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AIM: COVID-19 can lead to encephalopathy and loss of consciousness. This double-blinded randomized clinical trial conducted in Tehran, Iran, aimed to assess the potential effectiveness of modafinil in patients with COVID-19-related encephalopathy. METHODS: Nineteen non-intubated COVID-19 patients with encephalopathy were randomized into two groups: a treatment group receiving crushed modafinil tablets and a placebo group receiving starch powder. Modafinil was administered at a dose of 100 mg every 2 h, reaching a peak dosage of 400 mg. The level of consciousness was assessed using the Glasgow Coma Score (GCS) at multiple time points on the day of medication administration. The trial was registered under IRCT20170903036041N3 on 23/5/2021. RESULTS: The average age in the modafinil and placebo groups was 75.33 and 70 years, respectively. No significant differences were observed between the two groups in terms of chronic conditions, clinical symptoms, or laboratory data. GCS scores were similar between the groups at baseline (p-value = 0.699). After four doses of modafinil, GCS scores were slightly higher in the treatment group, but this difference was not statistically significant (p-value = 0.581). GCS scores after each round of drug administration didn't significantly differ between the treatment and placebo groups (p-value = 0.908). CONCLUSION: Modafinil exhibited a slight improvement in the level of consciousness among COVID-19 patients with encephalopathy, although this improvement did not reach statistical significance when compared to the control group. Further research with larger sample sizes and longer treatment durations is recommended to explore modafinil's potential benefits in managing altered consciousness in COVID-19 patients.
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OBJECTIVE: The coronavirus disease 2019 (COVID-19) pandemic had a significant impact on pregnant women and neonates in Iran. This retrospective study describes the national experience among neonates having suspected and confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection following hospital admission to examine the epidemiology, demographic, and clinical features. STUDY DESIGN: All nationwide cases of suspected and confirmed neonatal SARS-CoV-2 infection were drawn from the Iranian Maternal and Neonatal Network (IMaN) between February 2020 and February 2021. IMaN registers demographic, maternal, and neonatal health data throughout Iran. Statistical analysis of demographic, epidemiological, and clinical data were performed. RESULTS: There were 4,015 liveborn neonates having suspected or confirmed SARS-CoV-2 infection that fulfilled the study inclusion criteria identified in the IMaN registry from 187 hospitals throughout Iran. There were 1,392 (34.6%) neonates that were preterm, including 304 (7.6%) less than 32 weeks' gestation. Among the 2,567 newborns admitted to the hospital immediately after birth, the most common clinical problems were respiratory distress (1,095 cases; 42.6%), sepsis-like syndrome (355; 13.8%), and cyanosis (300 cases; 11.6%). Of 683 neonates transferred from another hospital, the most frequent problems were respiratory distress (388; 56.8%), sepsis-like syndrome (152; 22.2%), and cyanosis (134; 19.6%). Among 765 neonates discharged home after birth and subsequently admitted to the hospital, sepsis-like syndrome (244 cases; 31.8%), fever (210; 27.4%), and respiratory distress (185; 24.1%) were most frequent. A total of 2,331 (58%) of neonates required respiratory care, with 2,044 surviving and 287 having a neonatal death. Approximately 55% of surviving neonates received respiratory support, compared with 97% of neonates who expired. Laboratory abnormalities included elevations of white blood cell count, creatine phosphokinase, liver enzymes, and C-reactive protein. CONCLUSION: This report adds the national experience of Iran to the list of reports from multiple countries describing their experience with COVID-19 in neonates, demonstrating that newborns are not exempt from COVID-19-morbidity and mortality. KEY POINTS: · Most common clinical problem was respiratory distress.. · Sepsis-like syndrome was also frequently present.. · A total of 58% of all neonates required respiratory care..
