Impact of Heart Rate Characteristics Monitoring in Neonates
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- University of Virginia
- Enrollment
- 3003
- Locations
- 8
- Primary Endpoint
- Number of Ventilator-free Days
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Ventilator-free Days
Time Frame: 120 days
Secondary Outcomes
- Duration of Hospital Stay(120 days)
- Mortality(120 days)
- Days on Antibiotics(120 days)