Hypothermia and the Effect of Ambient Temperature

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

846 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ambient Temperature of 67F

These patients will have an operating room temperature of 67F for cesarean delivery, the standard of care at our institution.

Group Type NO_INTERVENTION

No interventions assigned to this group

Ambient Temperature of 73F

These patient will have an operating room temperature of 73F for cesarean delivery, a temperature more consistent with WHO recommendations.

Group Type ACTIVE_COMPARATOR

change in temperature

Intervention Type OTHER

increase in ambient room temperature

Interventions

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change in temperature

increase in ambient room temperature

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes