Impact of Heart Rate Characteristics Monitoring in Neonates

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Device: HeRO heart rate characteristics monitor

• Registration Number: NCT00307333
• Lead Sponsor: University of Virginia

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.

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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-03-24
• Study First Submitted QC: 2006-03-24
• Study First Posted: 2006-03-27
• Primary Completion: 2011-02
• Study Completion: 2011-05
• Results First Submitted: 2012-04-03
• Results First Submitted QC: 2013-04-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-16
• Results First Posted: 2013-05-17
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3003

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	HeRO heart rate characteristics monitor	Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.

Primary Outcome Measures

Name	Time	Method
Number of Ventilator-free Days	120 days

Secondary Outcome Measures

Name	Time	Method
Duration of Hospital Stay	120 days
Mortality	120 days
Days on Antibiotics	120 days

Trial Locations

Locations (8)

University of Miami; 🇺🇸 Miami, Florida, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Winnie Plamer Hospital for Women and Babies; 🇺🇸 Orlando, Florida, United States

Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Vanderbilt Children's Hospital; 🇺🇸 Nashville, Tennessee, United States

Greenville Hospital System; 🇺🇸 Greenville, South Carolina, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States