Background: Cardiac arrest is a common and devastating emergency of both the heart and brain. More than 380,000 patients suffer out-of-hospital cardiac arrest annually in the USA. Induced cooling of comatose patients markedly improved neurological and functional outcomes in pivotal randomized clinical trials, but the optimal duration of therapeutic hypothermia has not yet been established. Methods: This study is a multi-center randomized, response-adaptive, duration (dose) finding, comparative effectiveness clinical trial with blinded outcome assessment. We investigate two populations of adult comatose survivors of cardiac arrest to ascertain the shortest duration of cooling that provides the maximum treatment effect. The design is based on a statistical model of response as defined by the primary endpoint, a weighted 90-day mRS (modified Rankin Scale, a measure of neurologic disability), across the treatment arms. Subjects will initially be equally randomized between 12, 24, and 48 h of therapeutic cooling. After the first 200 subjects have been randomized, additional treatment arms between 12 and 48 h will be opened and patients will be allocated, within each initial cardiac rhythm type (shockable or non-shockable), by response adaptive randomization. As the trial continues, shorter and longer duration arms may be opened. A maximum sample size of 1800 subjects is proposed. Secondary objectives are to characterize: the overall safety and adverse events associated with duration of cooling, the effect on neuropsychological outcomes, and the effect on patient-reported quality of life measures. Discussion: In vitro and in vivo studies have shown the neuroprotective effects of therapeutic hypothermia for cardiac arrest. We hypothesize that longer durations of cooling may improve either the proportion of patients that attain a good neurological recovery or may result in better recovery among the proportion already categorized as having a good outcome. If the treatment effect of cooling is increasing across duration, for at least some set of durations, then this provides evidence of the efficacy of cooling itself versus normothermia, even in the absence of a normothermia control arm, confirming previous RCTs for OHCA survivors of shockable rhythms and provides the first prospective controlled evidence of efficacy in those without initial shockable rhythms. Trial registration: ClinicalTrials.gov NCT04217551. Registered on 30 December 2019.

When acquired during pregnancy, Zika virus (ZIKV) infection can cause substantial fetal morbidity, however, little is known about the long-term neurodevelopmental abnormalities of infants with congenital ZIKV exposure without microcephaly at birth. We conducted a cross sectional study to characterize infants born with microcephaly, and a retrospective cohort study of infants who appeared well at birth, but had possible congenital ZIKV exposure. We analyzed data from the Dominican Ministry of Health’s (MoH) National System of Epidemiological Surveillance. Neurodevelopmental abnormalities were assessed by pediatric neurologists over an 18-month period using Denver Developmental Screening Test II. Of 800 known live births from 1,364 women with suspected or confirmed ZIKV infection during pregnancy, 87 (11%) infants had confirmed microcephaly. Mean head circumference (HC) at birth was 28.1 cm (SD ± 2.1 cm) and 41% had a HC on the zero percentile for gestational age. Of 42 infants with possible congenital ZIKV exposure followed longitudinally, 52% had neurodevelopmental abnormalities, including two cases of postnatal onset microcephaly, during follow-up. Most abnormalities resolved, though two infants (4%) had neurodevelopmental abnormalities that were likely associated with ZIKV infection and persisted through 15–18 months. In the DR epidemic, 11% of infants born to women reported to the MoH with suspected or confirmed ZIKV during pregnancy had microcephaly. Some 4% of ZKV-exposed infants developed postnatal neurocognitive abnormalities. Monitoring of the cohort through late childhood and adolescence is needed.

This report describes years of potential life lost among adults in Chicago who experienced out-of-hospital cardiac arrest.

To evaluate the challenges encountered when using technology-based recruitment and electronic consenting to conduct social needs assessment of patients presenting with COVID-19-like illness at an urban academic emergency department. COVID-19 Testing Registry (CTR) was established in the emergency department of UI Health in Chicago, Illinois. An online survey platform REDCap (Research Electronic Data Capture) was used, through which a standardized text message was sent to the mobile devices of eligible patients who tested positive for COVID-19. Patients were first provided with information on social services (e.g., health, food, transportation, housing). After e-consent, they were then asked to complete a social and health needs assessment on the first day and 14th day after COVID-19 testing. Out of 153 patients invited to participate in the survey, 32 (21%) opened the link and accessed the survey, 13 (8%) accessed the information on resources, 22 (14%) replied to the question on interest in research participation, while 17 (11%) expressed interest in learning about CTR. Ultimately, only 6 (4%) consented and only 1 (0.6%) eventually completed both surveys. The mean age for the total invited pool was 39 (±16), while mean age for those who consented was 37 (±11). In our urban, mostly minority population, technology-based recruitment and electronic consent proved to be significantly low yield. In the future, CTR aims to further analyze predictors of lower patient engagement and widening disparity when using digital tools. Further data collection will be conducted using phone-call based procedures in patients who contracted COVID-19 in the first 6 months of the pandemic.