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 will be randomly assigned to one of two groups. One group of infants will have the HRC index known to the physicians caring for them, and physicians will use the HRC index as they desire to aid in clinical management. Infants in the other group will have the HRC index recorded, but this information will not be displayed to the physicians caring for the infants.
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 physicians of the no-display group will provide care as per standard. Clinical symptoms will be treated according to the medical discretion of each physician. Cultures will be obtained and antibiotics administered as per the medical discretion of the physicians. Clinical, culture results, antibiotic administration, ventilator use, and outcome at 120 days data will be collected on the infants as well as their HRC score calculated by the HeRO heart rate characteristics monitor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
3,003
24 hour continuous HRC monitoring with display
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Miami
Miami, Florida, United States
Winnie Plamer Hospital for Women and Babies
Orlando, Florida, United States
Wake Forest University Health Sciences
Number of Ventilator-free Days
Time frame: 120 days
Duration of Hospital Stay
Time frame: 120 days
Days on Antibiotics
Time frame: 120 days
Mortality
Time frame: 120 days
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Winston-Salem, North Carolina, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Greenville Hospital System
Greenville, South Carolina, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
University of Virginia
Charlottesville, Virginia, United States