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

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.

Low-dose nitric oxide therapy for persistent pulmonary hypertension: 1-year follow-up.

BACKGROUND: Although inhaled nitric oxide has been shown to reduce the use of extracorporeal membrane oxygenation, there is limited data on its effect on long-term outcomes. OBJECTIVE: The purpose of our study is to report on the 1 year outcome of neonates treated with inhaled nitric oxide compared to a group of neonates who did not receive nitric oxide. METHODS: We have previously reported on the in-hospital outcomes of 248 neonates who were >34 weeks' gestational age and were randomized to receive low-dose inhaled nitric oxide or placebo. Extracorporeal membrane oxygenation was used in 78 (64%) neonates in the control group and in 48 (38%) neonates in the inhaled nitric oxide group (p=0.001). We now report on the outcome of neonates followed to 1 year of age. RESULTS: Of the 248 neonates twenty-four (10%) died before 1 year of age. There was no difference in mortality between the two groups (11% in the control group and 9% in the inhaled nitric oxide group). Of the 224 surviving infants, we were able to contact the parents or guardians of 201 (90%) children. There were no intergroup differences in the numbers of patients reported as requiring medications for pulmonary disease (14% in the control group and 14% in the inhaled nitric oxide group) or the need for supplemental oxygen (1% in the control group and 0% in the inhaled nitric oxide group). The number of neonates reported to have an abnormal neurological examination or developmental delay was also similar in both groups (14% in the control group and 19% in the inhaled nitric oxide group). CONCLUSIONS: The use of low-dose inhaled nitric oxide reduces the use of extracorporeal membrane oxygenation without increasing the incidence of adverse outcomes to 1 year of age.