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Noninvasive Monitoring of Vital Signs in Neonates

NCT01707589 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-02-12

No results posted yet for this study

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.

Conditions

  • Admission to the NICU and Need for Physiological Monitoring.

Interventions

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.

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Sofia Bauer-rosek, MD · Meir Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-10-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01707589 on ClinicalTrials.gov