TY - JOUR
T1 - Mortality reduction by heart rate characteristic monitoring in very low birth weight neonates
T2 - A randomized trial
AU - Moorman, Joseph Randall
AU - Carlo, Waldemar A.
AU - Kattwinkel, John
AU - Schelonka, Robert L.
AU - Porcelli, Peter J.
AU - Navarrete, Christina T.
AU - Bancalari, Eduardo
AU - Aschner, Judy L.
AU - Whit Walker, Marshall
AU - Perez, Jose A.
AU - Palmer, Charles
AU - Stukenborg, George J.
AU - Lake, Douglas E.
AU - Michael O'Shea, Thomas
N1 - Funding Information:
Supported by National Institutes of Health (grant R01-HD48562 to J.M.) and by Medical Predictive Science Corporation , Charlottesville, VA, which provided study hardware and software for heart rate characteristics monitoring and for study data collection and management. Neither of these funding sources had any role in the design of the study, in the analysis and interpretation of the data, in the decision to submit the manuscript, or in the preparation, review, or approval of it. J.M. and D.L. have consulting agreements and equity shares in Medical Predictive Science Corporation, Charlottesville, VA. The other authors declare no conflicts of interest.
PY - 2011/12
Y1 - 2011/12
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jpeds.2011.06.044
DO - 10.1016/j.jpeds.2011.06.044
M3 - Article
C2 - 21864846
AN - SCOPUS:84860389704
VL - 159
SP - 900-906.e1
JO - Journal of Pediatrics
JF - Journal of Pediatrics
SN - 0022-3476
IS - 6
ER -