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

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

Author information

1
Department of Medicine, University of Virginia, Charlottesville, VA 22901, USA. rm3h@virginia.edu

Abstract

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:

ClinicalTrials.gov NCT00307333.

PMID:
21864846
PMCID:
PMC3215822
DOI:
10.1016/j.jpeds.2011.06.044
[Indexed for MEDLINE]
Free PMC Article

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