Impact of Heart Rate Characteristics Monitoring in Neonates - Full Text View

Sponsors and Collaborators:	University of Virginia National Institutes of Health (NIH)
Information provided by:	University of Virginia
ClinicalTrials.gov Identifier:	NCT00307333

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:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Impact of Heart Rate Characteristics Monitoring in Neonates

Resource links provided by NLM:

MedlinePlus related topics: 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 ]

Estimated Enrollment:	3000
Study Start Date:	August 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: No Intervention 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

Contacts

Contact: Joseph R Moorman, MD	434-982-3367	rm3h@virginia.edu
Contact: John Kattwinkel, MD	434-924-5428	jk3f@virginia.edu

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Waldemar A Carlo, MD 205-934-4680
Principal Investigator: Waldemar A Carlo, MD
United States, Florida
Winnie Plamer Hospital for Women and Babies	Recruiting
Orlando, Florida, United States, 32806
Contact: Jose Perez, MD 407-649-6939 jose.perez@orhs.org
Principal Investigator: Jose Perez, MD
University of Miami	Recruiting
Miami, Florida, United States, 33101
Contact: Cristina Navarrete, MD 305-585-6408 cnavarrete@med.miami.edu
Principal Investigator: Cristina Navarrete, MD
United States, North Carolina
Wake Forest University Health Sciences	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Michael O'Shea, MD 336-716-2529
Principal Investigator: Micahel O'Shea, MD
United States, Pennsylvania
Milton S. Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Charles Palmer, MD 717-531-8412 copalmer@hmc.psu.edu
Principal Investigator: Charles Palmer, MD
United States, Tennessee
Vanderbilt Children's Hospital	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Steven Steele 615-322-0299 steven.steele@vanderbilt.edu
Principal Investigator: Judy Aschner, MD
United States, Virginia
University of Virginia	Recruiting
Charlottesville, Virginia, United States, 22908
Contact: John Kattwinkel, MD 434-924-5428 jk3f@virginia.edu
Contact: Terri Smoot, RN 434-243-2840 tjs3h@virginia.edu
Principal Investigator: John Kattwinkel, MD

Sponsors and Collaborators

University of Virginia

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Joseph R Moorman, MD

University of Virginia

More Information

No publications provided

Responsible Party:	University of Virginia ( J. Randall Moorman )
Study ID Numbers:	10845
Study First Received:	March 24, 2006
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00307333 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Virginia:

very low birth weight infants
heart rate characteristics

Study placed in the following topic categories:

Body Weight
Birth Weight
Sepsis

ClinicalTrials.gov processed this record on September 11, 2009