NCT00760422

Brief Summary

The study is conducted in order to evaluate the performance of the NIT thrmometer by comparing the predictive measurement to equilibrium measurement and to make a final tuning to the thermometer algorithm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 20, 2012

Status Verified

August 1, 2008

Enrollment Period

1.2 years

First QC Date

September 25, 2008

Last Update Submit

April 19, 2012

Conditions

Elevated Temperature

Study Arms (2)

With fever

Device: NIR

Without fever

Device: NIR

Interventions

NIRDEVICE

Thermometer

With feverWithout fever

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

500 patients from both genders, 0-18 years old

You may qualify if:

  • Children 0-18 years old, with or without fever that arrive at the unit of emergency medicine in Schneider medical center.
  • An informed Consent was signed by the patient or his guardian.

You may not qualify if:

  • The medical stuff decides that the patient can't participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

December 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 20, 2012

Record last verified: 2008-08

Locations

IL(1)