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Impact of Heart Rate Characteristics Monitoring in Neonates

NCT00307333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3003

Last updated 2013-05-27

Study results available
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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.

Conditions

Interventions

DEVICE

HeRO heart rate characteristics monitor

24 hour continuous HRC monitoring with display

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Medical Predictive Science Corporation

    collaborator UNKNOWN

  • University of Virginia

    lead OTHER

Principal Investigators

  • Joseph R Moorman, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2011-02-28
Completion
2011-05-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00307333 on ClinicalTrials.gov