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Completed

NCT Number: NCT00307333

Impact of Heart Rate Characteristics Monitoring in Neonates

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

1 day–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HeRO heart rate characteristics monitor

Device

24 hour continuous HRC monitoring with display

Primary outcomes

  1. Number of Ventilator-free Days

    Time frame: 120 days

Secondary outcomes

  1. Duration of Hospital Stay

    Time frame: 120 days

  2. Days on Antibiotics

    Time frame: 120 days

  3. Mortality

    Time frame: 120 days

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Medical Predictive Science Corporation
  • National Institutes of Health (NIH)

Registry information

Acronym: HeRO

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Mar 27, 2006
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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