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Randomized Controlled Trial
. 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

Joseph Randall Moorman  1 , 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, Thomas Michael O'Shea
Affiliations
Randomized Controlled Trial

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

Joseph Randall Moorman et al. J Pediatr. 2011 Dec.

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.

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Figures

Figure 1
Figure 1
CONSORT diagram
Figure 2
Figure 2
Screen display of the monitor as used in the study.
Figure 3
Figure 3
A, Survival of very low birth weight infants as a function of time in the infants whose heart rate characteristics monitoring results were displayed (top) and conventional monitoring-only group (bottom). B, Predictiveness curve of the HRC index as a risk model and classifier for neonatal sepsis. The solid line represents 2M HRC index values normalized by the average risk of 0.62% and plotted from lowest to highest with units of fold-increase in risk. The open circles are the proportion of infants per decile with proven sepsis in the next 24 hours.
Figure 3
Figure 3
A, Survival of very low birth weight infants as a function of time in the infants whose heart rate characteristics monitoring results were displayed (top) and conventional monitoring-only group (bottom). B, Predictiveness curve of the HRC index as a risk model and classifier for neonatal sepsis. The solid line represents 2M HRC index values normalized by the average risk of 0.62% and plotted from lowest to highest with units of fold-increase in risk. The open circles are the proportion of infants per decile with proven sepsis in the next 24 hours.
See this image and copyright information in PMC

Comment in

  • Heart rate characteristic monitoring-HeRO or villain?
    Groves AM, Edwards AD. Groves AM, et al. J Pediatr. 2011 Dec;159(6):885-6. doi: 10.1016/j.jpeds.2011.08.049. Epub 2011 Oct 6. J Pediatr. 2011. PMID: 21982302 No abstract available.
  • Heart rate predicts sepsis.
    Cuestas E, Rizzotti A, Agüero G. Cuestas E, et al. J Pediatr. 2012 Oct;161(4):770; author reply 770. doi: 10.1016/j.jpeds.2012.07.001. Epub 2012 Aug 15. J Pediatr. 2012. PMID: 22901737 No abstract available.

References

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