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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Medical Predictive Science Corporation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Very 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeRO heart rate characteristics monitor | Device | 24 hour continuous HRC monitoring with display |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Ventilator-free Days | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospital Stay | 120 days | |
| Days on Antibiotics | 120 days | |
| Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph R Moorman, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34798080 | Derived | 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. | |
| 34247026 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan. |
| FG001 | Control | Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan. |
| BG001 | Control | Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Ventilator-free Days | Posted | Mean | Standard Deviation | days | 120 days |
|
|
120 days follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mortality [120 days] | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph R. Moorman, MD | University of Virginia | 434-982-3367 | rm3h@virginia.edu |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| 120 days |
| 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 |
| 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. |
| 29703576 | Derived | 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. |
| 24412138 | Derived | 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. |
| 21864846 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | correct as reported | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Duration of Hospital Stay | Posted | Mean | Standard Deviation | days | 120 days |
|
|
|
|
| Secondary | Days on Antibiotics | Posted | Mean | Standard Deviation | days | 120 days |
|
|
|
|
| Secondary | Mortality | Posted | Number | participants | 120 days |
|
|
|
|
| 122 |
| 1,500 |
| 0 |
| 1,500 |
| EG001 | Control | Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment. | 152 | 1,489 | 0 | 1,489 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |