Clinical Evaluation of an Automatic Oxygen Control System for Premature Infants Receiving High-Flow Nasal Cannula for Respiratory Support: A Pilot Study.

A pilot clinical study was conducted that compared the peripheral oxygen saturation (SpO2) targeting performance of an automatic oxygen control system with manual oxygen control, which is the standard of care for preterm and low birth weight infants on high-flow nasal cannula (HFNC). The new oxygen control device studied was used to automatically adjust the fraction of inspired oxygen (FiO2) according to a desired SpO2 target setpoint and measured feedback signals including the SpO2 and other signals. A crossover study was designed with several endpoints including the comparison of the percentage of time that the SpO2 was within the target range with the automatic oxygen control device versus manual oxygen control. Other metrics were also compared to assess the performance of the system including the number of bradycardia events. The pilot study included six patients that fit the inclusion criteria. The results showed that there were improvements in all of the measured outcomes considered including statistically significant improvements in the number of bradycardia events during the period when the automatic oxygen control device was used.

Comparison of Automated and Manual Peripheral Oxygen Saturation Control Applied to One Human Subject at a High Target Range.

Newborn infants, mainly those born prematurely, often require respiratory support with a varying concentration of the fraction of inspired oxygen (FiO$_{\mathbf {2}}$) to keep the peripheral oxygen saturation (SpO$_{\mathbf {2}}$) within the desired range to prevent adverse health effects due to both high and low SpO$_{\mathbf {2}}$. Manual adjustment, by nurses, is the common practice. However, the efficacy of the manual control is questionable. A novel automatic controller is evaluated clinically with application to one human subject at a high target SpO$_{\mathbf {2}}$. The automatic controller demonstrated the ability to improve oxygen saturation control over the everyday routine manual control by increasing the proportion of time where SpO$_{\mathbf {2}}\textbf{v}$alues were within the desired range.

Differential expression of cancer-associated proteins in breastmilk.

Breast cancer that develops during or shortly after pregnancy is frequently more aggressive than cancer diagnosed at other times in a woman's life. To better understand the patterns of cancer-related protein expression in the breasts of lactating women, we determined the differences in total and individual protein expression in milk based on (a) three time points during lactation (early, mid, and late), (b) length of lactation, and (c) parity. Breastmilk was collected from 72 healthy lactating women within 10 days of starting lactation (transitional [T]), 2 months after lactation started, and during breast weaning (W). Sixteen proteins whose expression is altered in breast cancer (11 kallikreins [KLKs], basic fibroblast growth factor [bFGF], YKL-40, neutrophil gelatinase-associated lipocalin, and transforming growth factor [TGF] ß1 and ß2) were evaluated. The concentration of total milk protein decreased over time (p<0.01 at 2 months and W compared with T). After we controlled for total protein, KLK6 and TGFß2 significantly increased, and bFGF decreased from T to W. Neither length of nursing nor parity significantly influenced individual protein expression at the W time point. On the other hand, length of nursing did influence the difference in KLK6, -7, and -8 expression between the W and T time points. Total milk protein concentration is lower in the mid and late phases of nursing. Biomarker differences between T and W milk samples in KLK6, TGFß2, and bFGF are consistent with a protective effect of nursing.