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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
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Medical Predictive Science Corporation
Information provided by (Responsible Party):
University of Virginia

Study Description
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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 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

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3003 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Ventilator-free Days [ Time Frame: 120 days ]

Secondary Outcome Measures :
  1. Duration of Hospital Stay [ Time Frame: 120 days ]
  2. Days on Antibiotics [ Time Frame: 120 days ]
  3. Mortality [ Time Frame: 120 days ]

Eligibility Criteria
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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants admitted to NICU
  • Birth weight < 1500 grams
  • Gestational age < or = 32 weeks
  • Informed consent obtained from parent

Exclusion Criteria:

  • Evidence of sustained cardiac arrhythmia
  • Use of an electronic pacemaker
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of Virginia
National Institutes of Health (NIH)
Medical Predictive Science Corporation
Investigators
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Principal Investigator: Joseph R Moorman, MD University of Virginia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT00307333    
Other Study ID Numbers: 10845
First Posted: March 27, 2006    Key Record Dates
Results First Posted: May 17, 2013
Last Update Posted: May 27, 2013
Last Verified: May 2013
Keywords provided by University of Virginia:
very low birth weight infants
heart rate characteristics