Status:
COMPLETED
Impact of Heart Rate Characteristics Monitoring in Neonates
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institutes of Health (NIH)
Medical Predictive Science Corporation
Conditions:
Sepsis
Eligibility:
All Genders
1-32 years
Phase:
NA
Brief Summary
Hypothesis: Fewer neonates managed using information from heart rate characteristics (HRC) will require intubation and mechanical ventilation as a result of sepsis and sepsis-like illness. Infants wi...
Detailed Description
Following randomization, infants will be managed as usual practice. The treating physicians of the HRC-display group will be able to utilize the HRC score to assist in the care of the infant. The phys...
Eligibility Criteria
Inclusion
- Infants admitted to NICU
- Birth weight \< 1500 grams
- Gestational age \< or = 32 weeks
- Informed consent obtained from parent
Exclusion
- Evidence of sustained cardiac arrhythmia
- Use of an electronic pacemaker
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
3003 Patients enrolled
Trial Details
Trial ID
NCT00307333
Start Date
August 1 2005
End Date
May 1 2011
Last Update
May 27 2013
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Miami
Miami, Florida, United States, 33101
3
Winnie Plamer Hospital for Women and Babies
Orlando, Florida, United States, 32806
4
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157