Impact of Heart Rate Characteristics Monitoring in Neonates (HeRO)

University of Virginia

Status: Completed

Conditions: Sepsis

Treatments: Device: HeRO heart rate characteristics monitor

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00307333

10845

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,003 patients

Sex: All

Ages: 1 day to 32 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,003 participants in 2 patient groups

1

Experimental group

Description:

Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.

Treatment:

Device: HeRO heart rate characteristics monitor

2

No Intervention group

Description:

Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.