Hypothermia and the Effect of Ambient Temperature
HEAT
The Impact of Ambient Operative Room Temperature on Neonatal and Maternal Hypothermia
1 other identifier
interventional
846
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Shorter than P25 for not_applicable
1 active site
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
January 30, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMay 11, 2016
May 1, 2016
6 months
January 30, 2015
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
neonatal hypothermia
a core temperature of less than 36.5C
up to 2 hours following delivery
Secondary Outcomes (1)
maternal hypothermia
up to 10 hours following delivery
Other Outcomes (1)
neonatal hypoglycemia
up to 8 hours following delivery
Study Arms (2)
Ambient Temperature of 67F
NO INTERVENTIONThese patients will have an operating room temperature of 67F for cesarean delivery, the standard of care at our institution.
Ambient Temperature of 73F
ACTIVE COMPARATORThese patient will have an operating room temperature of 73F for cesarean delivery, a temperature more consistent with WHO recommendations.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow Physician
Study Record Dates
First Submitted
January 30, 2015
First Posted
May 6, 2015
Study Start
February 1, 2015
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
May 11, 2016
Record last verified: 2016-05