Impact of Heart Rate Characteristics Monitoring in Neonates (HeRO)

This study has been completed.

Sponsor:

Collaborators:

National Institutes of Health (NIH)

Medical Predictive Science Corporation

Information provided by (Responsible Party):

University of Virginia

ClinicalTrials.gov Identifier:

NCT00307333

First received: March 24, 2006

Last updated: May 16, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 24, 2006

Last Updated Date

May 16, 2013

Start Date ^ICMJE

August 2005

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Ventilator-free Days [ Time Frame: 120 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Number of ventilator-free days

Change History

Complete list of historical versions of study NCT00307333 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of Hospital Stay [ Time Frame: 120 days ] [ Designated as safety issue: No ]
Days on Antibiotics [ Time Frame: 120 days ] [ Designated as safety issue: No ]
Mortality [ Time Frame: 120 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Duration of hospital stay
Days on antibiotics

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Impact of Heart Rate Characteristics Monitoring in Neonates

Official Title ^ICMJE

Impact of Heart Rate Characteristics Monitoring in Neonates

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Sepsis

Intervention ^ICMJE

Device: HeRO heart rate characteristics monitor

24 hour continuous HRC monitoring with display

Study Arm (s)

Experimental: 1
Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.

Intervention: Device: HeRO heart rate characteristics monitor
No Intervention: 2
Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.

Publications *

Moorman JR, Carlo WA, Kattwinkel J, Schelonka RL, Porcelli PJ, Navarrete CT, Bancalari E, Aschner JL, Whit Walker M, Perez JA, Palmer C, Stukenborg GJ, Lake DE, Michael O'Shea T. Mortality reduction by heart rate characteristic monitoring in very low birth weight neonates: a randomized trial. J Pediatr. 2011 Dec;159(6):900-6.e1. Epub 2011 Aug 24.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3003

Completion Date

May 2011

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 32 Weeks

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00307333

Other Study ID Numbers ^ICMJE

10845

Has Data Monitoring Committee

Yes

Responsible Party

University of Virginia

Study Sponsor ^ICMJE

University of Virginia

Collaborators ^ICMJE

National Institutes of Health (NIH)
Medical Predictive Science Corporation

Investigators ^ICMJE

Principal Investigator:

Joseph R Moorman, MD

University of Virginia

Information Provided By

University of Virginia

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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