title: Mortality reduction by heart rate characteristic monitoring in very low birth weight neonates: a randomized trial.
abstract: OBJECTIVE
  To test the hypothesis that heart rate characteristics (HRC) monitoring improves neonatal outcomes.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  HRC monitoring can reduce the mortality rate in very low birth weight infants.
authors.affiliation: Department of Medicine, University of Virginia, Charlottesville, VA 22901, USA. rm3h@virginia.edu
authors.forename: Joseph Randall
authors.initials: JR
authors.lastname: Moorman
authors.forename: Waldemar A
authors.initials: WA
authors.lastname: Carlo
authors.forename: John
authors.initials: J
authors.lastname: Kattwinkel
authors.forename: Robert L
authors.initials: RL
authors.lastname: Schelonka
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Porcelli
authors.forename: Christina T
authors.initials: CT
authors.lastname: Navarrete
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bancalari
authors.forename: Judy L
authors.initials: JL
authors.lastname: Aschner
authors.forename: Marshall
authors.initials: M
authors.lastname: Whit Walker
authors.forename: Jose A
authors.initials: JA
authors.lastname: Perez
authors.forename: Charles
authors.initials: C
authors.lastname: Palmer
authors.forename: George J
authors.initials: GJ
authors.lastname: Stukenborg
authors.forename: Douglas E
authors.initials: DE
authors.lastname: Lake
authors.forename: Thomas
authors.initials: T
authors.lastname: Michael O'Shea
mesh_terms: D005260:Female; D006339:Heart Rate; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000401:mortality* / Q000503:physiopathology*; D019102:Infant, Very Low Birth Weight; D008297:Male; D008991:Monitoring, Physiologic