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Hypothermia and the Effect of Ambient Temperature

The Impact of Ambient Operative Room Temperature on Neonatal and Maternal Hypothermia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02436382
Acronym
HEAT
Enrollment
846
Registered
2015-05-06
Start date
2015-02-28
Completion date
2015-09-30
Last updated
2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia

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.

Interventions

OTHERchange in temperature

increase in ambient room temperature

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
neonatal hypothermiaup to 2 hours following deliverya core temperature of less than 36.5C

Secondary

MeasureTime frameDescription
maternal hypothermiaup to 10 hours following deliveryan oral temperature of less than 36.5C

Other

MeasureTime frameDescription
neonatal hypoglycemiaup to 8 hours following deliveryhypoglycemia requiring treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026