Mortality Reduction by Heart Rate Characteristic Monitoring in Very Low Birth Weight Neonates: A Randomized Trial
2011
Moorman, Joseph Randall | Carlo, Waldemar A. | Kattwinkel, John | Schelonka, Robert L. | Porcelli, Peter J. | Navarrete, Christina T. | Bancalari, Eduardo | Aschner, Judy L. | Whit Walker, Marshall | Pérez, José A. | Palmer, Charles | Stukenborg, George J. | Lake, Douglas E. | Michael O’Shea, Thomas
OBJECTIVE: To test the hypothesis that heart rate characteristics (HRC) monitoring improves neonatal outcomes. STUDY DESIGN: We conducted a two-group, parallel, individually randomized controlled clinical trial of 3003 very low birth weight infants in 9 neonatal intensive care units. In one group, HRC monitoring was displayed; in the other, it was masked. The primary outcome was number of days alive and ventilator-free in the 120 days after randomization. Secondary outcomes were mortality, number of ventilator days, neonatal intensive care unit stay, and antibiotic use. RESULTS: The mortality rate was reduced in infants whose HRC monitoring was displayed, from 10.2% to 8.1% (hazard ratio, 0.78; 95% CI, 0.61-0.99; P = .04; number needed to monitor = 48), and there was a trend toward increased days alive and ventilator-free (95.9 of 120 days compared with 93.6 in control subjects, P = .08). The mortality benefit was concentrated in infants with a birth weight <1000 g (hazard ratio, 0.74; 95% CI, 0.57-0.95; P = .02; number needed to monitor = 23). There were no significant differences in the other outcomes. CONCLUSION: HRC monitoring can reduce the mortality rate in very low birth weight infants.
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