SepsisHeRONCT00307333
Impact of Heart Rate Characteristics Monitoring in Neonates
A study testing HeRO heart rate characteristics monitor in people with Sepsis, run by University of Virginia at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 32 weeks
- Conditions the study is for
- Sepsis
- What is being tested?
- HeRO heart rate characteristics monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,003 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2005to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants admitted to NICU
- Birth weight < 1500 grams
- Gestational age < or = 32 weeks
- Informed consent obtained from parent
Who cannot join
- Evidence of sustained cardiac arrhythmia
- Use of an electronic pacemaker
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Virginia
Charlottesville, Virginia, 22908
Greenville Hospital System
Greenville, South Carolina, 29617
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Miami
Miami, Florida, 33101
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
Winnie Plamer Hospital for Women and Babies
Orlando, Florida, 32806
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- HeRO heart rate characteristics monitor
- Keywords
- very low birth weight infants, heart rate characteristics
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeRO heart rate characteristics monitorDevice
24 hour continuous HRC monitoring with display
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan. Receives: Device: HeRO heart rate characteristics monitor |
| 2 | No intervention | Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Ventilator-free Days
Measured: 120 days
Secondary outcomes (3)
Duration of Hospital Stay
Measured: 120 days
Days on Antibiotics
Measured: 120 days
Mortality
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2006 (estimated)
- Study startAug 2005
- Primary completionFeb 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Medical Predictive Science Corporation
- Responsible party
- Sponsor
- Investigators
- Joseph R Moorman, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307333
- Sponsor's protocol ID
- 10845
- Acronym
- HeRO
- Status last verified
- May 2013
- First submitted
- 24 Mar 2006
- Last updated
- 27 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34798080King 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.
PubMed 34247026Swanson 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.
PubMed 29703576Sullivan 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.
PubMed 24412138Moorman 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.
PubMed 21864846
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Heart Rate Characteristics Monitoring in Neonates
- ClinicalTrials.gov ID
- NCT00307333
- Acronym / sponsor ID
- HeRO / 10845
- Conditions
- Sepsis
- Keywords
- very low birth weight infants, heart rate characteristics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,003 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Medical Predictive Science Corporation
- Study start
- Aug 2005
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Mar 2006 (estimated)
- Results
- Posted 17 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: HeRO heart rate characteristics monitorVery low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan. |
| 2 | No intervention | –Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment. |
Who may qualify
- Ages
- 1 day to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants admitted to NICU
- Birth weight < 1500 grams
- Gestational age < or = 32 weeks
- Informed consent obtained from parent
Key exclusion criteria (2 listed)
- Evidence of sustained cardiac arrhythmia
- Use of an electronic pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeRO heart rate characteristics monitor24 hour continuous HRC monitoring with display | Device | 1 |
Primary outcome
Number of Ventilator-free Days
Time frame: 120 days
3 secondary outcomes
Duration of Hospital Stay
Time frame: 120 days
Days on Antibiotics
Time frame: 120 days
Mortality
Time frame: 120 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34798080King 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.
- Derived from this study: PubMed 34247026King 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.
- Derived from this study: PubMed 29703576Swanson 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.
- Derived from this study: PubMed 24412138Sullivan 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.
- Derived from this study: PubMed 21864846Moorman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph R Moorman, MD principal investigator
University of Virginia
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeRO heart rate characteristics monitor in people with Sepsis, run by University of Virginia at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Ventilator-free Days (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00307333, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2013.