Impact of Heart Rate Characteristics Monitoring in Neonates
NCT ID: NCT00307333
Last Updated: 2013-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
3003 participants
INTERVENTIONAL
2005-08-31
2011-05-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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1
Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
HeRO heart rate characteristics monitor
24 hour continuous HRC monitoring with display
2
Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
No interventions assigned to this group
Interventions
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HeRO heart rate characteristics monitor
24 hour continuous HRC monitoring with display
Eligibility Criteria
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Inclusion Criteria
* Birth weight \< 1500 grams
* Gestational age \< or = 32 weeks
* Informed consent obtained from parent
Exclusion Criteria
* Use of an electronic pacemaker
1 Day
32 Weeks
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Medical Predictive Science Corporation
UNKNOWN
University of Virginia
OTHER
Responsible Party
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Principal Investigators
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Joseph R Moorman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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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
Countries
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References
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King WE, Carlo WA, O'Shea TM, Schelonka RL; HRC neurodevelopmental follow-up investigators. Multivariable Predictive Models of Death or Neurodevelopmental Impairment Among Extremely Low Birth Weight Infants Using Heart Rate Characteristics. J Pediatr. 2022 Mar;242:137-144.e4. doi: 10.1016/j.jpeds.2021.11.026. Epub 2021 Nov 17.
King WE, Carlo WA, O'Shea TM, Schelonka RL; HRC neurodevelopmental follow-up investigators. Heart rate characteristics monitoring and reduction in mortality or neurodevelopmental impairment in extremely low birthweight infants with sepsis. Early Hum Dev. 2021 Aug;159:105419. doi: 10.1016/j.earlhumdev.2021.105419. Epub 2021 Jul 4.
Swanson JR, King WE, Sinkin RA, Lake DE, Carlo WA, Schelonka RL, Porcelli PJ, Navarrete CT, Bancalari E, Aschner JL, Perez JA, O'Shea TM, Walker MW. Neonatal Intensive Care Unit Length of Stay Reduction by Heart Rate Characteristics Monitoring. J Pediatr. 2018 Jul;198:162-167. doi: 10.1016/j.jpeds.2018.02.045. Epub 2018 Apr 24.
Sullivan BA, Grice SM, Lake DE, Moorman JR, Fairchild KD. Infection and other clinical correlates of abnormal heart rate characteristics in preterm infants. J Pediatr. 2014 Apr;164(4):775-80. doi: 10.1016/j.jpeds.2013.11.038. Epub 2014 Jan 10.
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. doi: 10.1016/j.jpeds.2011.06.044. Epub 2011 Aug 24.
Other Identifiers
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10845
Identifier Type: -
Identifier Source: org_study_id
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