Admission to the NICU and Need for Physiological Monitoring. Clinical Trial
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic