Impact of Heart Rate Characteristics Monitoring in Neonates

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Heart Rate Characteristics Monitoring in Neonates

Conditions
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Sepsis

Intervention / Treatment
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* Device: HeRO heart rate characteristics monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 24 hour continuous HRC monitoring with display<br>|
| No Intervention: 2<br>Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Ventilator-free Days |  | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Hospital Stay |  | 120 days | 
| Days on Antibiotics |  | 120 days | 
| Mortality |  | 120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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very low birth weight infants, heart rate characteristics