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Completed

NCT Number: NCT02436382

Hypothermia and the Effect of Ambient Temperature

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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Key information

Conditions

Hypothermia Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

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 "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.

Treatment and study plan

change in temperature

Other

increase in ambient room temperature

Primary outcomes

  1. neonatal hypothermia

    Time frame: up to 2 hours following delivery

    a core temperature of less than 36.5C

Secondary outcomes

  1. maternal hypothermia

    Time frame: up to 10 hours following delivery

    an oral temperature of less than 36.5C

Other outcomes

  1. neonatal hypoglycemia

    Time frame: up to 8 hours following delivery

    hypoglycemia requiring treatment

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Acronym: HEAT

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 6, 2015
Registry last updated
May 11, 2016

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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