Original ArticleMortality Reduction by Heart Rate Characteristic Monitoring in Very Low Birth Weight Neonates: A Randomized Trial
Section snippets
Methods
Very low birth weight (<1500 g birth weight) infants at 9 hospitals were randomized to display or not to display the HRC monitor results. This was a parallel group study with one-to-one randomization. Initially, all inborn and outborn babies with birth weights <1500 g were eligible. After enrolling 257 infants, we further restricted inclusion criteria for outborn infants to include only very low birth weight infants who had been transferred to a study center at <33 weeks post-menstrual age.
Results
We screened 5995 infants for eligibility (Figure 1). A total of 3003 infants were randomized from April 2004 through May 2010. A total of 2989 infants were included in the analysis. Before unblinding and analysis, we excluded 14 randomized infants because of birth weight ≥1500 g (4 in the study group, one in the control group), error in randomization (3, all in the study group), consent withdrawn (two in the study group, one in the control group), or sustained cardiac arrhythmia (two in the
Discussion
In this large, simple randomized trial,18 we tested the hypothesis that HRC monitoring, which detects the abnormal reduced variability and transient decelerations that often precede late-onset neonatal sepsis, can improve outcomes in very low birth weight infants. The 2.3-day increase of the composite primary outcome measure of days alive and not on a ventilator in the infants whose HRC monitoring results were displayed was not statistically significant (P = .08). We found, however, a
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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.
Trial is registered at ClinicalTrials.gov (NCT00307333).
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Present address: University of Oregon Health Sciences Center, Portland, Oregon.