CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,003 enrolled
Drug / intervention
HeRO heart rate characteristics monitordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00307333
NCT00307333N/ACompleted
CompareCT.gov

Impact of Heart Rate Characteristics Monitoring in Neonates

University of Virginia·interventional·Posted Mar 27, 2006·Updated May 27, 2013

In Brief

A clinical study evaluating HeRO heart rate characteristics monitor for Sepsis. Completed, enrolled 3,003 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), Medical Predictive Science Corporation

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 27, 2006
Enrollment StartAug 1, 2005
Primary CompletionFeb 1, 2011
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 20.3 years ago

Interventions

HeRO heart rate characteristics monitordevice

24 hour continuous HRC monitoring with display