Original ArticleAutomated Adjustment of Inspired Oxygen in Preterm Infants with Frequent Fluctuations in Oxygenation: A Pilot Clinical Trial
Section snippets
Methods
The study was conducted at the “Project: New Born” Neonatal Intensive Care Unit of the University of Miami/Jackson Memorial Medical Center. The study was approved by the University of Miami Human Subjects Research Office and the Western Institutional Review Board (Olympia, Washington). Mechanically ventilated preterm infants receiving supplemental O2 were enrolled when they had ≥8 spontaneous episodes of hypoxemia (SpO2 < 85%) in 4 hours. Infants with major congenital anomalies, acute
Results
Sixteen ventilated preterm infants receiving supplemental O2 and with frequent episodes of hypoxemia were enrolled from December 2006 to July 2007. They were born at 24.9 ± 1.4 weeks of gestation and weighed 678 ± 144 g. At the time of the study, they were 33 ± 15 days old, weighed 973 ± 340 g, and had been on a ventilator for 28 ± 17 days. Infants were on synchronized intermittent mandatory ventilation (SIMV) at 21 ± 9 cycles/min, peak inspiratory pressure of 18 ± 2 cmH2O, and positive
Discussion
We show that, compared with manual adjustments by a routine caregiver, automated FiO2 adjustments increased time within the intended SpO2 range in a group of preterm infants with frequent hypoxemia episodes. This was predominantly caused by a reduction in time with SpO2 higher than the intended range that was accompanied by a reduction in hyperoxemia. It could be argued that the increase in time within the intended range is not clinically relevant. However, this was achieved in a very
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Supported by Viasys Healthcare, The University of Miami “Project: New Born,” and The Bank of America Charitable Foundation. Presented in part at the 2007 meeting of the Society for Pediatric Research. The authors have a patent on the algorithm used to automatically adjust the inspired oxygen. The University of Miami, the assignee for this patent, has a license agreement with Viasys Healthcare. Viasys Healthcare and Masimo Corporation have supported post-graduate educational activities at the University of Miami.