N/A Completed N=3,003 Randomized Diagnostic

Impact of Heart Rate Characteristics Monitoring in Neonates

Sepsis

Source: ClinicalTrials.gov NCT00307333 ↗

Enrolled (actual)

3,003

Serious AEs

9.2%

Results posted

May 2013

Primary outcomePrimary: Number of Ventilator-free Days — 95.9; 93.6 days — p=0.08

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.