HypothermiaHEAT2NCT03008577
Hypothermia and the Effect of Ambient Temperature 2
A study testing Change in ambient operating room temperature in people with Hypothermia and Neonatal Outcome, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypothermia, Neonatal Outcome, Cesarean Section
- What is being tested?
- Change in ambient operating room temperature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,221 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Ambient Cesarean Room Temperature on Neonatal Morbidity
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.
Read the 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.
- Conditions
- Hypothermia, Neonatal Outcome, Cesarean Section
- Being tested
- Change in ambient operating room temperature
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in ambient operating room temperatureOther
| Study group | Role | What they receive |
|---|---|---|
| Ambient operating room temperature of 67°F | No intervention | These 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 comparator | Intervention: Ambient operating room temperature of 75°F for cesarean delivery, which is closer to World Health Organization recommendations. Receives: Other: Change in ambient operating room temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Composite Morbidities
Need for respiratory support, Hypoglycemia necessitating treatment, Culture-proven sepsis; Mortality
Measured: Up to 24 hours following delivery
Secondary outcomes (2)
Maternal Recovery Room Dwell Times after Cesarean
Measured: Up to 48h following delivery
Maternal Hypothermia
An oral temperature of less than 36.5C
Measured: Up to 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Parkland Health and Hospital System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008577
- Sponsor's protocol ID
- STU 062016-040
- Acronym
- HEAT2
- Status last verified
- Oct 2018
- First submitted
- 28 Dec 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
Publications
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.
PubMed 36918157
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ambient Cesarean Room Temperature on Neonatal Morbidity
- ClinicalTrials.gov ID
- NCT03008577
- Acronym / sponsor ID
- HEAT2 / STU 062016-040
- Conditions
- Hypothermia, Neonatal Outcome, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,221 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Parkland Health and Hospital System
- Study start
- Aug 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambient operating room temperature of 67°F | No intervention | –These 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 comparator | Other: Change in ambient operating room temperatureIntervention: Ambient operating room temperature of 75°F for cesarean delivery, which is closer to World Health Organization recommendations. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change in ambient operating room temperature | Other | Ambient operating room temperature of 75°F |
Primary outcome
Neonatal Composite Morbidities
Time frame: Up to 24 hours following delivery
Need for respiratory support, Hypoglycemia necessitating treatment, Culture-proven sepsis; Mortality
2 secondary outcomes
Maternal Recovery Room Dwell Times after Cesarean
Time frame: Up to 48h following delivery
Maternal Hypothermia
Time frame: Up to 24 hours after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 36918157Ambia 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.
Related trials for Hypothermia
Not yet recruiting
Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
Perioperative Hypothermia, Inadvertent Perioperative Hypothermia
Recruiting
Role of Hypothermia in Endovascular Stroke Thrombectomy
Stroke, Acute Ischemic
Not yet recruiting
Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Acute Ischemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change in ambient operating room temperature in people with Hypothermia and Neonatal Outcome, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Composite Morbidities (time frame: Up to 24 hours following delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03008577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.