Impact of Heart Rate Characteristics Monitoring in Neonates (HeRO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00307333|
Recruitment Status : Completed
First Posted : March 27, 2006
Results First Posted : May 17, 2013
Last Update Posted : May 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Device: HeRO heart rate characteristics monitor||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||3003 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Heart Rate Characteristics Monitoring in Neonates|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||May 2011|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307333
|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|