Impact of Heart Rate Characteristics Monitoring in Neonates (HeRO)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Impact of Heart Rate Characteristics Monitoring in Neonates|
- Number of Ventilator-free Days [ Time Frame: 120 days ] [ Designated as safety issue: No ]
- Duration of Hospital Stay [ Time Frame: 120 days ] [ Designated as safety issue: No ]
- Days on Antibiotics [ Time Frame: 120 days ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 120 days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||May 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
Device: HeRO heart rate characteristics monitor
24 hour continuous HRC monitoring with display
No Intervention: 2
Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
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.
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33101|
|Winnie Plamer Hospital for Women and Babies|
|Orlando, Florida, United States, 32806|
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Pennsylvania|
|Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|United States, South Carolina|
|Greenville Hospital System|
|Greenville, South Carolina, United States, 29617|
|United States, Tennessee|
|Vanderbilt Children's Hospital|
|Nashville, Tennessee, United States, 37232|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Joseph R Moorman, MD||University of Virginia|