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Distortion product otoacoustic emissions (DPOAE) offer an alternative to transiently evoked otoacoustic emissions (TEOAE) as an audiological test. The former can be used as a screening technique, and may also provide frequency-specific information about the functional state of the cochlea. We recorded DPOAE in a group of healthy newborns to establish the characteristics of a DPOAE "audiogram" (DP-gram) in this population. The DP-gram can be obtained with characteristics quite similar to those observed in adults, with two sharp peaks of maximum amplitude at F2 frequencies of 2 kHz and 5-6 kHz, and a decline in DPOAE amplitude in midfrequencies. The results confirm the limitations of DPOAE recording for testing parts of the basilar membrane where lower frequencies are coded.

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Introduction Vitamin D is a preprohormone known to play a key role in phosphocalcic metabolism; its main source comes from the synthesis at the skin level by ultraviolet (UV) radiation. Objective The purpose of this study was to determine the levels of vitamin D in an Ecuadorian population. Materials and Methods Retrospective study of Ecuadorian subjects from the city of Guayaquil, who had an initial study of 25 (OH)-D serum, as the indicator of Vitamin D status, in the period of 2015-2016. Results A total of 269 Ecuadorian subjects were analyzed, with a mean age of 54.73 ± 16.58; 85% (229) were females and 15% (41) males; mean vitamin D was 27.29 ± 10.12 ng/dl [6.41–88.74]; 70% of the population showed levels below 30 ng/dL of vitamin D, whereas only 30% (81) had normal values. 69% (185) had levels between 29 and 10 ng/dl and 1% (3) levels below 10 ng/dl. High levels of vitamin D were evidenced in the summer months in relation to the winter months. Conclusion It is evident that, despite the location of Ecuador and the intensity of UV rays it receives throughout the year, Ecuadorian subjects have insufficient levels of vitamin D.

Background Despite improvement in the standard of care (SOC) for hospitalized COVID-19 patients, rates of morbidity and mortality remain high. There continues to be a need for easily available and cost-effective treatments. Colchicine and rosuvastatin are both safe and well-studied medications with anti-inflammatory and other pleiotropic effects that may provide additional benefits to hospitalized COVID-19 patients. Methods and results The Colchicine/Statin for the Prevention of COVID-19 Complications (COLSTAT) Trial is a pragmatic, open-label, multicenter, randomized trial comparing the combination of colchicine and rosuvastatin in addition to SOC to SOC alone in hospitalized COVID-19 patients. Four centers in the Yale New Haven Health network will enroll a total of 466 patients with 1:1 randomization. The trial will utilize the electronic health record (Epic® Systems, Verona, Wisconsin, USA) at all stages including screening, randomization, intervention, event ascertainment, and follow-up. The primary endpoint is the 30-day composite of progression to severe COVID-19 disease as defined by the World Health Organization ordinal scale of clinical improvement and arterial/venous thromboembolic events. The secondary powered endpoint is the 30-day composite of death, respiratory failure requiring intubation, and myocardial injury. Conclusions The COLSTAT trial will provide evidence on the efficacy of repurposing colchicine and rosuvastatin for the treatment of hospitalized COVID-19 patients. Moreover, it is designed to be a pragmatic trial that will demonstrate the power of using electronic health records to improve efficiency and enrollment in clinical trials in an adapting landscape. Clinical Trial Registration: NCT04472611 ( https://clinicaltrials.gov/ct2/show/NCT04472611 ).

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ObjectiveTo evaluate the effect of colchicine and high-intensity rosuvastatin in addition to standard of care on the progression of COVID-19 disease in hospitalised patients.DesignA pragmatic, open-label, multicentre, randomised controlled trial conducted from October 2020 to September 2021. Follow-up was conducted at 30 and 60 days. The electronic medical record was used at all stages of the trial including screening, enrolment, randomisation, event ascertainment and follow-up.SettingFour centres in the Yale New Haven Health System.ParticipantsNon-critically ill hospitalised patients with COVID-19.InterventionsPatients were randomised 1:1 to either colchicine plus high-intensity rosuvastatin in addition to standard of care versus standard of care alone. Assigned treatment was continued for the duration of index hospitalisation or 30 days, whichever was shorter.Primary and secondary outcome measuresThe prespecified primary endpoint was progression to severe COVID-19 disease (new high-flow or non-invasive ventilation, mechanical ventilation, need for vasopressors, renal replacement therapy or extracorporeal membrane oxygenation, or death) or arterial/venous thromboembolic events (ischaemic stroke, myocardial infarction, deep venous thrombosis or pulmonary embolism) evaluated at 30 days.ResultsAmong the 250 patients randomised in this trial (125 to each arm), the median age was 61 years, 44% were women, 15% were Black and 26% were Hispanic/Latino. As part of the standard of care, patients received remdesivir (87%), dexamethasone (92%), tocilizumab (18%), baricitinib (2%), prophylactic/therapeutic anticoagulation (98%) and aspirin (91%). The trial was terminated early by the data and safety monitoring board for futility. No patients were lost to follow-up due to electronic medical record follow-up. There was no significant difference in the primary endpoint at 30 days between the active arm and standard of care arm (15.2% vs 8.8%, respectively, p=0.17).ConclusionsIn this small, open-label, randomised trial of non-critically ill hospitalised patients with COVID-19, the combination of colchicine and rosuvastatin in addition to standard of care did not appear to reduce the risk of progression of COVID-19 disease or thromboembolic events, although the trial was underpowered due to a lower-than-expected event rate. The trial leveraged the power of electronic medical records for efficiency and improved follow-up and demonstrates the utility of incorporating electronic medical records into future trials.Trial registrationNCT04472611.