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Clinical Trials/NCT01707589
NCT01707589
Unknown
Phase 2

Noninvasive Monitoring of Vital Signs in Neonates

Meir Medical Center1 site in 1 country100 target enrollmentMay 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Admission to the NICU and Need for Physiological Monitoring.
Sponsor
Meir Medical Center
Enrollment
100
Locations
1
Primary Endpoint
Comparison of data collected from ELFI sensor to standard monitors
Last Updated
13 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
October 2014
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Neonates with skin disease

Outcomes

Primary Outcomes

Comparison of data collected from ELFI sensor to standard monitors

Time Frame: 6 months

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.

Study Sites (1)

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