Hypothermia and the Effect of Ambient Temperature 2
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/17/2018 |
| Start Date: | August 2016 |
| End Date: | May 2018 |
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.
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.
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.
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.
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.
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