Impact of Heart Rate Characteristics Monitoring in Neonates (HeRO)

May 16, 2013 updated by: University of Virginia

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 Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

3003

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Florida
      • Miami, Florida, United States, 33101
        • University of Miami
      • Orlando, Florida, United States, 32806
        • Winnie Plamer Hospital for Women and Babies
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29617
        • Greenville Hospital System
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Children's Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 7 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Ventilator-free Days
Time Frame: 120 days
120 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Hospital Stay
Time Frame: 120 days
120 days
Days on Antibiotics
Time Frame: 120 days
120 days
Mortality
Time Frame: 120 days
120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Institutes of Health (NIH)
Medical Predictive Science Corporation

Investigators

  • Principal Investigator: Joseph R Moorman, MD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

March 24, 2006

First Submitted That Met QC Criteria

March 24, 2006

First Posted (ESTIMATE)

March 27, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 27, 2013

Last Update Submitted That Met QC Criteria

May 16, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10845

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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