N/A
N=3,003
Impact of Heart Rate Characteristics Monitoring in Neonates
Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT00307333 ↗Enrolled (actual)
3,003
Serious AEs
9.2%
Results posted
May 2013
Primary outcome: Primary: Number of Ventilator-free Days — 95.9; 93.6 days — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HeRO heart rate characteristics monitor (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Ventilator-free Days |
95.9; 93.6 | 0.08 |
| SECONDARY Duration of Hospital Stay |
59.6; 58.7 | 0.47 |
| SECONDARY Days on Antibiotics |
15.7; 15.0 | 0.31 |
| SECONDARY Mortality |
122; 152 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00307333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.