Direct-to-participant recruitment of mothers and infants: A strategic approach during challenging pandemic times.

Under traditional circumstances, most clinical trials rely on in-person operations to identify, recruit, and enroll study participants and to complete study-related visits. During unusual circumstances, such as the COVID-19 pandemic, the typical clinical trial model is challenged and forced to explore alternative approaches to implementing study recruitment, participant enrollment, and data collection strategies. One such alternative is a direct-to-participant approach which leverages electronic resources and relevant technological devices (e.g., smart phones) available to researchers and patients. This approach functions under the assumption that a participant has access to a device that connects to the internet such as a smart phone, tablet, or computer. Researchers are then able to transition a typical paper-based, in-person model to an electronic-based, siteless, remote study. This article describes the challenges clinicians and researchers faced when implementing a direct-to-participant study approach during the COVID-19 pandemic. The lessons learned during this study of infant populations could help increase efficiency of future trials, specifically, by lessening the burden on participants and clinicians as well as streamlining the process for enrollment and data collection. While direct-to-adult participant recruitment is not a novel approach, our findings suggest that studies attempting to recruit the infant population may benefit from such a direct-to-participant approach.

The measurement of accurate fetal hemoglobin and related oxygen saturation by the hemoximeter.

BACKGROUND: The purposes of this study were to examine the accuracy of fetal hemoglobin (HbF) as quickly measured by the hemoximeter, verified by the high-performance liquid chromatography method, and to examine related oxygen saturation (SO(2)) measurements in neonates. METHODS: Thirty-nine neonates with gestational ages ranging from 25 to 38 weeks were investigated (n=280 blood samples). Twenty younger premature neonates had blood transfusions (n=188 blood samples, 72 before and 116 after transfusions), and 19 older neonates did not. RESULTS: The bias of the hemoximeter was 23% (+/-9.1) against the HPLC; 25% (+/-7.9) before, and 19% (+/-8.6) after blood transfusions (all P<0.001), for HbF measurements. A regression line (HbFt by the HPLC=8.46+0.7 x HbF by the hemoximeter) has been provided for the prediction. Oxyhemoglobin dissociation curves with the status of (before and after) blood transfusions were presented. In relation to oxygen tension values of 50-75 mm Hg, in addition to the right-shifted oxyhemoglobin dissociation curves, pulse oximeter ranged from 95 to 98% before the transfusions, but decreased to 94 to 96% after the blood transfusions. CONCLUSIONS: Accurate HbF and related oxygen saturation measurements need to be determined, especially for premature neonates, to minimize the risk of oxygen toxicity.