Mortality reduction by heart rate characteristic monitoring in very low birth weight neonates: a randomized trial

J Pediatr. 2011 Dec;159(6):900-6.e1. doi: 10.1016/j.jpeds.2011.06.044. Epub 2011 Aug 24.


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.

Trial registration: NCT00307333.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Female
  • Heart Rate*
  • Humans
  • Infant, Newborn
  • Infant, Newborn, Diseases / mortality*
  • Infant, Newborn, Diseases / physiopathology*
  • Infant, Very Low Birth Weight*
  • Male
  • Monitoring, Physiologic*

Associated data