Noninvasive Monitoring of Vital Signs in Neonates

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Study Start Date :	May 2013
Estimated Primary Completion Date :	October 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	up to 6 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Neonates with skin disease

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Meir Medical Center

Investigators

Principal Investigator:	Sofia Bauer-rosek, MD	Meir Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

Responsible Party:	Meir Medical Center
ClinicalTrials.gov Identifier:	NCT01707589 History of Changes
Other Study ID Numbers:	Pediatric Elfi-Monitor
First Posted:	October 16, 2012
Last Update Posted:	February 12, 2013
Last Verified:	February 2013

Keywords provided by Meir Medical Center:

monitoring; heart rate; respiration rate; temperature	motion; noninvasive; physiologic parameters; NICU