Neonates
Not Provided

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Admission to the NICU and Need for Physiological Monitoring.
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.
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
Intervention: Device: The new sensor is not on the market. We have named it Elfi-sensor.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
Not Provided
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All neonates admitted the Meir Hospital center NICU
  • Parents provide informed consent

Exclusion Criteria:

  • Neonates with skin disease
Both
up to 6 Months
No
Israel
 
NCT01707589
Pediatric Elfi-Monitor
Not Provided
Meir Medical Center
Meir Medical Center
Not Provided
Principal Investigator: Sofia Bauer-rosek, MD Meir Medical Center
Meir Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP