BACKGROUND The treatment of symptomatic congenital cytomegalovirus (CMV) disease with intravenous ganciclovir for 6 weeks has been shown to improve audiologic outcomes at 6 months, but the benefits wane over time. METHODS We conducted a randomized, placebo-controlled trial of valganciclovir therapy in neonates with symptomatic congenital CMV disease, comparing 6 months of therapy with 6 weeks of therapy. The primary end point was the change in hearing in the better ear (“best-ear” hearing) from baseline to 6 months. Secondary end points included the change in hearing from baseline to follow-up at 12 and 24 months and neurodevelopmental outcomes, with each end point adjusted for central nervous system involvement at baseline. RESULTS A total of 96 neonates underwent randomization, of whom 86 had follow-up data at 6 months that could be evaluated. Best-ear hearing at 6 months was similar in the 6-month group and the 6-week group (2 and 3 participants, respectively, had improvement; 36 and 37 had no change; and 5 and 3 had worsening; P = 0.41). Total-ear hearing (hearing in one or both ears that could be evaluated) was more likely to be improved or to remain normal at 12 months in the 6-month group than in the 6-week group (73% vs. 57%, P = 0.01). The benefit in total-ear hearing was maintained at 24 months (77% vs. 64%, P = 0.04). At 24 months, the 6-month group, as compared with the 6-week group, had better neurodevelopmental scores on the Bayley Scales of Infant and Toddler Development, third edition, on the language-composite component (P = 0.004) and on the receptive-communication scale (P = 0.003). Grade 3 or 4 neutropenia occurred in 19% of the participants during the first 6 weeks. During the next 4.5 months of the study, grade 3 or 4 neutropenia occurred in 21% of the participants in the 6-month group and in 27% of those in the 6-week group (P = 0.64). CONCLUSIONS Treating symptomatic congenital CMV disease with valganciclovir for 6 months, as compared with 6 weeks, did not improve hearing in the short term but appeared to improve hearing and developmental outcomes modestly in the longer term. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00466817.)

Background In the phase 1–2 portion of an adaptive trial, REGEN-COV, a combination of the monoclonal antibodies casirivimab and imdevimab, reduced the viral load and number of medical visits in patients with coronavirus disease 2019 (Covid-19). REGEN-COV has activity in vitro against current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern. Methods In the phase 3 portion of an adaptive trial, we randomly assigned outpatients with Covid-19 and risk factors for severe disease to receive various doses of intravenous REGEN-COV or placebo. Patients were followed through day 29. A prespecified hierarchical analysis was used to assess the end points of hospitalization or death and the time to resolution of symptoms. Safety was also evaluated. Results Covid-19–related hospitalization or death from any cause occurred in 18 of 1355 patients in the REGEN-COV 2400-mg group (1.3%) and in 62 of 1341 patients in the placebo group who underwent randomization concurrently (4.6%) (relative risk reduction [1 minus the relative risk], 71.3%; P<0.001); these outcomes occurred in 7 of 736 patients in the REGEN-COV 1200-mg group (1.0%) and in 24 of 748 patients in the placebo group who underwent randomization concurrently (3.2%) (relative risk reduction, 70.4%; P=0.002). The median time to resolution of symptoms was 4 days shorter with each REGEN-COV dose than with placebo (10 days vs. 14 days; P<0.001 for both comparisons). REGEN-COV was efficacious across various subgroups, including patients who were SARS-CoV-2 serum antibody–positive at baseline. Both REGEN-COV doses reduced viral load faster than placebo; the least-squares mean difference in viral load from baseline through day 7 was −0.71 log 10 copies per milliliter (95% confidence interval [CI], −0.90 to −0.53) in the 1200-mg group and −0.86 log 10 copies per milliliter (95% CI, −1.00 to −0.72) in the 2400-mg group. Serious adverse events occurred more frequently in the placebo group (4.0%) than in the 1200-mg group (1.1%) and the 2400-mg group (1.3%); infusion-related reactions of grade 2 or higher occurred in less than 0.3% of the patients in all groups. Conclusions REGEN-COV reduced the risk of Covid-19–related hospitalization or death from any cause, and it resolved symptoms and reduced the SARS-CoV-2 viral load more rapidly than placebo. (Funded by Regeneron Pharmaceuticals and others; ClinicalTrials.gov number, NCT04425629 .)

Hydrogen sulfide (H(2)S) is emerging as a physiological neuromodulator as well as a smooth muscle relaxant. We submit the first evidence that blood H(2)S levels are significantly lower in fasting blood obtained from type 2 diabetes patients compared with age-matched healthy subjects, and in streptozotocin-treated diabetic rats compared with control Sprague-Dawley rats. We further observed that supplementation with H(2)S or an endogenous precursor of H(2)S (l-cysteine) in culture medium prevents IL-8 and MCP-1 secretion in high-glucose-treated human U937 monocytes. These first observations led to the hypothesis that lower blood H(2)S levels may contribute to the vascular inflammation seen in diabetes.

The REALM-Teen is a brief, reliable instrument for assessing adolescent literacy skills and reading below grade level.

OBJECTIVES. The aims of this study were to determine parent and provider knowledge and awareness of newborn screening; to gather opinions from parents, providers, and newborn screening professionals about the content and timing of newborn screening education; and to use consensus data to formulate recommendations and to develop educational materials for parents and providers.METHODS. We conducted 22 focus groups and 3 individual interviews between October 2003 and May 2004, with English-and Spanish-speaking parents of infants Ͻ1 year of age who had experience with initial testing, retesting, or false-positive screenings; health professionals who provide prenatal care or health care for newborns; and state newborn screening program health professionals.RESULTS. Parents and providers had limited knowledge and awareness about newborn screening practices. Parents wanted brief to-the-point information on newborn screening and its benefits, including the possible need for retesting and the importance of returning promptly for retesting if initial results are abnormal. Parents wanted the information orally from the primary care provider. Parents, providers, and newborn screening professionals all thought that an accompanying concise, easy-to-read brochure with contact information would be helpful. All focus group participants thought that parents should receive this information before the birth of the infant, preferably in the third trimester of pregnancy. Providers wanted a brief checklist of information and resources to prepare them to educate parents effectively.CONCLUSIONS. We recommend prenatal and primary care providers be more involved in educating parents about newborn screening. Professional societies and state health officials should work together to encourage parent and provider education. User-friendly patient and provider education materials, such as those we developed, could form the basis for this educational approach. the United States operates a newborn screening program to test neonates for selected genetic and other disorders. State programs differ not only in the disorders for which testing is performed but also in the information given to parents and the process of reporting results, contacting parents, and referring them for care when an infant's test results are abnormal. [1][2][3] Newborn screening communication practices were recently addressed in a study by Kim et al, 1 who surveyed the program staff of all state newborn screening programs. Those investigators found that often the responsibility for informing parents about the testing is not clearly defined. Less than 50% of the states responded that primary care providers had some responsibility for informing parents about newborn screening, and only 25% indicated that they encouraged or required prenatal providers to educate parents. Most commonly, states reported that parents are informed about newborn screening procedures immediately before testing. Kim et al 1 concluded, "States should work with families, primary care physicians, ...

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Head lice infestation is associated with limited morbidity but causes a high level of anxiety among parents of school-aged children. Since the 2002 clinical report on head lice was published by the American Academy of Pediatrics, patterns of resistance to products available overthe-counter and by prescription have changed, and additional mechanical means of removing head lice have been explored. This revised clinical report clarifies current diagnosis and treatment protocols and provides guidance for the management of children with head lice in the school setting.