NCT01012128

Brief Summary

Preterm infants will have their body temperature measured by three different devices in order to evaluate whether the newest device, a temporal artery scanning thermometer, is accurate for patients in the preterm period.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

November 9, 2009

Last Update Submit

April 3, 2015

Conditions

Thermometry

Keywords

Temporal Artery ThermometerTemperaturePreterm Infants

Outcome Measures

Primary Outcomes (1)

  • Accuracy of temporal artery thermometer measurements

    5 minutes

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm infants corrected to 30-35 weeks gestation

You may qualify if:

  • preterm infants corrected to 30-35 weeks gestation
  • current incubator set on air control between 28-30 degrees centigrade

You may not qualify if:

  • infants \<30 and \>35 weeks gestation
  • infants requiring \> 30 degrees centigrade in incubator on air control
  • infants currently not in an incubator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Study Officials

  • Michael F Bruno, MD

    Christiana Hospital / Christiana Care Health System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 11, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

December 1, 2011

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

US(1)