An interventional study of HeRO heart rate characteristics monitor in Sepsis, sponsored by University of Virginia. Completed at 8 sites in United States. Open to participants aged 1 Day to 32 Weeks. Per ClinicalTrials.gov, last updated 2013-05-27.
Sponsored by University of Virginia · Not applicable, Interventional, and Diagnostic
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.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's enrollment of 3,003 is above the median of 105 across 918 interventional studies indexed under Sepsis.
Browse Sepsis studies →University of Virginia is the lead sponsor of 672 studies on the registry; 138 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
Device: HeRO heart rate characteristics monitor
Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
24 hour continuous HRC monitoring with display
Number of Ventilator-free Days
Time frame: 120 days
Duration of Hospital Stay
Time frame: 120 days
Days on Antibiotics
Time frame: 120 days
Mortality
Time frame: 120 days
| Milestone | Intervention | Control |
|---|---|---|
| Started | 1511 | 1492 |
| Completed | 1500 | 1489 |
| Not completed | 11 | 3 |
| Withdrew: Lost to follow-up | 11 | 3 |
| days | Intervention | Control |
|---|---|---|
| Number of Ventilator-free Days | 95.9 ± 35.1 | 93.6 ± 37.8 |
| days | Intervention | Control |
|---|---|---|
| Duration of Hospital Stay | 59.6 ± 33.7 | 58.7 ± 34.5 |
| days | Intervention | Control |
|---|---|---|
| Days on Antibiotics | 15.7 ± 19.4 | 15.0 ± 19.1 |
| participants | Intervention | Control |
|---|---|---|
| Mortality | 122 | 152 |
Collected over 120 days follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | — | 122/1,500 (8.1%) | 0/1,500 (0%) |
| Control | — | 152/1,489 (10.2%) | 0/1,489 (0%) |
| Event | Intervention | Control |
|---|---|---|
| Mortality [120 days]Investigations | 122/1500 | 152/1489 |
| Age, Categorical(Participants) | Intervention | Control | Total |
|---|---|---|---|
| <=18 years | 1511 | 1492 | 3003 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 0.54 ± 0.054 | 0.54 ± 0.054 | 0.54 ± 0.054 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 791 | 767 | 1558 |
| Male | 720 | 725 | 1445 |
| Region of Enrollment(participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 1511 | 1492 | 3003 |
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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