Hypothermia and the Effect of Ambient Temperature 2
HEAT2
The Impact of Ambient Cesarean Room Temperature on Neonatal Morbidity
1 other identifier
interventional
5,221
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 28, 2016
CompletedFirst Posted
Study publicly available on registry
January 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedOctober 15, 2018
October 1, 2018
1.7 years
December 28, 2016
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Neonatal Composite Morbidities
Need for respiratory support, Hypoglycemia necessitating treatment, Culture-proven sepsis; Mortality
Up to 24 hours following delivery
Secondary Outcomes (2)
Maternal Recovery Room Dwell Times after Cesarean
Up to 48h following delivery
Maternal Hypothermia
Up to 24 hours after delivery
Study Arms (2)
Ambient operating room temperature of 67°F
NO INTERVENTIONThese patients will have an operating room temperature of 67°F for cesarean delivery, the standard of care at our institution.
Ambient operating room temperature of 75°F
ACTIVE COMPARATORIntervention: Ambient operating room temperature of 75°F for cesarean delivery, which is closer to World Health Organization recommendations.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
Related Publications (1)
Ambia AM, Duryea EL, Wyckoff MH, Tao W, McIntire DD, Seasely AR, Moussa M, Leveno KJ. A Randomized Trial of the Effects of Ambient Operating Room Temperature on Neonatal Morbidity. Am J Perinatol. 2024 May;41(S 01):e1553-e1559. doi: 10.1055/a-2053-7242. Epub 2023 Mar 14.
PMID: 36918157DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2016
First Posted
January 2, 2017
Study Start
August 1, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
October 15, 2018
Record last verified: 2018-10