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Impact of Heart Rate Characteristics Monitoring in Neonates (HeRO)

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Medical Predictive Science Corporation
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT00307333
First received: March 24, 2006
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Sepsis
 Device: HeRO heart rate characteristics monitor

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight Sepsis
U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Number of Ventilator-free Days [ Time Frame: 120 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3003
Study Start Date: August 2005
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 32 Weeks
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307333

Locations
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
Principal Investigator: Joseph R Moorman, MD University of Virginia
  More Information

No publications provided by University of Virginia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT00307333     History of Changes
Other Study ID Numbers: 10845
Study First Received: March 24, 2006
Results First Received: April 3, 2012
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
very low birth weight infants
heart rate characteristics

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013