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The Journal of pediatrics · Dec 2011
Randomized Controlled Trial Multicenter StudyMortality reduction by heart rate characteristic monitoring in very low birth weight neonates: a randomized trial.
- Joseph Randall Moorman, Waldemar A Carlo, John Kattwinkel, Robert L Schelonka, Peter J Porcelli, Christina T Navarrete, Eduardo Bancalari, Judy L Aschner, Marshall Whit Walker, Jose A Perez, Charles Palmer, George J Stukenborg, Douglas E Lake, and Thomas Michael O'Shea.
- Department of Medicine, University of Virginia, Charlottesville, VA 22901, USA. rm3h@virginia.edu
- J. Pediatr. 2011 Dec 1;159(6):900-6.e1.
ObjectiveTo test the hypothesis that heart rate characteristics (HRC) monitoring improves neonatal outcomes.Study DesignWe 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.ResultsThe 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.ConclusionHRC monitoring can reduce the mortality rate in very low birth weight infants.Copyright © 2011 Mosby, Inc. All rights reserved.
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