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
  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

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Neonates with skin disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707589

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

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 July 22, 2014