Comparison of Three Methods of Taking Temperatures in the Newborn Intensive Care Unit

This study has been withdrawn prior to enrollment.
(This study was closed due to ongoing logistical problems that could not be resolved.)
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01012128
First received: November 9, 2009
Last updated: February 21, 2011
Last verified: February 2011
  Purpose

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.


Condition
Thermometry

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of Temporal Artery, Axillary, and Rectal Temperatures in Preterm Infants in the NICU

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Accuracy of temporal artery thermometer measurements [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Preterm infants corrected to 30-35 weeks gestation

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • infants <30 and >35 weeks gestation
  • infants requiring > 30 degrees centigrade in incubator on air control
  • infants currently not in an incubator
  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: NCT01012128

Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Michael F Bruno, MD Christiana Hospital / Christiana Care Health System
  More Information

No publications provided

Responsible Party: Michael F. Bruno, MD, Christiana Care Health System
ClinicalTrials.gov Identifier: NCT01012128     History of Changes
Other Study ID Numbers: 600687
Study First Received: November 9, 2009
Last Updated: February 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Temporal Artery Thermometer
Temperature
Preterm Infants

ClinicalTrials.gov processed this record on October 23, 2014