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Completed

NCT Number: NCT03008577

Hypothermia and the Effect of Ambient Temperature 2

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Change in ambient operating room temperature

Other

Primary outcomes

  1. Neonatal Composite Morbidities

    Time frame: Up to 24 hours following delivery

    Need for respiratory support, Hypoglycemia necessitating treatment, Culture-proven sepsis; Mortality

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Parkland Health and Hospital System

Registry information

Official study title

The Impact of Ambient Cesarean Room Temperature on Neonatal Morbidity

Acronym: HEAT2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 2, 2017
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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