Impact of Heart Rate Characteristics Monitoring in Neonates
HeRO
1 other identifier
interventional
3,003
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable sepsis
Started Aug 2005
Longer than P75 for not_applicable sepsis
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 24, 2006
CompletedFirst Posted
Study publicly available on registry
March 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
May 17, 2013
CompletedMay 27, 2013
May 1, 2013
5.5 years
March 24, 2006
April 3, 2012
May 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Ventilator-free Days
120 days
Secondary Outcomes (3)
Duration of Hospital Stay
120 days
Days on Antibiotics
120 days
Mortality
120 days
Study Arms (2)
1
EXPERIMENTALVery low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
2
NO INTERVENTIONVery low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Virginialead
- National Institutes of Health (NIH)collaborator
- Medical Predictive Science Corporationcollaborator
Study Sites (8)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Miami
Miami, Florida, 33101, United States
Winnie Plamer Hospital for Women and Babies
Orlando, Florida, 32806, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Greenville Hospital System
Greenville, South Carolina, 29617, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Related Publications (5)
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.
PMID: 34798080DERIVEDKing 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.
PMID: 34247026DERIVEDSwanson 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.
PMID: 29703576DERIVEDSullivan 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.
PMID: 24412138DERIVEDMoorman 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.
PMID: 21864846DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joseph R. Moorman, MD
- Organization
- University of Virginia
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph R Moorman, MD
University of Virginia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2006
First Posted
March 27, 2006
Study Start
August 1, 2005
Primary Completion
February 1, 2011
Study Completion
May 1, 2011
Last Updated
May 27, 2013
Results First Posted
May 17, 2013
Record last verified: 2013-05