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Hypothermia and the Effect of Ambient Temperature 2 (HEAT2)

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ClinicalTrials.gov Identifier: NCT03008577
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
Parkland Health & Hospital System
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The prior HEAT study conducted at our institution showed a difference in neonatal hypothermia with a change in ambient operating room temperature. The investigator's objective is to determine if an increase in ambient operative room temperature decreases the rate of neonatal morbidity. Operating room temperature will be randomized to the current institutional standard of 20°C (67°F) or a temperature of 24°C (75°F), on a weekly basis for a period of 1.2 years.

Condition or disease Intervention/treatment Phase
Hypothermia Neonatal Outcome Cesarean Section Other: Change in ambient operating room temperature Not Applicable

Detailed Description:
This is an open, prospective, randomized, single center trial that will address the primary research question: Does an increase in ambient operating room temperature result in a lower rate of composite neonatal morbidities? During the 1.2 year study period, the operating room temperatures on labor and delivery will be adjusted to either the current standard of care with ambient operating room temperature of 20°C (67°F), or the maximum temperature allowable per hospital policy in the current operating rooms, which is 24°C (75°F), as determined by cluster randomization. Composite neonatal morbidities will be recorded including hypoglycemia necessitating treatment; need for respiratory support within the first 24 hours; culture-proven sepsis; and mortality. Association of outcomes with the types of passive and active warming performed will include these morbidities stratified by gestational age as well as maternal outcomes. In addition, an electronic survey will be administered to the operating resident physicians to assess their experience with the study conditions.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4022 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Ambient Cesarean Room Temperature on Neonatal Morbidity
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
No Intervention: Ambient operating room temperature of 67°F
These patients will have an operating room temperature of 67°F for cesarean delivery, the standard of care at our institution.
Active Comparator: Ambient operating room temperature of 75°F
Intervention: Ambient operating room temperature of 75°F for cesarean delivery, which is closer to World Health Organization recommendations.
Other: Change in ambient operating room temperature



Primary Outcome Measures :
  1. Neonatal Composite Morbidities [ Time Frame: Up to 24 hours following delivery ]
    Need for respiratory support, Hypoglycemia necessitating treatment, Culture-proven sepsis; Mortality


Secondary Outcome Measures :
  1. Maternal Recovery Room Dwell Times after Cesarean [ Time Frame: Up to 48h following delivery ]
  2. Maternal Hypothermia [ Time Frame: Up to 24 hours after delivery ]
    An oral temperature of less than 36.5C



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All pregnant women and their neonates undergoing cesarean delivery by the Parkland Hospital Obstetrics Service on the Labor and Delivery unit during the study period.

Exclusion Criteria:

  • Exclusion criteria include cases where a 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 and resuscitative efforts are not performed ("comfort care only" provided), or a neonatal temperature is not available.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008577


Contacts
Contact: Anne M Ambia, MD anne.ambia@utsouthwestern.edu

Locations
United States, Texas
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: Anne M Ambia, MD       anne.ambia@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Parkland Health & Hospital System

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03008577     History of Changes
Other Study ID Numbers: STU 062016-040
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms