Hypothermia and the Effect of Ambient Temperature | NCT02436382

Studies
Hypothermia and the Effect of Ambient Temperature

NCT02436382

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

May 11, 2016Estimated

Enrollment

846Actual

Phase

Not Applicable

Conditions

Hypothermia

Interventions

change in temperature

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

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Aug 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jan 30, 2015

First Submission Date that Met QC Criteria

May 1, 2015

First Posted Date

May 6, 2015Estimated

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

May 10, 2016

Last Update Posted Date

May 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elaine Duryea, Fellow Physician, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Not provided

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

Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The investigators objective is to determine if an increase in ambient operative room temperature decreases the rate of hypothermia. Operating room temperature will be randomized to the current institutional standard (67°F) or a temperature of 73°F on a weekly basis for a period of six months.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

846Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ambient Temperature of 67F	No Intervention	These patients will have an operating room temperature of 67F for cesarean delivery, the standard of care at our institution.
Ambient Temperature of 73F	Active Comparator	These patient will have an operating room temperature of 73F for cesarean delivery, a temperature more consistent with WHO recommendations.	Other: change in temperature

Interventions

Name	Type	Description	Arm Group Labels	Other Names
change in temperature	Other	increase in ambient room temperature	Ambient Temperature of 73F

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
neonatal hypothermia	a core temperature of less than 36.5C	up to 2 hours following delivery

Secondary Outcomes

Measure	Description	Time Frame
maternal hypothermia	an oral temperature of less than 36.5C	up to 10 hours following delivery

Other Outcomes

Measure	Description	Time Frame
neonatal hypoglycemia	hypoglycemia requiring treatment	up to 8 hours following delivery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All pregnant women and their neonates undergoing cesarean delivery by the Parkland Hospital Obstetrics Service on the Labor and Delivery "West" Unit (operating rooms 1, 2, 3, and 5) during the study period.

Exclusion Criteria:

Subjects will be excluded from the study if cesarean delivery is planned but a precipitous vaginal delivery occurs, intrauterine fetal demise has been diagnosed prior to start of surgery, the neonate is noted to have a major congenital anomaly, resuscitative efforts are not performed ("comfort care only" provided), or a neonatal temperature is not available.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parkland Memorial Hospital		Dallas	Texas	75235	United States

Condition Browse Module

MeSH Terms

ID	Term
D007035	Hypothermia

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013696	Temperature

Ancestor Terms

ID	Term
D013816	Thermodynamics
D055585	Physical Phenomena
D014887	Weather
D001272	Atmosphere

Browse Leaves

Not provided

Browse Branches

Not provided