Impact of Heart Rate Characteristics Monitoring in Neonates

Completed · Not applicable

Conditions studied: Sepsis

In brief

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.

Key facts

Study ID

NCT00307333

Run by

University of Virginia

People needed

3003

Starts

2005-08-01

Expected to finish

2011-05-01

Last updated by the study team

2013-05-27

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants admitted to NICU
• Birth weight < 1500 grams
• Gestational age < or = 32 weeks
• Informed consent obtained from parent

You may not qualify if…

• Evidence of sustained cardiac arrhythmia
• Use of an electronic pacemaker

Where it is running

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

Full record on ClinicalTrials.gov

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