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Hypothermia and the Effect of Ambient Temperature 2

NCT03008577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5221

Last updated 2018-10-15

No results posted yet for this study

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.

Conditions

  • Hypothermia
  • Neonatal Outcome
  • Cesarean Section

Interventions

OTHER

Change in ambient operating room temperature

Sponsors & Collaborators

  • Parkland Health and Hospital System

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03008577 on ClinicalTrials.gov