Comparison of Three Methods of Taking Temperatures in the... | NCT01012128

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

NCT01012128

Sponsor

Christiana Care Health Services

Status

Withdrawn

Last Update Posted

Apr 6, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Thermometry

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Closed: logistical problems that could not be resolved.

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jan 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Nov 9, 2009

First Submission Date that Met QC Criteria

Nov 10, 2009

First Posted Date

Nov 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2015

Last Update Posted Date

Apr 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Measure	Description	Time Frame
Accuracy of temporal artery thermometer measurements		5 minutes

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

Preterm infants corrected to 30-35 weeks gestation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael F Bruno, MD	Christiana Hospital / Christiana Care Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christiana Hospital		Newark	Delaware	19718	United States