Sepsis
Conditions
Keywords
very low birth weight infants, heart rate characteristics
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.
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.
Interventions
DEVICEHeRO heart rate characteristics monitor
24 hour continuous HRC monitoring with display
Sponsors
National Institutes of Health (NIH)
Medical Predictive Science Corporation
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* Infants admitted to NICU * Birth weight \< 1500 grams * Gestational age \< or = 32 weeks * Informed consent obtained from parent
Exclusion criteria
* Evidence of sustained cardiac arrhythmia * Use of an electronic pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Ventilator-free Days | 120 days |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Hospital Stay | 120 days |
| Days on Antibiotics | 120 days |
| Mortality | 120 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan. | 1,511 |
| Control Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment. | 1,492 |
| Total | 3,003 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 3 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1492 Participants | 1511 Participants | 3003 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 0.54 years STANDARD_DEVIATION 0.054 | 0.54 years STANDARD_DEVIATION 0.054 | 0.54 years STANDARD_DEVIATION 0.054 |
| Region of Enrollment United States | 1492 participants | 1511 participants | 3003 participants |
| Sex: Female, Male Female | 767 Participants | 791 Participants | 1558 Participants |
| Sex: Female, Male Male | 725 Participants | 720 Participants | 1445 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,500 | 0 / 1,489 |
| serious Total, serious adverse events | 122 / 1,500 | 152 / 1,489 |
Outcome results
Primary
Number of Ventilator-free Days
Time frame: 120 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Number of Ventilator-free Days | 95.9 days | Standard Deviation 35.1 |
| Control | Number of Ventilator-free Days | 93.6 days | Standard Deviation 37.8 |
p-value: 0.08t-test, 2 sided
Secondary
Days on Antibiotics
Time frame: 120 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Days on Antibiotics | 15.7 days | Standard Deviation 19.4 |
| Control | Days on Antibiotics | 15.0 days | Standard Deviation 19.1 |
p-value: 0.31t-test, 2 sided
Secondary
Duration of Hospital Stay
Time frame: 120 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Duration of Hospital Stay | 59.6 days | Standard Deviation 33.7 |
| Control | Duration of Hospital Stay | 58.7 days | Standard Deviation 34.5 |
p-value: 0.47t-test, 2 sided
Secondary
Mortality
Time frame: 120 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Mortality | 122 participants |
| Control | Mortality | 152 participants |
95% CI: [0.61, 0.99]